AzTrials
AzTrials

Colitis, UlcerativePhase 3ICONIC-UCNCT07196748

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 study testing Icotrokinra in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 402 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Icotrokinra
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
896 participants
Where
402 sitesin 28 countries
Study dates
1 Oct 2025to 13 Jan 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
  • Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
  • An endoscopy subscore greater than or equal to (>=) 2 as obtained during central review of the screening video endoscopy
  • Adolescent Participants: body weight must be >= 40 kilograms (kg) at baseline (Week I-0)
  • Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [β-hCG]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
  • Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder [IR]) as defined in the protocol

Who cannot join

  • Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
  • Presence of a stoma
  • Presence or history of a fistula
  • Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
  • History of extensive colonic resection (that is, less than [<] 30 centimeter [cm] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention

Trial locations and contacts

402 sites in 28 countries.

402 sites in 28 countries

United States56 sites

  • Clinnova Research

    Anaheim, California, 92805

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Children's Center for Digestive Health Care

    Atlanta, Georgia, 30342

  • The University of Texas at Austin

    Austin, Texas, 78712

  • Westchester Putnam Gastroenterology

    Carmel, New York, 10512

  • DFW Clinical Trials

    Carrollton, Texas, 75010

  • AZ Gastro Care

    Chandler, Arizona, 85206

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Atrium Health

    Charlotte, North Carolina, 28204

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Southern California Research Center

    Coronado, California, 92118

  • Tri-State Gastroenterology Assoc

    Crestview Hills, Kentucky, 41017

  • American Institute of Research

    Cutler Bay, Florida, 33157

  • Nuvance Health Danbury Hospital

    Danbury, Connecticut, 06810

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland, 21061

  • Susquehanna Research Group

    Harrisburg, Pennsylvania, 17110-3673

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Penn State Milton S Hershey Medical Ctr

    Hershey, Pennsylvania, 17033

  • Victorium Clinical Research

    Houston, Texas, 77024

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Om Research LLC

    Lancaster, California, 93534

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • TLC Clinical Research Inc

    Los Angeles, California, 90048

  • GastroIntestinal Bioscience

    Los Angeles, California, 90067

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Gastroenterolgy Associates of Central GA

    Macon, Georgia, 31201

  • Inflammatory Bowel Disease Center at NYU Langone

    New York, New York, 10016

  • Manhattan Clinical Research LLC

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Weill Cornell Medical College

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • New York Gastroenterology Associates

    New York, New York, 10075

  • Hoag Memorial Hospital

    Newport Beach, California, 92658

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73114

  • Om Research LLC 2

    Oxnard, California, 93030

  • Stanford Medicine Children's Health

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Jefferson Digestive Health Institute

    Philadelphia, Pennsylvania, 19107

  • The Oregon Clinic

    Portland, Oregon, 97220-9428

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Digestive Disease Associates

    Rock Hill, South Carolina, 29732

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

  • Clinical Applications Laboratories, Inc

    San Diego, California, 92103

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • University of California San Francisco

    San Francisco, California, 94115

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • GI Alliance Southlake

    Southlake, Texas, 76092

  • GI Alliance Tacoma

    Tacoma, Washington, 98405

  • GCP Clinical Research

    Tampa, Florida, 33609

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas, 66606

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Delta Research Partners, LLC

    West Monroe, Louisiana, 71291

Other trials in United States

China34 sites

  • Peking Union Medical College Hospital

    Beijing, 100006

  • China Japan Friendship Hospital

    Beijing, 100029

  • Capital Medical University, Beijing Friendship Hospital

    Beijing, 100050

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213003

  • West China School of Medicine/West China Hospital, Sichuan University

    Cheng Du Shi, 610041

  • Chongqing General Hospital

    Chongqing, 400014

  • The First People's Hospital of Foshan

    Foshan, 528010

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350004

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • The Sixth Affiliated Hospital Sun Yat sen University

    Guangzhou, 510655

  • Affiliated Hospital of Hainan Medical University

    Haikou, 570102

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310000

  • Heilongjiang Provincial Hospital

    Harbin, 150036

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Huizhou Central People's Hospital

    Huizhou, 516001

  • Lanzhou University Second Hospital

    Lanzhou, 730030

  • The first affiliated hospital of Henan University of science and technology

    Luoyang, 471000

  • The affiliated hospital of Southwest Medical University

    Luzhou, 646000

  • Zhongda Hospital Southeast University

    Nanjing, 210000

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    Nanjing, 210004

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315211

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200127

  • Shengjing Hospital Of China Medical University

    Shenyang, 110022

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050090

  • The Second Affiliatted Hospital of Soochow University

    Suzhou, 215000

  • Taian City Central Hospital

    Taian, 271000

  • Meihekou Central Hospital

    Tonghua, 135022

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • The Central Hospital of Wuhan

    Wuhan, 430014

  • Wuxi People s Hospital

    Wuxi, 214023

  • Northern Jiangsu Peoples Hospital

    Yangzhou, 225001

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, 563099

Other trials in China

Japan34 sites

  • Juntendo University Hospital Urayasu

    Chiba, 279 0021

  • Ginza central clinic

    Chūōku, 1040061

  • Sai Gastroenterology Proctology

    Fujiidera-shi, 583-0027

  • Fukui Prefectural Hospital

    Fukui-shi, 910-8526

  • Saiseikai Fukuoka General Hospital

    Fukuoka, 810-0001

  • Gamagori City Hospital

    Gamagōri, 443-8501

  • Matsuda Hospital

    Hamamatsu, 432-8061

  • National Hospital Organization Mito Medical Center

    Higashiibaraki-gun, 311-3193

  • Hirosaki General Medical Center

    Hirosaki, 036-8545

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, 920-8650

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu, 807-8556

  • Kobe University Hospital

    Kobe, 650 0017

  • Aoyama Naika Clinic

    Kobe, 650-0015

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

  • Takano Hospital

    Kumamoto, 862-0971

  • Kurume University Hospital

    Kurume, 830-0011

  • Kyorin University Hospital

    Mitaka, 181-8611

  • Takagi Clinic

    Miyagi, 981-3213

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501

  • Oita Red Cross Hospital

    Ōita, 870-0033

  • Nakagami Hospital

    Okinawa, 904-2195

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • National Hospital Organization Osaka National Hospital

    Osaka, 540 0006

  • Japanese Red Cross Osaka Hospital

    Osaka, 543-8555

  • Sapporo Tokushukai Hospital

    Sapporo, 004-0041

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

    Sapporo, 060-0033

  • Tohoku University Hospital

    Sendai, 980 8574

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575

  • National Hospital Organization Shizuoka Medical Center

    Sunto-gun, 411-8611

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

Poland29 sites

  • Centrum Medyczne Medis ManerMed Sp Z O O

    Bydgoszcz, 85 229

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, 85 231

  • Osrodek Badan Klinicznych CLINSANTE S C

    Bydgoszcz, 85 794

  • Vita Longa Sp z o o

    Katowice, 40 748

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30 002

  • Centrum Medyczne Plejady

    Krakow, 30 363

  • Promed P. Lach R. Glowacki Sp.j. Centrum Medyczne Promed

    Krakow, 31-513

  • Medrise Sp. z o.o.

    Lublin, 20 582

  • Allmedica

    Nowy Targ, 34 400

  • Medicus Zaniewski i Bilski

    Olsztyn, 10-684

  • Twoja Przychodnia

    Opole, 45-819

  • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp z o o

    Poznan, 60 354

  • RiverMED

    Poznan, 61 441

  • Centrum Medyczne 'Medyk' Sp. z o.o. K.

    Rzeszów, 35-055

  • Endoskopia Sp z o.o.

    Sopot, 81 756

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

  • GASTROMED Sp. z o.o.

    Torun, 87 100

  • Clinical Best Solutions Warszawa

    Warsaw, 00-710

  • Medon Clinical Research

    Warsaw, 02-679

  • WSD MEDI Clinical Sp. z o. o.

    Warsaw, 02-786

  • Bodyclinic Sp. z o.o. sp. k

    Warsaw, 03 712

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04 730

  • Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O

    Warsaw, 04-073

  • Medical Network WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

  • Centrum Medyczne Oporow

    Wroclaw, 52 416

  • Vistamed & Vertigo Sp Z O O

    Wroclaw, 53 149

  • EMC Instytut Medyczny S A Penta Hospitals Przychodnie

    Wroclaw, 54-239

  • ETG Zamosc

    Zamość, 22 400

Other trials in Poland

Brazil22 sites

  • Faculdade de Medicina Universidade Federal de Minas Gerais

    Belo Horizonte, 30130 100

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, 18618-686

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70200 730

  • Hospital Pequeno Principe

    Curitiba, 80250-060

  • CDC - Centro Digestivo de Curitiba

    Curitiba, 80430 180

  • ATO Terapias

    Fortaleza, 60140 025

  • CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda

    Jaú, 17201 130

  • Cliged

    Macaé, 27910-020

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062-000

  • Complexo Hospitalar de Niteroi

    Niterói, 24030-103

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-093

  • Hospital Moinhos de Vento

    Porto Alegre, 90560-032

  • Hospital da Crianca Santo Antonio de Porto Alegre

    Porto Alegre, 92020-430

  • Platano Centro De Pesquisa Clinica LTDA

    Recife, 52011 200

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14051140

  • Pesquisare Saude

    Santo André, 09080-110

  • BR Trials

    São Paulo, 01236030

  • Solare Trials

    São Paulo, 01307-000

  • IDOR - Regional Sao Paulo

    São Paulo, 01401 002

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05651 901

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 15500-269

Other trials in Brazil

India19 sites

  • Mazumdar Shaw Medical Centre - Narayana Hrudayalaya Limited

    Bangalore, 560099

  • Aster CMI Hospital

    Bengaluru, 560092

  • SUM Ultimate Medicare

    Bhubaneswar, 751003

  • Lisie Hospital

    Ernākulam, 682018

  • Fortis Memorial Research Institute

    Gurugram, 122002

  • Asian Institute Of Gastroenterology

    Hyderabad, 500032

  • Yashoda Super Speciality Hospitals 1

    Hyderabad, 500082

  • S. R. Kalla Memorial General Hospital

    Jaipur, 302001

  • Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines

    Ludhiana, 141001

  • Fortis Hospital

    Ludhiana, 141010

  • P D Hinduja National Hospital and Medical Research Center

    Mumbai, 400016

  • GB Pant Institute of Post Graduate Medical Education & Research

    New Delhi, 110002

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Indraprastha Apollo Hospital

    New Delhi, 1100776

  • All India Institute of Medical Sciences

    Patna, 801507

  • Yashoda Super Speciality Hospitals

    Secunderabad, 500003

  • SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre

    Surat, 395002

  • Gujarat Gastro and Vascular Hospital

    Surat, 395009

Other trials in India

France17 sites

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64109

  • CHU de Clermont Ferrand - Site Estaing

    Clermont-Ferrand, 63100

  • APHP - Hopital Henri Mondor

    Créteil, 94000

  • Institut Prive MICI Clinique des Cedres

    Échirolles, 38130

  • CHU de Lille Hopital Claude Huriez

    Lille, 59037

  • Hôpital Jeanne de FLANDRE, CHRU LILLE

    Lille, 59037

  • CHU de Limoges Hopital Dupuytren

    Limoges, 87042

  • GHI Le Raincy Montfermeil

    Montfermeil, 93370

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34090

  • Jules Verne Clinic

    Nantes, 44300

  • CHU de Nice Hopital de l Archet

    Nice, 06200

  • Hopital Saint-Antoine

    Paris, 75012

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604

  • Hospices Civils de Lyon CHU Lyon Sud

    Pierre-Bénite, 69495

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • CHU Toulouse - Hopital de Rangueil

    Toulouse, 31400

  • CHRU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Germany15 sites

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074

  • Krankenhaus Waldfriede Mitte

    Berlin, 14163

  • Medizinisches Versorgungszentrum (MVZ) Dachau

    Dachau, 85221

  • Universitaetsklinik Erlangen

    Erlangen, 91054

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 06108

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Praxisgemeinschaft Jerichow

    Jerichow, 39319

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105

  • Eugastro GmbH

    Leipzig, 04103

  • Staedtisches Klinikum Lueneburg

    Lüneburg, 21339

  • Dr. von Haunersches Kinderspital

    München, 80337

  • KUNO Klinik St. Hedwig

    Regensburg, 93049

  • Universitaetsmedizin Rostock

    Rostock, 18057

  • Universitaetsklinikum Ulm

    Ulm, 89081

  • HELIOS Klinikum Wuppertal GmbH

    Wuppertal, 42283

Other trials in Germany

Israel15 sites

  • Haemek Medical Center

    Afula, 1834111

  • Assuta MC

    Ashdod, 7747629

  • Shamir Medical Center Assaf Harofeh 1

    Be’er Ya‘aqov, 70300

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 3109601

  • Shaare Zedek Medical Center 1

    Jerusalem, 9103102

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Galilee Medical Center

    Nahariya, 22100

  • Schneider Children's Medical Center

    Petah Tikva, 4920235

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center 1

    Ramat Gan, 52621

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center 1

    Tel Aviv, 64239

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Hungary13 sites

  • Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz

    Békéscsaba, 5600

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Semmelweis Egyetem 1

    Budapest, 1082

  • Semmelweis Egyetem

    Budapest, 1083

  • Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088

  • Pannónia Magánorvosi Centrum Kft

    Budapest, H-1136

  • Vasutegeszsegugyi Nonprofit Kozhasznu Kft

    Debrecen, 4025

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400

  • Szegedi Tudomanyegyetem Aok Szent Gyorgyi Albert Klinikai Kozpont 1

    Szeged, 6720

  • Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725

  • Clinfan Ltd. SMO

    Szekszárd, 7100

  • Szent Borbala Hospital Tatabanya

    Tatabánya, 2800

Other trials in Hungary

Czechia12 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Vojenska nemocnice Brno

    Brno, 636 00

  • Nemocnice Ceske Budejovice

    České Budějovice, 370 01

  • Centrum gastroenterologie a hepatologie s.r.o.

    Kladno, 27280

  • PreventaMed, s.r.o.

    Olomouc, 77900

  • Gastromedic, Ltd.

    Pardubice, 530 03

  • Všeobecná fakultní nemocnice v

    Prague, 128 08

  • AXON Clinical s.r.o.

    Prague, 140 00

  • Fakultni Thomayerova nemocnice

    Prague, 140 59

  • Clinoxus s r o

    Prague, 14000

  • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze

    Praha 1- Mala Strana, 118 33

  • MUDr. Michal Konecny, Ph.D. s.r.o.

    Přerov, 750 02

Other trials in Czechia

Spain12 sites

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Sant Joan de Deu

    Barcelona, 08950

  • Hosp. Arquitecto Marcide

    Ferrol, 15405

  • Hosp. Galdakao-Usansolo

    Galdakao, 48960

  • Hosp. de Cabuenes

    Gijón, 33394

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007

  • Hosp. Univ. de La Princesa

    Madrid, 28006

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Argentina11 sites

  • GEDYT

    AAI, C1425BGC

  • Cer Instituto Medico

    Buenos Aires, 1878

  • Kynet Recoleta

    Buenos Aires, C1119

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • Instituto de Investigaciones Clinicas T y T

    Caba, C1405

  • CIPREC

    CABA, C1061AAS

  • Clinica Universitaria Reina Fabiola

    Córdoba, X5004FHP

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Hospital Sor Maria Ludovica de La Plata

    La Plata, B1904

  • Sanatorio Maipu

    Maipu, M5515

  • HIGEA

    Mendoza, M5500

Other trials in Argentina

Canada11 sites

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • South Edmonton Gastroenterology Research Clinic

    Edmonton, Alberta, Code: T6K

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

  • Viable Clinical Research

    Kentville, Nova Scotia, B4N 0A3

  • London Digestive Disease Institute

    London, Ontario, N6K 1M6

  • West GTA Research Inc

    Mississauga, Ontario, L5M 2S4

  • CHUM - Centre hospitalier universitaire de Montreal

    Montreal, Quebec, H2X 0C1

  • Clinique IMD

    Montreal, Quebec, H3H1E8

  • ABP Research Services Corp.

    Oakville, Ontario, L6L 5L7

  • Toronto Immune and Digestive Health Institute Inc

    Toronto, Ontario, M6A 3B4

  • GIRI Gastrointestinal Research Institute

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

South Korea11 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Yeungnam University Hospital

    Daegu, 42415

  • The Catholic University of Korea Daejeon St Mary's Hospital

    Daejeon, 34943

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Kyung Hee University Hospital

    Seoul, 130 050

  • Asan Medical Center

    Seoul, 138-040

  • The Catholic university of Korea, St. Vincent's Hospital

    Suwon, 16247

Other trials in South Korea

Turkey (Türkiye)11 sites

  • Hacettepe University Medical Faculty

    Ankara, 06230

  • Gazi University Hospital 1

    Ankara, 06560

  • Gazi University Hospital

    Ankara, 06560

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Antalya Training And Research Hospital

    Antalya, 07100

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Marmara University Istanbul Pendik Education and Research Hospital

    Istanbul, 34890

  • Marmara University Istanbul Pendik Education and Research Hospital 1

    Istanbul, 34899

  • Ege University Medical Faculty

    Izmir, 35040

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

  • Mersin University Medical Faculty Hospital

    Mersin, 33110

Other trials in Turkey (Türkiye)

Belgium10 sites

  • CHU Saint-Pierre

    Brussels, 1000

  • Huderf

    Brussels, 1020

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • AZ St. Lucas

    Ghent, 9000

  • Ghent University Hospital

    Ghent, 9000

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, 4000

  • AZ Oostende

    Ostend, 8400

  • CHwapi

    Tournai, 7500

Other trials in Belgium

Italy9 sites

  • A O U Sant Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Ospedale San Raffaele di Milano

    Milan, 20132

  • ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi

    Milan, 20154

  • Ospedale Sacro Cuore Negrar-Verona

    Negrar-Verona, 37024

  • Azienda Ospedaliera San Camillo-Forlanini

    Roma, 00152

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013

Other trials in Italy

United Kingdom9 sites

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Royal Hospital for Children and Young People

    Edinburgh, EH16 4TJ

  • Fairfield General Hospital

    Greater Manchester, BL9 7TD

  • Whipps Cross University Hospital

    London, E11 1NR

  • Kings College Hospital

    London, SE5 9RS

  • St Georges University Hospitals NHS Foundation Trust

    London, SW17 0QT

  • Whiston Hospital

    Rainhill, L35 5DR

  • Sheffield Children's Hospital

    Sheffield, S10 2TH

  • Stepping Hill Hospital

    Stockport, SK2 7JE

Other trials in United Kingdom

Greece8 sites

  • Evangelismos S A

    Athens, 106 76

  • Hippokration Hospital

    Athens, 115 27

  • Alexandra General Hospital of Athens

    Athens, 115 28

  • Thoracic General Hospital Of Athens I Sotiria

    Athens, 11527

  • University General Hospital of Heraklion

    Heraklion, 715 00

  • Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon

    Nikaia, 184 54

  • Geniko Nosokomeio Peiraia Tzaneio

    Piraeus, 18536

  • Theageneio Cancer Hospital

    Thessaloniki, 546 39

Other trials in Greece

Australia7 sites

  • Monash Health

    Clayton, 3168

  • Concord Repatriation General Hospital

    Concord, 2139

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Fiona Stanley Hospital

    Murdoch, 6150

  • John Hunter Hospital

    New Lambton, 2305

  • Royal Melbourne Hospital

    Parkville, 3050

  • Mater Hospital Brisbane

    South Brisbane, 4101

Other trials in Australia

Malaysia7 sites

  • Hospital Sultanah Bahiyah

    Alor Star, 05460

  • Hospital Ampang

    Ampang, 68000

  • Hospital Sultanah Aminah

    Johor Bahru, 80100

  • Sultan Idris Shah Hospital

    Kajang, 43000

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

Other trials in Malaysia

Sweden7 sites

  • Alingsas lasarett

    Allingsas, 441 83

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Linkoping University Hospital

    Linköping, 58185

  • Orebro universitetssjukhus

    Örebro, 703 82

  • Ersta sjukhus

    Stockholm, 116 30

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76

  • Akademiska Sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Portugal6 sites

  • Uls Braga - Hosp. Braga

    Braga, 4710 243

  • Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

    Guimarães, 4835 044

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 028

  • Uls Loures Odivelas - Hosp. Loures

    Loures, 2674-514

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4050 385

  • Ulsam - Hosp. Santa Luzia

    Viana do Castelo, 4900-408

Other trials in Portugal

Romania6 sites

  • S C Delta Health Care S R L

    Bucharest, 014142

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor

    Cluj-Napoca, 400394

  • Gastromed S R L

    Constanța, 900600

  • Spitalul Clinic Judetean de Urgenta Craiova

    Craiova, 200147

  • Spitalul Clinic Judetean Sibiu

    Sibiu, 550245

Other trials in Romania

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 104

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Netherlands3 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HV

  • Maastricht UMC

    Maastricht, 6229 HX

  • Radboud Umcn

    Nijmegen, 6525 GA

Other trials in Netherlands

Switzerland3 sites

  • Department of Visceral Surgery and Medicine

    Bern, 3010

  • HOCH Health Ostschweiz Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

Being tested
Icotrokinra, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IcotrokinraDrug

    Also called JNJ-77242113

    Icotrokinra tablet will be administered orally.

  • PlaceboDrug

    Placebo tablet will be administered orally.

Study groups in NCT07196748
Study groupRoleWhat they receive
Double-blind (DB) Induction Study: IcotrokinraExperimentalAdult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
Receives: Drug: Icotrokinra
DB Induction Study: PlaceboPlacebo comparatorAdult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
Receives: Drug: Placebo
DB Maintenance Study: IcotrokinraExperimentalAdult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE).
Receives: Drug: Icotrokinra
DB Maintenance Study: PlaceboPlacebo comparatorAdult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE.
Receives: Drug: Placebo
Open-label (OL) Induction Phase: IcotrokinraExperimentalAdolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase.
Receives: Drug: Icotrokinra
OL Maintenance Phase: IcotrokinraExperimentalAdolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE.
Receives: Drug: Icotrokinra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12

    Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

    Measured: At Week I-12

  2. DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40

    Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

    Measured: At Week M-40

  3. Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40

    Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

    Measured: At Week M-40

Secondary outcomes (44)

  1. DB Induction Study: Percentage of Adult Participants in Clinical Response at Week I-12

    Percentage of adult participants in clinical response at Week I-12 will be reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

    Measured: At Week I-12

  2. DB Induction Study: Percentage of Adult Participants with Endoscopic Improvement at Week I-12

    Percentage of adult participants with endoscopic improvement at Week I-12 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

    Measured: At Week I-12

  3. DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-12

    Percentage of adult participants in symptomatic remission at Week I-12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

    Measured: At Week I-12

  4. DB Induction Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12

    Percentage of adult participants with IBDQ remission at Week I-12 will be reported. IBDQ remission is defined as an IBDQ total score of >= 170. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Measured: At Week I-12

  5. DB Induction Study: Percentage of Adult Participants with Histologic-Endoscopic Mucosal Improvement (HEMI) at Week I-12

    Percentage of adult participants with HEMI at Week I-12 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (<) 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.

    Measured: At Week I-12

  6. DB Induction Study: Percentage of Adult Participants with Fatigue Response at Week I-12

    Percentage of adult participants with fatigue response at Week I-12 will be reported. Fatigue response is defined as a >= 7-point reduction in the patient-reported outcomes measurement information system (PROMIS)-fatigue Short Form (SF)-7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).

    Measured: At Week I-12

  7. DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-4

    Percentage of adult participants in symptomatic remission at Week I-4 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

    Measured: At Week I-4

  8. DB Induction Study: Percentage of Adult Participants in Endoscopic Remission at Week I-12

    Percentage of adult participants in endoscopic remission at Week I-12 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.

    Measured: At Week I-12

  9. DB Induction Study: Percentage of Adult Participants with No Bowel Urgency at Week I-12

    Percentage of adult participants with no bowel urgency at Week I-12 will be reported using the ulcerative colitis patient-reported outcomes signs and symptoms (UC-PRO/SS). The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of gastrointestinal (GI) signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

    Measured: At Week I-12

  10. DB Induction Study: Percentage of Adult Participants with No Abdominal Pain at Week I-12

    Percentage of adult participants with no abdominal pain at Week I-12 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

    Measured: At Week I-12

  11. DB Induction Study: Percentage of Adult Participants with No Bowel Incontinence at Week I-12

    Percentage of adult participants with no bowel incontinence at Week I-12 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

    Measured: At Week I-12

  12. DB Induction Study: Percentage of Adult Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Percentage of adult participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important.

    Measured: Up to Week I-12

  13. DB Maintenance Study: Percentage of Adult Participants with Endoscopic Improvement at Week M-40

    Percentage of adult participants with endoscopic improvement at Week M-40 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

    Measured: At Week M-40

  14. DB Maintenance Study: Percentage of Adult Participants in Symptomatic Remission at Week M-40

    Percentage of adult participants in symptomatic remission at Week M-40 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

    Measured: At Week M-40

  15. DB Maintenance Study: Percentage of Adult Participants with 90-day Corticosteroid-free Clinical Remission at Week M-40

    Percentage of adult participants with 90-day corticosteroid-free clinical remission at Week M-40 will be reported. 90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.

    Measured: At Week M-40

  16. DB Maintenance Study: Percentage of Adult Participants with HEMI at Week M-40

    Percentage of adult participants with HEMI at Week M-40 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.

    Measured: At Week M-40

  17. DB Maintenance Study: Percentage of Adult Participants with IBDQ Remission at Week M-40

    Percentage of adult participants with IBDQ remission at Week M-40 will be reported. IBDQ remission is defined as an IBDQ total score of >= 170. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific HRQoL across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Measured: At Week M-40

  18. DB Maintenance Study: Percentage of Adult Participants in Endoscopic Remission at Week M-40

    Percentage of adult participants in endoscopic remission at Week M-40 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.

    Measured: At Week M-40

  19. DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline

    Percentage of adult participants in clinical remission at Week M-40 among the participants who had achieved clinical remission at maintenance baseline will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

    Measured: At Week M-40

  20. DB Maintenance Study: Percentage of Adult Participants in Histologic-Endoscopic Mucosal Remission at Week M-40

    Percentage of adult participants in histologic-endoscopic mucosal remission at Week M-40 will be reported. Histologic-endoscopic mucosal remission is defined as achieving a combination of histologic remission and endoscopic remission. Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic remission is defined as an endoscopy subscore of 0.

    Measured: At Week M-40

  21. DB Maintenance Study: Percentage of Adult Participants with Fatigue Response at Week M-40

    Percentage of adult participants with fatigue response at Week M-40 will be reported. Fatigue response is defined as a >= 7-point reduction in the PROMIS-fatigue SF-7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).

    Measured: At Week M-40

  22. DB Maintenance Study: Percentage of Adult Participants with Disease Clearance at Week M-40

    Percentage of adult participants with disease clearance at Week M-40 will be reported. Disease clearance is defined as a composite of symptomatic remission and histologic-endoscopic mucosal remission. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Histologic-endoscopic mucosal remission is defined as achieving a combination of histologic remission and endoscopic remission.

    Measured: At Week M-40

  23. DB Maintenance Study: Percentage of Adult Participants with No Bowel Urgency at Week M-40

    Percentage of adult participants with no bowel urgency at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

    Measured: At Week M-40

  24. DB Maintenance Study: Percentage of Adult Participants with No Abdominal Pain at Week M-40

    Percentage of adult participants with no abdominal pain at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

    Measured: At Week M-40

  25. DB Maintenance Study: Percentage of Adult Participants with No Bowel Incontinence at Week M-40

    Percentage of adult participants with no bowel incontinence at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.

    Measured: At Week M-40

  26. DB Maintenance Study: Percentage of Adult Participants with AEs and SAEs

    Percentage of adult participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.

    Measured: Up to Week M-40

  27. OL Induction Phase: Percentage of Adolescent Participants in Clinical Response at Week I-12

    Percentage of adolescent participants in clinical response at Week I-12 will be reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

    Measured: At Week I-12

  28. OL Induction Phase: Percentage of Adolescent Participants in Clinical Remission at Week I-12

    Percentage of adolescent participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

    Measured: At Week I-12

  29. OL Induction Phase: Percentage of Adolescent Participants with HEMI at Week I-12

    Percentage of adolescent participants with HEMI at Week I-12 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (<) 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.

    Measured: At Week I-12

  30. OL Induction Phase: Percentage of Adolescent Participants with Endoscopic Improvement at Week I-12

    Percentage of adolescent participants with endoscopic improvement at Week I-12 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

    Measured: At Week I-12

  31. OL Induction Phase: Percentage of Adolescent Participants in Symptomatic Remission at Week I-12

    Percentage of adolescent participants in symptomatic remission at Week I-12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

    Measured: At Week I-12

  32. OL Induction Phase: Percentage of Adolescent Participants in Endoscopic Remission at Week I-12

    Percentage of adolescent participants in endoscopic remission at Week I-12 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.

    Measured: At Week I-12

  33. OL Induction Phase: Percentage of Adolescent Participants in Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week I-12

    Percentage of adolescent participants in PUCAI remission at Week I-12 will be reported. PUCAI remission is defined as a PUCAI score <10. The PUCAI is a non-invasive instrument for measuring disease activity in adolescents with UC. Disease activity is determined as a score based on evaluation of abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score ranges from 0 to 85.

    Measured: At Week I-12

  34. OL Induction Phase: Percentage of Adolescent Participants with AEs and SAEs

    Percentage of adolescent participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.

    Measured: Up to Week I-12

  35. OL Maintenance Study: Percentage of Adolescent Participants with Endoscopic Improvement at Week M-40

    Percentage of adolescent participants with endoscopic improvement at Week M-40 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

    Measured: At Week M-40

  36. OL Maintenance Phase: Percentage of Adolescent Participants in Symptomatic Remission at Week M-40

    Percentage of adolescent participants in symptomatic remission at Week M-40 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

    Measured: At Week M-40

  37. OL Maintenance Phase: Percentage of Adolescent Participants in 90-day Corticosteroid-free Clinical Remission at Week M-40

    Percentage of adolescent participants in 90-day corticosteroid-free clinical remission at Week M-40 will be reported. 90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.

    Measured: At Week M-40

  38. OL Maintenance Phase: Percentage of Adolescent Participants with HEMI at Week M-40

    Percentage of adolescent participants with HEMI at Week M-40 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.

    Measured: At Week M-40

  39. OL Maintenance Phase: Percentage of Adolescent Participants with Histologic-Endoscopic Mucosal Remission at Week M-40

    Percentage of adolescent participants with histologic-endoscopic mucosal remission at Week M-40 will be reported. Histologic-endoscopic mucosal remission is defined as achieving a combination of histologic remission and endoscopic remission. Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic remission is defined as an endoscopy subscore of 0.

    Measured: At Week M-40

  40. OL Maintenance Phase: Percentage of Adolescent Participants with Endoscopic Remission at Week M-40

    Percentage of adolescent participants with endoscopic remission at Week M-40 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.

    Measured: At Week M-40

  41. OL Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline

    Percentage of adolescent participants in clinical remission at Week M-40 among the participants who had achieved clinical remission at maintenance baseline will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

    Measured: At Week M-40

  42. OL Maintenance Phase: Percentage of Adolescent Participants in Clinical Response at Week M-40 Among the Participants who had Achieved Clinical Response at Maintenance Baseline

    Percentage of adolescent participants in clinical response at Week M-40 among the participants who had achieved clinical response at maintenance baseline will be reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by >= 30 % and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

    Measured: At Week M-40

  43. OL Maintenance Phase: Percentage of Adolescent Participants in PUCAI Remission at Week-40

    Percentage of adolescent participants in PUCAI remission at Week M-40 will be reported. PUCAI remission is defined as a PUCAI score <10. The PUCAI is a non-invasive instrument for measuring disease activity in adolescents with UC. Disease activity is determined as a score based on evaluation of abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score ranges from 0 to 85.

    Measured: At Week M-40

  44. OL Maintenance Phase: Percentage of Adolescent Participants with AEs and SAEs

    Percentage of adolescent participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.

    Measured: Up to Week M-40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start1 Oct 2025
  3. Primary completion14 Jan 2028 (estimated)
  4. Study completion13 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment applies to adult participants only.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
896 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07196748
Sponsor's protocol ID
77242113UCO3001
Other IDs
2025-521381-10-00, 2025
Acronym
ICONIC-UC
Status last verified
Nov 2026
First submitted
22 Sep 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Icotrokinra in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 402 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 402 sites in United States, China, Japan, Poland, Brazil and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 (time frame: At Week I-12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07196748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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