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AzTrials

Arthritis, PsoriaticPhase 3ICONIC-PsA 1NCT06878404

A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis

A Phase 3 study testing Icotrokinra and Active reference comparator in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 155 sites in 16 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 study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Icotrokinra and Active reference comparator
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
552 participants
Where
155 sitesin 16 countries
Study dates
21 Feb 2025to 4 Feb 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
  • Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
  • Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
  • Have active plaque psoriasis with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with psoriasis
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Who cannot join

  • Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
  • Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
  • Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease
  • Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

Trial locations and contacts

155 sites in 16 countries.

155 sites in 16 countries

China23 sites

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Tong Ren Hospital Capital Medical University

    Beijing, 100730

  • The First Bethune Hospital of Jilin University

    Changchun, 130021

  • Xiangya Hospital Central South University

    Changsha, 410008

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 4000016

  • Nanfang Hospital of Southern Medical Hospital

    Guangzhou, 510515

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 561113

  • Linyi City People Hospital

    Linyi, 276002

  • Jiangxi Provincial Peoples Hospital

    Nanchang, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330008

  • Affiliated Hospital of Nantong University

    Nantong, 226001

  • Pingxiang People's Hospital

    Pingxiang, 337055

  • Huashan Hospital Fudan University

    Shanghai, 200040

  • Shanghai skin disease hospital

    Shanghai, 200443

  • Shenzhen People s Hospital

    Shenzhen, 518020

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, 050051

  • Second Affiliated Hospital of Soochow University

    Suzhou, 215000

  • Shanxi Bethune Hospital

    Taiyuan, 030032

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710006

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212001

Other trials in China

Poland20 sites

  • Osteo Medic S C Artur Racewicz Jerzy Supronik

    Bialystok, 15-351

  • Specderm Poznanska sp j

    Bialystok, 15-375

  • ClinicMed Daniluk Nowak Spolka Komandytowa

    Bialystok, 15-879

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Ambulatorium sp. z o.o.

    Elblag, 82-300

  • Centrum Kliniczno Badawcze

    Elblag, 82-300

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002

  • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

    Krakow, 30-002

  • Centrum Medyczne All Med

    Krakow, 30-033

  • Pratia MCM Krakow

    Krakow, 30-727

  • Dermed Centrum Medyczne Sp z o o

    Lodz, 90-265

  • Zespol Poradni Specjalistycznych Reumed Filia nr 1

    Lublin, 20-607

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05-830

  • Etyka Osrodek Badan Klinicznych

    Olsztyn, 10-117

  • MICS Centrum Medyczne Torun

    Torun, 87-100

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

  • Centrum Medyczne Reuma Park

    Warsaw, 02-665

  • DermMedica Sp z o o

    Wroclaw, 51-503

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

Czechia13 sites

  • RHEUMA s r o

    Břeclav, 690 02

  • Revmatologie s r o

    Brno, 63800

  • Revmacentrum MUDr Mostera s r o

    Brno-Židenice, 615 00

  • L K N Arthrocentrum

    Hlučín, 748 01

  • Revimex Pro s r o

    Karvina Frystat, 73301

  • CCR Ostrava S R O

    Ostrava, 70200

  • MUDr Rosypalova s r o

    Ostrava, 70800

  • Revmatologicky ustav

    Prague, 128 00

  • Revmatologicka Ordinace

    Prague, 140 00

  • Thomayerova nemocnice

    Prague, 140 59

  • FN Motol

    Prague, 150 00

  • Medical Plus S R O

    Uherské Hradiště, 68601

  • PV Medical S R O

    Zlín, 76001

Other trials in Czechia

Hungary12 sites

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1027

  • Revita Kft

    Budapest, 1027

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Synexus Magyarorszag Kft

    Budapest, 1036

  • Qualiclinic Kft

    Budapest, 1134

  • Uno Medical Trials Ltd.

    Budapest, 1152

  • University of Debrecen

    Debrecen, 4032

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700

  • Obudai Egeszsegugyi Centrum Kft 1

    Kaposvár, 7400

  • University of Szeged

    Szeged, 6725

  • MAV Korhaz es Rendelointezet

    Szolnok, 5000

  • Vital Medical Center Orvosi es Fogaszati Kozpont

    Veszprém, 8200

Other trials in Hungary

Spain12 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Clinic de Barcelona

    Barcelona, 8036

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp Regional Univ de Malaga

    Málaga, 29009

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Infanta Luisa

    Seville, 41010

  • Hosp. Quiron Sagrado Corazon

    Seville, 41013

  • Hosp. Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Germany10 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Medizinische Fakultat der Albert Ludwigs Universitat Freiburg

    Freiburg im Breisgau, 79104

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Studienzentrum Dr Schwarz Germany

    Langenau, 89129

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Universitatsklinikum Tubingen

    Tübingen, 72076

Other trials in Germany

India10 sites

  • Marengo Cims Hospital

    Ahmedabad, 380060

  • Apollo Hospitals

    Bhubaneswar, 751005

  • Nizams Institute of Medical Sciences

    Hyderabad, 500082

  • Apollo Multispeciality Hospital Ltd

    Kolkata, 700054

  • Kokilaben Dhirubhai Ambani Hsp And Med Research Inst

    Mumbai, 400053

  • JSS Hospital

    Mysuru, 570004

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Indraprastha Apollo Hospital

    New Delhi, 1100776

  • Fortis Hospital

    Noida, 201301

  • SIDS Hospital & Research Centre

    Surat, 395002

Other trials in India

Japan10 sites

  • Fukuoka University Hospital

    Fukuoka, 814 0180

  • Kagawa University Hospital

    Kita Gun, 761 0793

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Maeshima Rheumatology Clinic

    Ōita, 870 0030

  • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

    Osaka, 550 0006

  • Sasebo Chuo Hospital

    Sasebo, 857 1195

  • Tohoku University Hospital

    Sendai, 980 8574

  • Teikyo University Hospital

    tabashi City, 173 8606

  • Kyorin University Hospital

    Tokyo, 181 8611

  • Mie University Hospital

    Tsu, 514 8507

Other trials in Japan

United States9 sites

  • Arthritis and Rheumatology Research Institute

    Allen, Texas, 75013

  • Joint and Muscle Research Institute

    Charlotte, North Carolina, 28204

  • Omega Research Consultants

    DeBary, Florida, 32713

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Naiara Alvarez MD Integrative Rheumatology of South TX

    Harlingen, Texas, 78550

  • Arthritis and Rheumatism Associates ARA Jonesboro

    Jonesboro, Arkansas, 72401

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida, 33324

  • Clinical Research of West Florida

    Tampa, Florida, 33606

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527

Other trials in United States

Argentina8 sites

  • Cosultorios Reumatologógicos Pampa

    Buenos Aires, 1428

  • Mindout Research

    Buenos Aires, C1417EYG

  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

    Buenos Aires, C1426BOS

  • Arsema

    Ciudad de Buenos Aires, C1431

  • Centro Medico Privado de Reumatologia Tucuman

    Ciudad de San Miguel de Tucuman, T4000AXL

  • Consultora Integral de Salud SRL

    Córdoba, CP5000

  • MR Medicina Reumatologica

    San Fernando, B1646GHP

  • Instituto Medico De Alta Complejidad (IMAC)

    San Isidro, B1642IPN

Other trials in Argentina

Denmark6 sites

  • Aarhus University Hospital

    Aarhus N, 8200

  • Sydvestjysk Sygehus

    Esbjerg, 6700

  • Frederiksberg Hospital

    Frederiksberg, 2000

  • Regionshospitalet Godstrup

    Herning, 7400

  • Svendborg Hospital Odense University Hospital

    Svendborg, 5700

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

Taiwan6 sites

  • National Taiwan University Hospital Hsin Chu Branch

    Hsinchu, 300

  • Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Medical Center Yong Kang

    Tainan, 710

  • Taipei Veterans General Hospital

    Taipei, 112

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Thailand6 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Rajavithi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Saraburi Hospital

    Changwat Sara Buri, 18000

  • Phra Nakhon Si Ayutthaya Hospital

    Phra Nakhon Si Ayutthaya, 13000

  • Songklanagarind hospital

    Songkhla, 90110

Other trials in Thailand

Australia5 sites

  • Ipswich Hospital

    Ipswich, 4305

  • Rheumatology Research Unit

    Maroochydore, 4558

  • BJC Health

    Parramatta, 2150

  • Queen Elizabeth Hospital

    South Woodville, 5011

  • Royal Darwin Hospital

    Tiwi, 0810

Other trials in Australia

Bulgaria4 sites

  • MC Medtech Services Ltd

    Haskovo, 6304

  • Exacta Medica

    Pleven, 5803

  • Medical Center Artmed

    Plovdiv, 4002

  • Medical Center Teodora

    Rousse, 7012

Other trials in Bulgaria

Hong Kong1 site

  • Prince of Wales Hospital

    Hong Kong, 000000

Other trials in Hong Kong

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants With Active Psoriatic Arthritis

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Being tested
Icotrokinra, Placebo, Active reference comparator
Medical subject headings
Arthritis, Psoriatic

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 will be administered.

  • PlaceboDrug

    Placebo will be administered.

  • Active reference comparatorDrug

    Active reference drug will be administered.

Study groups in NCT06878404
Study groupRoleWhat they receive
Group I: Icotrokinra Dose 1ExperimentalParticipants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
Receives: Drug: Icotrokinra
Group II: Icotrokinra Dose 2ExperimentalParticipants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.
Receives: Drug: Icotrokinra
Group III: PlaceboPlacebo comparatorParticipants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
Receives: Drug: Icotrokinra; Drug: Placebo
Group IV: Active Reference ComparatorActive comparatorParticipants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
Receives: Drug: Icotrokinra; Drug: Active reference comparator

What is being measured

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

  1. Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16

    The ACR 20 responders are participants with an improvement of greater than or equal to (>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

    Measured: Week 16

Secondary outcomes (14)

  1. Proportion of Participants Who Achieve Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and an IGA Score of >=2 at Baseline

    The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.

    Measured: Week 16

  2. Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline

    The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

    Measured: Week 16

  3. Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline

    The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score.

    Measured: Week 16

  4. Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline

    Proportion of participants with an IGA psoriasis score of 0 or 1 and >=2 grade improvement from baseline at week 16 among participants with >=3% BSA and an IGA score of >=2 at baseline will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema, and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

    Measured: Week 16

  5. Proportion of Participants who Achieve an ACR 50 Response at Week 16

    The ACR 50 responders are participants with an improvement of >= 50 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

    Measured: Week 16

  6. Proportion of Participants who Achieve an ACR 70 Response at Week 16

    The ACR 70 responders are participants with an improvement of >= 70 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

    Measured: Week 16

  7. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16

    The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Measured: From Baseline to Week 16

  8. Changes From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16

    SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains are averaged to calculate PCS. Total score range for PCS is 0-100 (100=highest level of physical functioning).

    Measured: From Baseline to Week 16

  9. Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline

    Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to lateral elbow epicondyle, left and right, medial femoral condyle, left and right, and achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Resolution is defined as participants have enteritis (LEI score >0) at baseline and no enthesis (LEO score =0) at the visit (week 16).

    Measured: Week 16

  10. Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline

    Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI total scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).

    Measured: From Baseline to Week 16

  11. Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline

    Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. Resolution is defined as participants have dactylitis (score >0) at baseline and no dactylitis (score =0) at the visit (week 16).

    Measured: Week 16

  12. Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline

    Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.

    Measured: From Baseline to Week 16

  13. Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16

    MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures: tender joint count less than or equal to (<=) 1; swollen joint count <= 1; psoriasis activity and severity index <= 1 or body surface area <= 3; patient pain VAS score of <= 15; patient global disease activity VAS (arthritis and psoriasis) score of <= 20; health assessment questionnaire (HAQ) score <= 0.5; and tender entheseal points <= 1.

    Measured: Week 16

  14. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16

    The FACIT-fatigue is a self-administered, 13-item questionnaire measuring items on tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses to all items are rated on a 5-point likert response scale ranging from 0 "not at all" to 4 "very much." The total score ranges from 0 to 52, with higher values indicating less fatigue.

    Measured: From Baseline to Week 16

Timeline

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

  1. First posted17 Mar 2025
  2. Study start21 Feb 2025
  3. Primary completion25 May 2026
  4. Study completion4 Feb 2028 (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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06878404
Sponsor's protocol ID
77242113PSA3001
Other IDs
77242113PSA3001, 2023-509239-19-00, 2023
Acronym
ICONIC-PsA 1
Status last verified
Nov 2026
First submitted
13 Mar 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 and Active reference comparator in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 155 sites in 16 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 5 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 155 sites in China, Poland, Czechia, Hungary, Spain and 11 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?

Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16 (time frame: Week 16). 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 NCT06878404.

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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