Colitis, UlcerativePhase 2ANTHEM-UCNCT06049017
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study testing JNJ-77242113 in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 177 sites in 21 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- JNJ-77242113
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 177 sitesin 21 countries
- Study dates
- 9 Oct 2023to 5 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Signed informed consent form 18 years of age or older
- Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
- Moderately to severely active UC as per the modified Mayo score
- Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Who cannot join
- Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
- UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
- Presence of a stoma
- Presence or history of fistula
- History of extensive colonic resection (example, <30 cm of colon remaining)
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
Trial locations and contacts
177 sites in 21 countries.
177 sites in 21 countries
United States32 sites
Clinnova Research
Anaheim, California, 92805
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Mercy Medical Center
Baltimore, Maryland, 21202-2102
Washington Gastroenterology, PLLC
Bellevue, Washington, 98004
UNC Hospitals
Chapel Hill, North Carolina, 27514
Atrium Health
Charlotte, North Carolina, 28204
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
DHAT Research Institute
Garland, Texas, 75044
Amel Med LLC Research
Georgetown, Texas, 78628
Gastroenterology Associates P.A.
Greenville, South Carolina, 29607
Accurate Clinical Research, Inc.
Humble, Texas, 77346
Ochsner Medical Center
Jefferson, Louisiana, 70121
I.H.S. Health. LLC
Kissimmee, Florida, 34741
Caprock Gastro Research
Lubbock, Texas, 79424
Tandem Clinical Research
Marrero, Louisiana, 70072
Gastroenterology of Southern Indiana
New Albany, Indiana, 47150
New York Gastroenterology Associates
New York, New York, 10075
Hoag Memorial Hospital
Newport Beach, California, 92663
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, 11758
Care Access Research, Ogden
Ogden, Utah, 84403
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112
Endoscopic Research Inc
Orlando, Florida, 32803-1853
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
Medical Associates Research Group, Inc.
San Diego, California, 92123
Washington Gastroenterology, PLLC 1
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
Northshore Gastroenterology Research, LLC
Westlake, Ohio, 44145
Japan14 sites
Sai Gastroenterology Proctology
Fujiidera-shi, 583-0027
Hamamatsu University Hospital
Hamamatsu, 431 3192
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871
Aoyama Naika Clinic
Kobe, 650-0015
Kinshukai Infusion Clinic
Osaka, 530-0011
Japanese Red Cross Osaka Hospital
Osaka, 543 8555
Toho University Sakura Medical Center
Sakura, 285-8741
Sapporo Tokushukai Hospital
Sapporo, 004-0041
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033
National Hospital Organization Shizuoka Medical Center
Shimizu, 411-8611
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, 130 8575
Mie University Hospital
Tsu, 514 8507
Yokohama City University Medical Center
Yokohama, 232 0024
China12 sites
The second Xiangya Hospital of Central South University
Changsha, 410011
Chongqing General Hospital
Chongqing, 400014
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510060
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, 510655
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310000
Qilu Hospital of Shandong University
Jinan, 250012
Lanzhou University Second Hospital
Lanzhou, 730031
Nanjing Drum Tower Hospital
Nanjing, 210008
Shengjing Hospital Of China Medical University
Shenyang, 110022
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022
Wuxi People s Hospital
Wuxi, 214023
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
Xi'an, 710038
Poland12 sites
Centrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz, 85 229
Centrum Medyczne Lukamed Spolka z Ograniczona Odpowiedzialnoscia
Chojnice, 89-600
Centrum Medyczne Plejady
Krakow, 30 363
Centrum Medyczne Medyk
Rzeszów, 35-326
Sonomed Sp. z o.o.
Szczecin, 71-685
GASTROMED Sp. z o.o.
Torun, 87 100
Centralny Szpital Kliniczny Mswia
Warsaw, 02 507
Bodyclinic Sp. z o.o. sp. k
Warsaw, 03 712
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04 501
Centrum Medyczne Oporow
Wroclaw, 52 416
Melita Medical Sp. z o.o.
Wroclaw, 53 611
EMC Instytut Medyczny SA
Wroclaw, 54 144
France11 sites
CHRU Besancon Hopital Jean Minjoz
Besançon, 25030
APHP - Hopital Henri Mondor
Créteil, 94000
CHRU de Lille Hopital Claude Huriez
Lille, 59037
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200
CHU de Nice Hopital de l Archet
Nice, 06202
CHU Nimes Hopital Caremeau
Nîmes, 30900
APHP - Hopital Bichat - Claude Bernard
Paris, 75018
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
CHU de Nancy_ Hopital Brabois
Vandœuvre-lès-Nancy, 54500
Spain11 sites
Hosp. Univ. Fundacion Alcorcon
Alcorcón, 28922
Hosp. Arquitecto Marcide
Ferrol, 15405
Hosp. de Cabuenes
Gijón, 33394
Hosp. Univ. La Paz
Madrid, 28046
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
Hosp. Virgen Macarena
Seville, 41009
Hosp. Ntra. Sra. de Valme
Seville, 41014
Hosp. Clinico Univ. de Valencia
Valencia, 46010
Hosp. Univ. I Politecni La Fe
Valencia, 46026
Hosp. Alvaro Cunqueiro
Vigo, 36312
United Kingdom9 sites
Fairfield General Hospital
Bury, Greater Manchester
Addenbrookes Hospital
Cambridge, CB2 0QQ
Barts Health NHS Trust
London, E11 1NR
Guys St Thomas Hospital
London, SE1 7EH
Kings College Hospital
London, SE5 9RS
St Georges University Hospital NHS Foundation Trust
London, SW17 0RE
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
Whiston Hospital
Prescot, L35 5DR
Southampton University Hospital
Southampton, SO16 6YD
Brazil8 sites
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, 18618-687
L2IP Instituto de Pesquisas Clinicas
Brasília, 70.200-730
CDC - Centro Digestivo de Curitiba
Curitiba, 80430-180
Hospital de Clinicas de Porto Alegre - Hospital de Clinicas
Porto Alegre, 90035 903
Pesquisare Saude
Santo André, 09080-110
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo, 01236030
Instituto D Or de Pesquisa e Ensino
São Paulo, 01401 002
INTEGRAL Pesquisa e Ensino
Votuporanga, 15501-405
Germany8 sites
Klinikum Augsburg
Augsburg, D-86158
Krankenhaus Waldfriede Mitte
Berlin, 14163
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
Medizinische Hochschule Hannover
Hanover, 30625
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105
Eugastro GmbH
Leipzig, 04103
Staedtisches Klinikum Lueneburg
Lüneburg, 21339
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423
Italy7 sites
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, 20122
Ospedale San Raffaele di Milano
Milan, 20132
Ospedale Sacro Cuore Don Calabria
Negrar, 37024
Azienda Ospedaliera San Camillo - Roma
Roma, 00152
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
Istituto Clinico Humanitas
Rozzano, 20089
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013
South Korea7 sites
Inje University Haeundae Paik Hospital
Busan, 48108
Yeungnam University Hospital
Daegu, 42415
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic university of Korea, St. Vincent's Hospital
Suwon, 16247
Belgium6 sites
CHU Saint-Pierre
Brussels, 1000
AZ Sint-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
Vitaz
Sint-Niklaas, 9100
Hungary6 sites
Semmelweis Egyetem
Budapest, 1083
Semmelweis Egyetem 1
Budapest, 1088
Pannónia Magánorvosi Centrum Kft
Budapest, H-1136
Vasutegeszsegugyi Nonprofit Kozhasznu Kft
Debrecen, 4025
Debreceni Egyetem Gasztroenterologiai Klinika
Debrecen, 4032
Clinexpert Kft
Gyöngyös, 3200
Argentina5 sites
Cer Instituto Medico
Buenos Aires, B1878DVB
CIPREC
Buenos Aires, C1061AAS
Gedyt - Consultorios Gastroenterologia
Buenos Aires, C1425
Hospital Provincial del Centenario
Rosario, S2000KDS
Sanatorio 9 de Julio
San Miguel de Tucumán, 4000
Canada5 sites
Barrie GI Associates
Barrie, Ontario, L4M 7G1
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2
London Health Sciences Centre
London, Ontario, N6A 5A5
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0C1
ABP Research Services Corp.
Oakville, Ontario, L6L 5L7
Czechia5 sites
Nemocnice Ceske Budejovice
České Budějovice, 370 01
Gastroenterologie, s.r.o., Hradec Kralove
Hradec Kralova, 500 02
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, 500 12
ISCARE a.s.
Prague, 19000
Nemocnice Slany
Slaný, 27401
Australia4 sites
Sunshine Coast University Hospital
Birtinya, 4575
Blacktown Hospital
Blacktown, 2148
Concord Repatriation General Hospital
Concord, 2139
Wollongong Private Hospital
Wollongong, 2500
India4 sites
S. R. Kalla Memorial General Hospital
Jaipur, 302006
Midas Hospital
Nagpur, 441108
Govind Ballabh Pant Hospital
New Delhi, 110002
SIDS Hospital & Research Centre
Surat, 395002
Romania4 sites
Spital Memorial
Bucharest, 013823
S C Delta Health Care S R L
Bucharest, 014146
Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
Cluj-Napoca, 400061
Centrul Medical Valahia
Ploieşti, 100032
Turkey (Türkiye)4 sites
Gazi University Medical Faculty
Ankara, 6500
Uludag Universitesi Tıp Fakultesi Hastanesi
Bursa, 16059
Ege Universitesi Tip Fakultesi
Izmir, 35040
Mersin University Medical Faculty
Mersin, 33343
Malaysia3 sites
Hospital Sultanah Aminah
Johor Bahru, 80100
Sultan Idris Shah Hospital
Kajang, 43000
University Malaya Medical Centre
Kuala Lumpur, 59100
About this study
Official title: A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
- Conditions
- Colitis, Ulcerative
- Being tested
- JNJ-77242113, 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.
JNJ-77242113Drug
JNJ-77242113 tablet will be administered orally.
PlaceboDrug
Placebo tablet will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: JNJ-77242113 Dose-1 | Experimental | Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76. Receives: Drug: JNJ-77242113 |
| Group 2: JNJ-77242113 Dose-2 | Experimental | Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76. Receives: Drug: JNJ-77242113 |
| Group 3: JNJ-77242113 Dose-3 | Experimental | Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76. Receives: Drug: JNJ-77242113 |
| Group 4: Placebo | Experimental | Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76. Receives: Drug: JNJ-77242113; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Clinical Response at Week 12
Clinical response is defined as 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: Week 12
Secondary outcomes (5)
Percentage of Participants with Clinical Remission at Week 12
Clinical remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Measured: Week 12
Percentage of Participants with Symptomatic Remission at Week 12
Symptomatic remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0.
Measured: Week 12
Percentage of Participants with Endoscopic Improvement at Week 12
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Measured: Week 12
Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12
Histologic-endoscopic mucosal improvement is defined as a combination of histologic remission and endoscopic improvement. Histologic remission and endoscopic improvement are based on the histologic grading and the Mayo endoscopy subscore.
Measured: Week 12
Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE 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 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start9 Oct 2023
- Primary completion26 Sep 2024
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049017
- Sponsor's protocol ID
- 77242113UCO2001
- Other IDs
- 77242113UCO2001, 2023-504673-20-00, 2023
- Acronym
- ANTHEM-UC
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2023
- Last updated
- 13 Apr 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 the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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
Publications
Abreu MT, Siegmund B, Surace L, Erondu N, Chen M, Chachu K, Louis E, Matsuoka K, Limdi J, Arthur E, Houck N, Marano C, Vetter ML, Zou B, Zhan J, Frustaci ME, Kannan AK, Rydzewska G, Loftus EV Jr, Jairath V; ANTHEM-UC Study Group. Phase 2 Trial of Icotrokinra for Patients with Ulcerative Colitis. N Engl J Med. 2026 Oct 15;395(15):1495-1504. doi: 10.1056/NEJMoa2604435.
PubMed 42874103
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06049017
- Acronym / sponsor ID
- ANTHEM-UC / 77242113UCO2001
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: JNJ-77242113 Dose-1 | Experimental | Drug: JNJ-77242113Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76. |
| Group 2: JNJ-77242113 Dose-2 | Experimental | Drug: JNJ-77242113Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76. |
| Group 3: JNJ-77242113 Dose-3 | Experimental | Drug: JNJ-77242113Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76. |
| Group 4: Placebo | Experimental | Drug: JNJ-77242113, Drug: PlaceboParticipants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent form 18 years of age or older
- Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
- Moderately to severely active UC as per the modified Mayo score
- Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Key exclusion criteria (6 listed)
- Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
- UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
- Presence of a stoma
- Presence or history of fistula
- History of extensive colonic resection (example, <30 cm of colon remaining)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-77242113JNJ-77242113 tablet will be administered orally. | Drug | Group 1: JNJ-77242113 Dose-1, Group 2: JNJ-77242113 Dose-2, Group 3: JNJ-77242113 Dose-3, Group 4: Placebo |
| PlaceboPlacebo tablet will be administered orally. | Drug | Group 4: Placebo |
Primary outcome
Percentage of Participants with Clinical Response at Week 12
Time frame: Week 12
Clinical response is defined as 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.
5 secondary outcomes
Percentage of Participants with Clinical Remission at Week 12
Time frame: Week 12
Percentage of Participants with Symptomatic Remission at Week 12
Time frame: Week 12
Percentage of Participants with Endoscopic Improvement at Week 12
Time frame: Week 12
Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12
Time frame: Week 12
Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)
Time frame: Up to Week 76
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42874103Abreu MT, Siegmund B, Surace L, Erondu N, Chen M, Chachu K, Louis E, Matsuoka K, Limdi J, Arthur E, Houck N, Marano C, Vetter ML, Zou B, Zhan J, Frustaci ME, Kannan AK, Rydzewska G, Loftus EV Jr, Jairath V; ANTHEM-UC Study Group. Phase 2 Trial of Icotrokinra for Patients with Ulcerative Colitis. N Engl J Med. 2026 Oct 15;395(15):1495-1504. doi: 10.1056/NEJMoa2604435.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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
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Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
177 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-77242113 in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 177 sites in 21 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 177 sites in United States, Japan, China, Poland, France and 16 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants with Clinical Response at Week 12 (time frame: Week 12). 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 NCT06049017, which also lists 1 linked publication.
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 13 Apr 2026.