A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT06049017

Run by

Janssen Research & Development, LLC

People needed

252

Starts

2023-10-09

Expected to finish

2026-01-05

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Universitair Ziekenhuis Leuven — Leuven, Belgium
• Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman — Liège, Belgium
• Vitaz — Sint-Niklaas, Belgium
• UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu — Botucatu, Brazil
• L2IP Instituto de Pesquisas Clinicas — Brasília, Brazil
• CDC - Centro Digestivo de Curitiba — Curitiba, Brazil
• Ospedale San Raffaele di Milano — Milan, Italy
• Ospedale Sacro Cuore Don Calabria — Negrar, Italy
• Azienda Ospedaliera San Camillo - Roma — Roma, Italy
• Fondazione Policlinico Universitario A Gemelli IRCCS — Roma, Italy
• Istituto Clinico Humanitas — Rozzano, Italy
• Casa Sollievo Della Sofferenza IRCCS — San Giovanni Rotondo, Italy
• Sai Gastroenterology Proctology — Fujiidera-shi, Japan
• Hamamatsu University Hospital — Hamamatsu, Japan
• Kagoshima IBD Gastroenterology Clinic — Kagoshima, Japan
• Tsujinaka Hospital Kashiwanoha — Kashiwa, Japan
• Aoyama Naika Clinic — Kobe, Japan
• Kinshukai Infusion Clinic — Osaka, Japan
• Japanese Red Cross Osaka Hospital — Osaka, Japan
• Clinnova Research — Anaheim, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• I.H.S. Health. LLC — Kissimmee, Florida, United States
• Ghent University Hospital — Ghent, Belgium

Full record on ClinicalTrials.gov

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