ANTHEM-UC
Research type
Research Study
Full 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
IRAS ID
1008443
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2023-504673-20
ISRCTN Number
ISRCTN15936332
Research summary
Ulcerative colitis (UC) is a chronic disease of large intestine (colon) in which lining of colon become inflamed and develop tiny open sore (ulcer).
JNJ-77242113 is an oral medicine that is designed to bind to IL-23 receptor and block IL-23* activity.
*IL-23 is specific type of protein involved in inflammation.
Aim of this study is to learn about effectiveness and safety of JNJ-77242113 for treatment of ulcerative colitis compared to placebo (any treatment that has no active properties).
Safety assessments may include physical examination, vital signs, electrocardiograms, laboratory assessments and adverse event.
Efficacy assessment will include UC disease evaluation (Mayo score histology, C-reactive protein, fecal calprotectin [a measure of inflammation in stool]) and patient reported outcomes.This study will include participants of 18 years and older with moderate to severe UC.
The study will include:
1. Screening period (up to 6 weeks)
2. Main treatment period (28 weeks) divided into 4 groups:
• Group 1: JNJ-77242113 Dose-1:
Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28.
• Group 2: JNJ-77242113 Dose-2:
Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28.
• Group 3: JNJ-77242113 Dose-3:
Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28.
• Group 4: Placebo:
Participants will receive placebo tablets orally from Week 0 through Week 28. Participants who receive placebo and experience an inadequate response will be switched to receive JNJ-77242113 Dose-3 tablets from Week 16 through Week 28.
3. Long term extension (LTE) period (48 weeks):
Participants who complete Week 28 assessment and are responding to treatment will continue the same treatment until Week 76 in LTE period.
4. Safety follow-up period (2 weeks after the last dose of study intervention)
Overall duration of study will be up to 84 weeks.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0306
Date of REC Opinion
1 Nov 2023
REC opinion
Further Information Favourable Opinion