The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.
This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
RO7837195 will be administered as per the schedule specified in the protocol.
RO7837195 matched placebo will be administered as per the schedule specified in the protocol.
Percentage of Participants With Clinical Remission at Week 12
Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1.
Time frame: At Week 12
Percentage of Participants With Clinical Response at Week 12
Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1.
Time frame: At Week 12
Percentage of Participants With Endoscopic Improvement at Week 12
Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1.
Time frame: At Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Endoscopic remission is defined as a Mayo endoscopy subscore of 0.
Time frame: At Week 12
Number of Participants With Adverse Events (AEs)
Time frame: Up to Weeks 65
Serum Concentration of RO7837195
Time frame: Up to Weeks 65
Percentage of Participants With Anti-drug Antibodies to RO7837195
Time frame: Up to Weeks 65
Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below.
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