A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: RO7837195Drug: RO7837195 Matched Placebo
- Registration Number
- NCT06979336
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 224
- Diagnosis of ulcerative colitis (UC) established at least 3 months
- Moderately to severely active UC assessed by mMS
- Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC
- Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
- Diagnosis of Crohn's disease or indeterminate colitis
- Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
- Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RO7837195 Dose Regimen 1 RO7837195 Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. RO7837195 Dose Regimen 2 RO7837195 Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. RO7837195 Dose Regimen 3 RO7837195 Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. RO7837195 Dose Regimen 4 RO7837195 Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. RO7837195 Matched Placebo/ RO7837195 RO7837195 Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively. RO7837195 Matched Placebo/ RO7837195 RO7837195 Matched Placebo Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Clinical Remission at Week 12 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Clinical Response at Week 12 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.
Percentage of Participants With Endoscopic Improvement at Week 12 At Week 12 Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1.
Percentage of Participants With Endoscopic Remission at Week 12 At Week 12 Endoscopic remission is defined as a Mayo endoscopy subscore of 0.
Number of Participants With Adverse Events (AEs) Up to Weeks 65 Serum Concentration of RO7837195 Up to Weeks 65 Percentage of Participants With Anti-drug Antibodies to RO7837195 Up to Weeks 65