Ulcerative Colitis
Conditions
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.
Interventions
DRUGRO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
DRUGRO7837195 Matched Placebo
RO7837195 matched placebo will be administered as per the schedule specified in the protocol.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Australia, Brazil, Canada, China, Czechia, France, Germany, India, Italy, Japan, Mexico, Poland, South Korea, United Kingdom, United States
Contacts
CONTACTReference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed