Ulcerative Colitis
RO7837195 Phase 2 Study for Moderately to Severely Active Ulcerative Colitis
This study compares RO7837195 with placebo in adults with moderately to severely active ulcerative colitis whose prior conventional or advanced treatment did not work adequately or was not tolerated.
Registry title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
8 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- RO7837195 or RO7837195 Matched Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below.888-662-6728 (U.S.)global-roche-genentech-trials@gene.com
- Sponsor
- Genentech, Inc.
Research question
Does RO7837195 produce clinical remission more often than placebo after 12 weeks in people with moderately to severely active ulcerative colitis whose prior therapy failed?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older.
- The study is looking for people whose ulcerative colitis diagnosis was established at least 3 months ago.
- The study is looking for people with moderately to severely active ulcerative colitis as assessed by the modified Mayo Score.
- The study is looking for people whose ulcerative colitis responded inadequately, stopped responding, or was not tolerated during conventional or advanced therapy.
Participation overview
What participation may involve
Participation may include up to 5 weeks of screening, 12 weeks of induction treatment, a 40-week active-treatment extension, and safety follow-up after the final dose. What participation may involve: - Participants receive a predefined regimen of RO7837195 or matched placebo during the 12-week induction phase. - After induction, all participants receive active RO7837195 during the 40-week extension, regardless of their treatment response. - The study assesses ulcerative colitis symptoms and endoscopic findings at Week 12 using components of the modified Mayo Score. - Safety events, blood levels of RO7837195, and antibodies against RO7837195 are assessed for up to 65 weeks. The reported treatment periods total 52 weeks after screening, followed by a safety follow-up period whose length is not stated.
Study interventions
What participants may receive or do
- RO7837195: RO7837195 is the study drug. Four groups receive different predefined dose regimens during the 12-week induction phase and the 40-week active-treatment extension; the placebo group switches to RO7837195 for the extension.
- RO7837195 Matched Placebo: This placebo is matched to RO7837195 and is given according to the protocol schedule during the 12-week induction phase in one study group.
Study design
How the comparison works
This is a randomized, parallel-group Phase 2 study. The first 12 weeks compare four RO7837195 dosing regimens with matched placebo; afterward, all participants receive active study drug during a 40-week extension. Participants are assigned randomly to parallel study groups, but the registry does not report the assignment ratios. During the masked portion, participants, care providers, investigators, and outcome assessors are blinded to treatment assignment. The 12-week induction phase uses a placebo control. After induction, all participants receive active RO7837195 regardless of treatment response. One listed group receives matched placebo during induction and then RO7837195 during the active-treatment extension. The registry does not state an individual's probability of assignment to that group.
Reported activities
Procedures and tests
- Screening may include confirmation that ulcerative colitis was diagnosed at least 3 months earlier and is moderately to severely active by the modified Mayo Score.
- The modified Mayo Score assessment includes stool-frequency, rectal-bleeding, and endoscopy subscores.
- Endoscopic improvement and endoscopic remission are assessed at Week 12.
- Adverse events are monitored for up to 65 weeks.
- Blood testing is used to measure the serum concentration of RO7837195 for up to 65 weeks.
- Testing assesses whether participants develop anti-drug antibodies to RO7837195 for up to 65 weeks.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Ulcerative colitis must have been diagnosed at least 3 months ago.
- Ulcerative colitis must be moderately to severely active when assessed using the modified Mayo Score.
- A conventional or advanced ulcerative colitis therapy must have produced an inadequate response, lost its effect, or been intolerable.
- Participants must be at least 18 years old.
Possible reasons someone may not be able to join
- People are excluded if they previously had an extensive colon resection or a subtotal or total colectomy, or if ulcerative colitis surgery is planned.
- People diagnosed with Crohn's disease or indeterminate colitis are excluded.
- Prior treatment with an advanced therapy targeting tumor necrosis factor-like cytokine 1A (TL1A) is exclusionary.
- People are excluded if an advanced therapy targeting interleukin-12 and/or interleukin-23 produced an inadequate response, lost its effect, or was not tolerated.
Important unknowns
What the record does not make clear
- The registry describes the study phases but does not state how many in-person or remote visits are required or when they occur.
- The registry reports up to 5 weeks of screening, 52 weeks of treatment, and a safety follow-up period, but it does not give the follow-up period's length.
- Five study groups are listed, including one placebo-then-RO7837195 group, but the assignment ratios are not reported.
- The registry does not state which current ulcerative colitis medicines may continue during the study.
- The registry does not provide washout requirements or timing rules for prior ulcerative colitis therapies.
- The registry does not describe permitted rescue treatment or what happens if ulcerative colitis worsens.
- Endoscopic outcomes are assessed at Week 12, but the registry does not provide the full endoscopy schedule or preparation requirements.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants are compensated.
- The registry does not state whether transportation, lodging, meals, or other travel support is available.
- The registry does not state whether RO7837195 may be available after study participation ends.
- The overall study and listed sites are marked recruiting, but availability for a particular person or dosing group must be confirmed with the selected site.
Before contacting the site
Questions for the study team
- What are the exact RO7837195 dose levels, dosing method, and dosing schedule for each study group?
- What is the chance of receiving placebo during the 12-week induction phase?
- How many visits and endoscopies are required, and which visits must occur at the study site?
- Which current ulcerative colitis treatments can continue, and are any medication washout periods required?
- What happens if ulcerative colitis symptoms worsen during induction or extension, and what rescue treatment is allowed?
- How long is safety follow-up after the last dose, and what assessments occur during it?
- Which study-related costs are covered, and are compensation or travel reimbursements available?
- Is the nearest listed site currently enrolling, and which treatment groups are open there?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what risks could arise if my current treatment must change for screening or study participation?
- What approved treatment alternatives are reasonable for me to consider alongside learning about this study?
- Does my prior treatment history include a TL1A-targeted therapy or an unsuccessful IL-12 and/or IL-23-targeted therapy that the study lists as exclusionary?
- How should my gastroenterology team and the research team coordinate symptom monitoring, endoscopies, routine care, and treatment decisions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 design and administration
- Organization
- Genentech, Inc.
- Organization class
- Industry
- Organization study ID
- GA45977
- Lead sponsor
- Genentech, Inc.
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
RO7837195 Dose Regimen 1
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Interventions: Drug: RO7837195
Experimental
RO7837195 Dose Regimen 2
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Interventions: Drug: RO7837195
Experimental
RO7837195 Dose Regimen 3
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Interventions: Drug: RO7837195
Experimental
RO7837195 Dose Regimen 4
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Interventions: Drug: RO7837195
Experimental
RO7837195 Matched Placebo/ 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.
Interventions: Drug: RO7837195, Drug: RO7837195 Matched Placebo
Interventions
Drug
RO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
Drug
RO7837195 Matched Placebo
RO7837195 matched placebo will be administered as per the schedule specified in the protocol.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (3)
- Diagnosis of ulcerative colitis (UC) established at least 3 monthsRegistry-derived · unreviewed
- Moderately to severely active UC assessed by mMSRegistry-derived · unreviewed
- Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UCRegistry-derived · unreviewed
Exclusion criteria (4)
- Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UCRegistry-derived · unreviewed
- Diagnosis of Crohn's disease or indeterminate colitisRegistry-derived · unreviewed
- Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)Registry-derived · unreviewed
- Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants With Clinical Remission at Week 12
Time frame: 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
Percentage of Participants With Clinical Response at Week 12
Time frame: 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.
Secondary outcome
Percentage of Participants With Endoscopic Improvement at Week 12
Time frame: At Week 12
Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1.
Secondary outcome
Percentage of Participants With Endoscopic Remission at Week 12
Time frame: At Week 12
Endoscopic remission is defined as a Mayo endoscopy subscore of 0.
Secondary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to Weeks 65
Secondary outcome
Serum Concentration of RO7837195
Time frame: Up to Weeks 65
Secondary outcome
Percentage of Participants With Anti-drug Antibodies to RO7837195
Time frame: Up to Weeks 65
Recruiting locations in the United States
Gastro Care Institute
RecruitingLancaster, California, 93534, United States
Medical Associates Research Group, Inc.
RecruitingSan Diego, California, 92123, United States
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
Clinical Research of Osceola, LLC
RecruitingKissimmee, Florida, 34741, United States
University of Chicago Medical Center
RecruitingChicago, Illinois, 60637, United States
Intercity Gastroenterology
RecruitingFresh Meadows, New York, 11366, United States
Monroe Biomedical Research
RecruitingMonroe, North Carolina, 28112, United States
University of Utah Hospitals & Clinics
RecruitingSalt Lake City, Utah, 84132, United States
This study also lists 95 locations outside the United States. They are not shown here.
Central study contacts
Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below.
Contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Registry dates
- First posted
- May 18, 2025
- Primary completion
- Aug 25, 2027
- Overall completion
- Oct 31, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.