A Study to Assess the Efficacy, Safety, and what the body does to RO7837195 in Participants with Moderately to Severely Active Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genentech Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

4 Nov 2025 → ongoing

Decision date (initial)

2025-10-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Genentech Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy, Pharmacokinetic

To evaluate the efficacy of RO7837195 compared with placebo in inducing remission

Secondary objectives 4

1. To evaluate the efficacy of RO7837195 compared with placebo in inducing response
2. To evaluate the safety of RO7837195 compared with placebo
3. To characterize the pharmacokinetics of RO7837195
4. To evaluate the immunogenicity of RO7837195

Conditions and MedDRA coding

Moderately to Severely Active Ulcerative Colitis (UC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Diagnosis of UC established at least 3 months prior to screening, confirmed by clinical and endoscopic evidence during screening
2. Evidence of UC extending a minimum of 15 cm from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening
3. Colonoscopy within 2 years prior to screening or willingness to undergo colonoscopy in lieu of a flexible sigmoidoscopy at screening
4. Moderately to severely active UC, defined as a modified Mayo Score (mMS) of 5-9 including an endoscopic subscore of ≥ 2 during the screening period
5. Agreement to adhere to the contraception requirements
6. Prior advanced therapy failure and/or conventional therapy failure

Exclusion criteria 6

1. Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
2. Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
3. History of or current ileostomy or colostomy
4. Diagnosis of Crohn’s disease or indeterminate colitis
5. Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
6. Diagnosis of toxic megacolon within 12 months prior to screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical remission at Week 12, with clinical remission defined as mMS of ≤ 2, with Mayo subscores meeting the following criteria: – Stool frequency subscore ≤ 1 – Rectal bleeding subscore = 0 Endoscopy subscore ≤ 1 (score of 1 modified to exclude friability)

Secondary endpoints 8

1. Clinical response at Week 12, with clinical response defined as meeting both of the following sets of criteria: – Decrease from baseline in the mMS of ≥ 2 and ≥ 30% reduction from baseline - Decrease in Mayo rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤1
2. Endoscopic improvement at Week 12, with endoscopic improvement defined as a Mayo endoscopy subscore of ≤1 (score of 1 modified to exclude friability)
3. Endoscopic remission at Week 12, with endoscopic remission defined as a Mayo endoscopy subscore of 0
4. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) grading scale
5. Change from baseline in selected vital signs
6. Change from baseline in selected clinical laboratory test results
7. Serum concentration of RO7837195 at specified timepoints
8. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genentech Inc.

Sponsor organisation

Genentech Inc.

Address

1 Dna Way

City

South San Francisco

Postcode

94080-4918

Country

United States

Scientific contact point

Organisation

Genentech Inc.

Contact name

US Program Manager Product Development Regulatory

Public contact point

Organisation

Genentech Inc.

Contact name

US Program Manager Product Development Regulatory

Third parties 5

Locations

5 EU/EEA countries · 44 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications