Tests RO7837195 against placebo in moderate to severe ulcerative colitis
Tests RO7837195 against placebo in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Key facts
- Where
- Brescia, Milan, Negrar, Pavia, Rho, Rome, Rozzano, San Donato Milanese, and Turin, ItalySee the 9 sites
- Phase
- Phase 2
Where in Italy
- Fondazione PoliambulanzaBrescia, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- IRCCS Ospedale Sacro Cuore Don CalabriaNegrar, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda Socio Sanitaria Territoriale RhodenseRho, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Policlinico San Donato S.p.A.San Donato Milanese, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech, Inc.
- Trial code
- NCT06979336EU 2025-520690-39-00
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis
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.
Inclusion: 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: Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC; 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; Diagnosis of Crohn's disease or indeterminate colitis.