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Taking people in ItalyPhase 2

Tests RO7837195 against placebo in moderate to severe ulcerative colitis

Tests RO7837195 against placebo in adults with active ulcerative colitis.

Key facts

Who runs it
Genentech, Inc.
Where
Brescia, Milan, Negrar, Pavia, Rho, Rome, Rozzano, San Donato Milanese, and Turin, ItalySee the 9 sitesAlso in 14 other countries, 109 sites
Registry title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Status
Recruiting
Phase
Phase 2
People taking part
224 people, planned
Started
29 Sept 2025
Expected to end
31 Oct 2028
Type of study
Interventional, 5 groups
Treatments tested
  • RO7837195
  • RO7837195 Matched Placebo
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately to severely active ulcerative colitis. Earlier treatment with standard or advanced therapies must not have worked well enough.

Age
18 years or older
Sex
All sexes can join
Disease stage
Moderately to severely active ulcerative colitis (assessed by mMS), diagnosed at least 3 months ago
Earlier treatment
Earlier treatment with conventional or advanced therapies for UC did not work well enough, stopped working, or was not tolerated

Main reasons for not taking part

  • Prior extensive colon surgery, subtotal or total colectomy, or planned UC surgery
  • Crohn's disease or indeterminate colitis
  • Earlier treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
  • Treatment with an advanced therapy targeted at IL-12 and/or IL-23 that did not work well enough, stopped working, or was not tolerated

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

Also in 14 other countries, 109 sites

  • 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

About the trial

What the trial wants to find out

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.

The 5 groups in the trial

  • RO7837195 Dose Regimen 1Treatment being tested

    Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

    Treatment: RO7837195

  • RO7837195 Dose Regimen 2Treatment being tested

    Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

    Treatment: RO7837195

  • RO7837195 Dose Regimen 3Treatment being tested

    Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

    Treatment: RO7837195

  • RO7837195 Dose Regimen 4Treatment being tested

    Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

    Treatment: RO7837195

  • RO7837195 Matched Placebo/ RO7837195Treatment being tested

    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.

    Treatment: RO7837195 and RO7837195 Matched Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests RO7837195 against placebo in moderate to severe ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 October 2026