A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
NCT ID: NCT06979336
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
224 participants
INTERVENTIONAL
2025-09-29
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
RO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
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.
RO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
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.
RO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
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.
RO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
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.
RO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
RO7837195 Matched Placebo
RO7837195 matched placebo will be administered as per the schedule specified in the protocol.
Interventions
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RO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
RO7837195 Matched Placebo
RO7837195 matched placebo will be administered as per the schedule specified in the protocol.
Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active UC assessed by mMS
* Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Gastro Care Institute
Lancaster, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Clinical Research of Osceola, LLC
Kissimmee, Florida, United States
Intercity Gastroenterology
Fresh Meadows, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
London Digestive Disease Institute
London, Ontario, Canada
PreventaMed, s.r.o.
Olomouc, , Czechia
Nemocnice Slany
Slaný, , Czechia
CHU Saint Etienne - Hpital Nord
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, Puy De Dome, France
Centre hospitalier Lyon Sud
Pierre-Bénite, Rhone, France
Clinsante S.C. Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Centrum Medyczne Lukamed Joanna Luka
Chojnice, , Poland
Vita Longa Sp. z o.o.
Katowice, , Poland
MZ Badania Slowik Zymla Sp.j.
Knurów, , Poland
SOLUMED Centrum Medyczne
Poznan, , Poland
NSZOZ Termedica Centrum Badan Klinicznych
Poznan, , Poland
Clinical Research Center Spka z ograniczon odpowiedzialnoci Medic-R Sp.k.
Poznan, , Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
Warsaw, , Poland
Provita Poliklinika sp. z o.o
Warsaw, , Poland
Medon Clinical Research sp. z o.o
Warsaw, , Poland
Przychodnia VISTAMED
Wroc?aw, , Poland
ETG Zamosc
Zamość, , Poland
King's College Hospital
London, Greater London, United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: GA45977 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2025-520690-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
GA45977
Identifier Type: -
Identifier Source: org_study_id
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