A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Part of paid clinical trials in Lancaster, California.

Sponsor
Genentech, Inc.
Study ID
NCT06979336
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7837195 — DRUG
    RO7837195 will be administered as per the schedule specified in the protocol.
  • RO7837195 Matched Placebo — DRUG
    RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Study Details

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.

Key Dates

Start date
Sep 29, 2025
Status verified
May 2026
Primary completion
Aug 25, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Percentage of Participants With Clinical Remission at Week 12 [ Time Frame: At Week 12 ]

Central Contacts

  • Reference Study ID Number: GA45977 https://forpatients.roche.com/
    888-662-6728 (U.S.)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (8)

FacilityCityStateZIPSite coordinators
Gastro Care InstituteLancasterCalifornia93534-
Medical Associates Research Group, Inc.San DiegoCalifornia92123-
Peak Gastroenterology AssociatesColorado SpringsColorado80907-
Clinical Research of Osceola, LLCKissimmeeFlorida34741-
University of Chicago Medical CenterChicagoIllinois60637-
Intercity GastroenterologyFresh MeadowsNew York11366-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
University of Utah Hospitals & ClinicsSalt Lake CityUtah84132-

Find similar trials in Lancaster, CA

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Gastro Care Institute· Lancaster, CAMedical Associates Research Group, Inc.· San Diego, CAPeak Gastroenterology Associates· Colorado Springs, COClinical Research of Osceola, LLC· Kissimmee, FLUniversity of Chicago Medical Center· Chicago, ILIntercity Gastroenterology· Fresh Meadows, NY

Related Studies