A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Conditions

• Moderately to Severely Active Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

16 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Afimkibart — DRUG
  Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
• Placebo — DRUG
  Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Study Details

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Key Dates

Start date

Dec 11, 2024

Status verified

Jun 2026

Primary completion

Jan 30, 2027

Completion

Jan 30, 2031

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Afimkibart
  Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
• Placebo Comparator: Placebo
  Participants will receive placebo IV followed by placebo SC.

Primary Outcome Measure

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

Central Contacts

• Reference Study ID Number: GA45330 https://forpatients.roche.com/
  888-662-6728 (U.S. and Canada)
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (71)

Find similar trials in Dothan, AL

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• A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
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