A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy 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
  Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
• Placebo — DRUG
  Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Study Details

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

Key Dates

Start date

Sep 17, 2024

Status verified

Mar 2026

Primary completion

Jan 30, 2027

Completion

Jan 30, 2031

Study Design

Enrollment

400 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 at Week 12 [ Time Frame: At Week 12 ]

Locations (79)

Find similar trials in Dothan, AL

Related Studies

• 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
  PHASE3 · Recruiting · Hoffmann-La Roche · Dothan, Alabama
• A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
  PHASE3 · Recruiting · Hoffmann-La Roche · Atlanta, Georgia