A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

Conditions

• Moderately to Severely Active Crohns Disease

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.

Study Details

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Key Dates

Start date

May 12, 2025

Status verified

Jun 2026

Primary completion

Dec 31, 2028

Completion

Apr 30, 2033

Study Design

Enrollment

425 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 afimkibart SC injection.

Primary Outcome Measure

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [ Time Frame: At Week 12 ]

Central Contacts

• Reference Study ID Number: GA45332 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 (50)

Find similar trials in Glendale, AZ

Related Studies

• A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
  PHASE3 · Recruiting · Hoffmann-La Roche · Dothan, Alabama