Recruiting
Phase 3

Afimkibart

Sponsor:

Hoffmann-La Roche

Code:

NCT07298421

Conditions

Moderately to Severely Active Crohns Disease

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Afimkibart

Study Details

Brief summary:

This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).

Conditions

Moderately to Severely Active Crohns Disease

Study ID

NCT07298421

Start date

Aug 18, 2026

Status verified date

Sep, 2026

Completion date

May 30, 2031

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Body weight >= 10 kilogram (kg)
  • Active CD confirmed by endoscopy (ileocolonoscopy)
  • Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score >= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) >=6 (or >=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy
  • Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)

Exclusion Criteria:

  • Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
  • History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
  • Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.
  • Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  • Presence of abdominal or perianal abscess
  • Current diagnosis or suspicion of primary sclerosing cholangitis

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afimkibart Dose A

Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.

experimental: Afimkibart Dose B

Participants will receive Afimkibart IV followed by Afimkibart SC.

Interventions

Afimkibart

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Primary outcome measure

  • Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI) [ Time Frame: At Week 52 ]
  • Percentage of Participants With Endoscopic Response [ Time Frame: At Week 52 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: CP45906 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-08.