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A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease

NCT07298421•Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

May 29, 2026

Primary Completion Date

May 31, 2030

Completion Date

May 30, 2031

Last Updated

March 19, 2026

Enrollment

100

ESTIMATED participants

Conditions

Moderately to Severely Active Crohns Disease

Interventions

Afimkibart

DRUG

Contacts

Reference Study ID Number: CP45906 https://forpatients.roche.com/

CONTACT

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