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

NCT07298421 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CP459062025-523318-96-00
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)

  At Week 52

• Percentage of Participants With Endoscopic Response

  At Week 52

Secondary Outcomes (12)

• Percentage of Participants With Clinical Remission

  At Week 12 and Week 52

• Percentage of Participants With Clinical Response

  At Week 12 and Week 52

• Percentage of Participants With CDAI Remission

  At Week 12 and Week 52

• Change From Baseline in Fecal Calprotectin

  Baseline, Week 12 and Week 52

• Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score

  Baseline, Week 12 and Week 52

Study Arms (2)

Afimkibart Dose A

EXPERIMENTAL

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

Drug: Afimkibart

Afimkibart Dose B

EXPERIMENTAL

Participants will receive Afimkibart IV followed by Afimkibart SC.

Drug: Afimkibart

Interventions

Afimkibart DRUG

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

Also known as: RO7790121, PF-06480605, RVT-3101

Afimkibart Dose A; Afimkibart Dose B

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 23, 2025
• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 30, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share