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Clinical Trials/NCT07298421
NCT07298421
Not yet recruiting
Phase 3

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

Hoffmann-La Roche0 sites100 target enrollmentStarted: May 29, 2026Last updated:
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InterventionsAfimkibart

Overview

Phase
Phase 3
Status
Not yet recruiting
Enrollment
100
Primary Endpoint
Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Afimkibart Dose A

Experimental

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

Intervention: Afimkibart (Drug)

Afimkibart Dose B

Experimental

Participants will receive Afimkibart IV followed by Afimkibart SC.

Intervention: Afimkibart (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Percentage of Participants With Endoscopic Remission(At Week 52)
  • Percentage of Participants With Corticosteroid-Free Clinical Remission(At Week 52)
  • Percentage of Participants with Maintenance of Remission(At Week 12 and Week 52)
  • Percentage of Participants With Histologic Improvement(At Week 52)
  • Percentage of Participants With Ulcer-Free Endoscopy(At Week 52)
  • Incidence and Severity of Adverse Events (AEs)(Up to Approximately 5.5 Years)
  • Serum Concentration of Afimkibart(Up to Approximately 5.5 Years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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