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Recruiting Phase 3

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 · tracked via the Priya Life Science Brazil tracker
Phase
Phase 3
Started
2026-08-18
Last updated
2026-11-05

Condition(s) studied

Moderately to Severely Active Crohns Disease

Investigational drug(s) / intervention(s)

Afimkibart →

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

Study 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

Sex
ALL
Min age
2 Years
Max age
17 Years
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

Primary outcome measure(s)

  • 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

Trial sites (19)

FacilityCityRegionStatus
NYU Langone Health New York New York Recruiting
Texas Digestive Specialists Harlingen Texas Recruiting
Mater Hospital Brisbane South Brisbane Queensland Recruiting
Royal Children's Hospital Parkville Victoria Recruiting
Perth Children's Hospital Nedlands Western Australia Recruiting
Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista Jaú São Paulo Recruiting
BR Trials - Pesquisa Clínica São Paulo São Paulo Recruiting
Centro de Investigación Clínica Acelerada, S.C Mexico City Mexico CITY (federal District) Recruiting
FAICIC Clinical Research Veracruz Mexico Recruiting
Emmed Research Pretoria Gauteng Recruiting
IATROS International Bloemfontein South Africa Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
Chulalongkorn University Bangkok Thailand Recruiting
Siriraj Hospital Bangkok Thailand Recruiting
Ramathibodi Hospital Bangkok Thailand Recruiting
Birmingham Children's Hospital Birmingham United Kingdom Recruiting
King's College Hospital London United Kingdom Recruiting
Sheffield Childrens Hospital Sheffield United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07298421 on ClinicalTrials.gov ↗ ← All trials in Brazil