Clinical Trials in Mexico / NCT07298421
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 Mexico tracker
Condition(s) studied
Moderately to Severely Active Crohns Disease
Investigational drug(s) / intervention(s)
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
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 (17)
| Facility | City | Region | Status |
|---|---|---|---|
| NYU Langone Health | New York | New York | 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 |
| King's College Hospital | London | United Kingdom | Recruiting |
| Sheffield Childrens Hospital | Sheffield | United Kingdom | Recruiting |
More Hoffmann-La Roche trials in Mexico
Other trials for the same condition
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 Mexico