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
Recruiting · NCT07298421 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
14 locations listed across 1 US state.
- NYU Langone Health - New York, New York, United States
- Chulalongkorn University - Bangkok, Thailand
- Siriraj Hospital - Bangkok, Thailand
- Ramathibodi Hospital - Bangkok, Thailand
- IATROS International - Bloemfontein, South Africa
- Sheffield Childrens Hospital - Sheffield, United Kingdom
- National Taiwan University Hospital - Taipei, Taiwan
- FAICIC Clinical Research - Veracruz, Mexico
- Emmed Research - Pretoria, Gauteng, South Africa
- Centro de Investigación Clínica Acelerada, S.C - Mexico City, Mexico CITY (federal District), Mexico
- CECIP - Centro de Estudos Clínicos do Interior Paulista - Jaú, São Paulo, Brazil
- BR Trials - Pesquisa Clínica - São Paulo, São Paulo, Brazil
- Royal Children's Hospital - Parkville, Victoria, Australia
- Perth Children's Hospital - Nedlands, Western Australia, Australia