Moderately to Severely Active Crohns Disease
Conditions
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).
Interventions
DRUGAfimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, Brazil, Mexico, South Africa, Taiwan, Thailand, United Kingdom, United States
Contacts
CONTACTReference Study ID Number: CP45906 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed