Moderately to Severely Active Ulcerative Colitis
Conditions
Brief summary
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
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
* Bodyweight \>= 10 kilogram (kg) * Confirmed diagnosis of UC * Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy) * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol
Exclusion criteria
* Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD) * Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease * Presence of an ostomy or ileoanal pouch * Current diagnosis or suspicion of primary sclerosing cholangitis * Any major surgery within 6 weeks prior to screening or a major planned surgery during the study * Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Clinical Remission at Week 52 | At Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response | From Baseline, at Week 12 |
| Percentage of Participants With PUCAI Remission | At Week 12 |
| Change From Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores | From Baseline to Week 12 |
| Partial Modified Mayo Score (pmMS) | At Week 12 |
| Percentage of Participants With Symptomatic Response | At Week 12 |
| Percentage of Participants With Symptomatic Remission | At Week 12 |
| Change From Baseline in PUCAI Response at Week 52 | From Baseline, at Week 52 |
| Percentage of Participants With PUCAI Remission at Week 52 | At Week 52 |
| Change From Baseline in TUMMY-UC Scores | From Baseline to Week 52 |
| Percentage of Participants With Endoscopic Remission | At Week 52 |
| Percentage of Participants With Endoscopic Improvement | At Week 52 |
| Percentage of Participants With Histologic Improvement | At Week 52 |
| Percentage of Participants With Histologic-endoscopic Mucosal Improvement | At Week 52 |
| Percentage of Participants With Histologic-endoscopic Mucosal Remission | At Week 52 |
| Percentage of Participants With Clinical Remission Without the use of Corticosteroids | At Week 52 |
| Percentage of Participants With Adverse Events (AEs) | From Baseline up to approximately 4 years |
| Serum Concentration of Afimkibart | Up to approximately 4 years |
Countries
Australia, Brazil, Canada, China, South Africa, Taiwan, Thailand, United Kingdom, United States
Contacts
CONTACTReference Study ID Number: CA45905 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