A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT07158242
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2026-03-31
2031-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Afimkibart Dose A
Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Afimkibart Dose B
Participants will receive Afimkibart IV followed by Afimkibart SC.
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Interventions
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Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of UC
* 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
* 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)
2 Years
17 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Central Contacts
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Reference Study ID Number: CA45905 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
Other Identifiers
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2025-522518-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
CA45905
Identifier Type: -
Identifier Source: org_study_id