Pediatric Moderate to Severe Ulcertative Colitis Study
A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib with Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
- Sex: Any
- Age: Child (Birth - 17)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Ulcerative Colitis
Study Purpose
The study objective is to assess efficacy, safety, and pharmacokinetics of upadacitinib in inducing and maintaining clinical remission in pediatric subjects 2 to 17 years of age with moderately to severely active UC, who have had an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
Who Can Participate
Age: 2-17 years old
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
- UH IRB: SITE00002046
- StudyID: 2023-01266
- ClinicalTrials.gov: NCT05782907
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