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Clinical trial

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

NCT05782907 is registered in ClinicalTrials.gov with AbbVie as lead sponsor.

NCT NCT05782907
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
AbbVie
Phase
Phase 3
Overall status
Active, not recruiting
Start date
November 6, 2023
Completion date
October 31, 2031
Enrollment
122 (actual)
Sites
89

Conditions

As the registry lists them; a condition with its own page is linked.

ulcerative colitis