Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease - Trial NCT06332534

Timeline & Enrollment

Primary Outcome

Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64,Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12.,Number of Participants with Adverse Events

Summary

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness,
 swelling), in the digestive tract, most often affecting the bowels. It can cause many
 different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study
 will assess how safe and effective oral Upadacitinib is in treating moderately to severely
 active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had
 inadequate response, loss of response, intolerance, or medical contraindications to
 corticosteroids, immunosuppressants, and/or biologic therapy.
 
 Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is
 being developed for moderate- to severely active CD in pediatric participants. This study is
 conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction
 phase which means that the study doctor and participants know that participants will receive
 UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind
 maintenance phase meaning that neither the participants nor the study doctors will know which
 dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label
 extension of Period 1. Approximately 110 pediatric participants with moderate to severely
 active CD will be enrolled at approximately 92 sites worldwide.
 
 Participants will receive upadacitinib oral tablets once daily or oral solution twice daily
 at approximately the same time each day, with or without food. Participants will have a
 safety follow up for 30 days after discontinuation from any time point within the study.
 
 There may be higher treatment burden for participants in this trial compared to their
 standard of care (due to study procedures). Participants will attend regular (weekly,
 monthly) visits during the study at a hospital or clinic. The effect of the treatment will be
 checked by medical assessments, blood tests, checking for side effects and completing
 questionnaires.

ICD-10 Classifications