Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Upadacitinib, RINVOQ, Ulcerative Colitis, UC, Corticosteroids, Immunosuppressants, Biologic Therapy
Eligibility Criteria
Inclusion Criteria: Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to 3. Demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Exclusion Criteria: Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib). Females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
Sites / Locations
- UH Cleveland Medical Center /ID# 250134Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Period 1- Open Label Induction Phase
Period 1- Double Blind Maintenance Phase
Period 2- Open Label Long Term Extension Phase Arm A
Period 2- Open Label Long Term Extension Phase Arm B
Period 2- Long Term Extension Phase Arm C
All participants in open label induction phase of Period 1 will receive upadacitinib Dose A for 8 weeks based on body weight.
Clinical responders at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose B or Dose C for 44 weeks based on body weight.
Clinical non-responders outside of US after Period 1 induction phase will receive upadacitinib Dose A daily for 8 week extended induction phase in open label long term extension (OLE) Period 2. Clinical responders from extended induction phase in OLE will receive upadacitinib Dose B daily for up to 252 weeks in OLE period 2.
Clinical non-responders in US after Period 1 induction phase or clinical responders with loss of response during maintenance phase will receive upadacitinib Dose B daily for up to 260 weeks in OLE Period 2.
Clinical responders who complete Period 1 through Week 52 will receive upadacitinib Dose C daily for up to 260 weeks in OLE Period 2.