Condition: Crohn's Disease · Sponsor: AbbVie
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 approx…
This description comes directly from the study's public registry record.
ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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| UCSF Benioff Children's Hospital - Oakland /ID# 262217 | Oakland, California, United States | Recruiting |
| Lucile Packard Children's Hospital /ID# 262193 | Palo Alto, California, United States | Recruiting |
| Children's Hospital Colorado - Aurora /ID# 262207 | Aurora, Colorado, United States | Recruiting |
| Connecticut Children's Medical Center - Hartford /ID# 262256 | Hartford, Connecticut, United States | Recruiting |
| OSF St. Francis Medical Center /ID# 262192 | Peoria, Illinois, United States | Recruiting |
| Indiana University Health Riley Hospital for Children /ID# 262215 | Indianapolis, Indiana, United States | Recruiting |
| Boston Children's Hospital /ID# 262191 | Boston, Massachusetts, United States | Recruiting |
| MNGI Digestive Health, P. A. /ID# 262204 | Minneapolis, Minnesota, United States | Recruiting |
| Icahn School of Medicine at Mount Sinai /ID# 262216 | New York, New York, United States | Recruiting |
| Univ NC Chapel Hill /ID# 262198 | Chapel Hill, North Carolina, United States | Recruiting |
| UH Cleveland Medical Center /ID# 262188 | Cleveland, Ohio, United States | Recruiting |
| Children's Hospital of Philadelphia - Main /ID# 262197 | Philadelphia, Pennsylvania, United States | Recruiting |
+ 73 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06332534