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.

Study Identifier
M14-658
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2022-501788-41-00
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
  • Study Drug
  • Upadacitinib
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    2 - 17 Years

    Protocol Summary

    Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed.

    Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-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 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 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 be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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.

    Study Locations

    Location
    Status
    Location
    Phoenix Children's Hospital /ID# 250135
    Phoenix, Arizona, United States, 85016-7710
    Status
    Not applicable
    Location
    Arkansas Children's Hospital /ID# 250106
    Little Rock, Arkansas, United States, 72202
    Status
    Not applicable
    Location
    Kindred Medical Institute - Corona /ID# 255484
    Corona, California, United States, 92879-3104
    Status
    Not applicable
    Location
    UCSF Benioff Children's Hospital - Oakland /ID# 255067
    Oakland, California, United States, 94609
    Status
    Not applicable
    Location
    Lucile Packard Children's Hospital /ID# 258430
    Palo Alto, California, United States, 94304
    Status
    Not applicable
    Location
    Children's Hospital Colorado - Aurora /ID# 250110
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
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