A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

  • STATUS
    Recruiting
  • End date
    Mar 20, 2022
  • participants needed
    844
  • sponsor
    AbbVie
Updated on 26 October 2020
corticosteroids
remission
aminosalicylates

Summary

This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission in order to identify the induction dose of upadacitinib for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

Details
Treatment Placebo, ABT-494, Updacitinib (ABT-494)
Clinical Study IdentifierNCT02819635
SponsorAbbVie
Last Modified on26 October 2020

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Eligibility

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Inclusion Criteria

Is your age between 16 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Ulcerative Colitis or Ulcerative Colitis (Pediatric)?
Note: Adolescent participants at the age of 16 or 17 years old will be
eligible to participate if approved by the country or regulatory/health
authority. If approval has not been granted, only participants >= 18 years old
will be enrolled
Adolescents must weigh >= 40 kilograms and meet the definition of Tanner Stage
at Screening Visit
Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available
Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader)
Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator
Note: Participants who have had inadequate response, loss of response to
conventional therapy, but have not failed biologic therapy (Non-bio-IR) and
have received a prior biologic for up to 1 year may be enrolled, however they
must have discontinued the biologic for reasons other than inadequate response
or intolerance (e.g., change of insurance, well controlled disease) and must
meet criteria for inadequate response, loss of response or intolerance to
aminosalicylates, corticosteroids, and/or immunosuppressants as defined above
If female, participant must meet the criteria for Contraception Recommendations
Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing

Exclusion Criteria

Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)
Current diagnosis of fulminant colitis and/or toxic megacolon
Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy
Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
Participant on azathioprine or 6-mercaptopurine within 10 days of baseline
Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period
Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib)
Screening laboratory and other analyses show any abnormal results
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