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U-Accomplish

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

    Status Recruiting
    Related Conditions
    Ulcerative Colitis (UC)

Enrollment Details

462 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID
M14-675

Brief summary

Top

The objective of this study is to evaluate the efficacy and safety of Upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Participant Attributes :
  • Male and Female
  • Ages 16-75 years old

Canada: 8

0
Calgary, AB
1
Edmonton, AB
2
Edmonton, AB
3
Edmonton, AB
4
Victoria, BC
5
Vaughan, ON
6
Montreal, QC
7
Sherbrooke, QC
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Male or female participants >= 16 and <=75 years of age at Baseline

     

    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 authorities.

    Note: Adolescent participants at the age of 16 or 17 years old must weigh >=40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.

    • Diagnosis of Ulcerative Colitis (UC) 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 UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
    • Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.

     

    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 as defined above.

    • 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.
    • If female, participant must meet the contraception recommendation 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, or mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
    • Participant who received azathioprine or 6-mercaptopurine (6-MP) 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 prespecified abnormal hematologic results.