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ClinicalTrial.gov Identifier : NCT03345836

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

    Status Recruiting
    Related Conditions
    Crohn's Disease (CD)

Enrollment Details

855 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M14-431

Brief summary

Top

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 75 Years

Canada: 16

0
Calgary, AB
1
Edmonton, AB
2
Edmonton, AB
3
Edmonton, AB
4
New Westminster, BC
5
Vancouver, BC
6
Halifax, NS
7
North Bay, ON
8
Oshawa, ON
9
Sudbury, ON
10
Vaughan, ON
11
Greenfield Park, QC
12
Levis, QC
13
Montreal, QC
14
Montréal, QC
15
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 Blind (Subject / Caregiver / 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

    • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
    • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
    • Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
    • Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
    • If female, subject must meet the contraception recommendations
    • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
    • Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
    • Participant with the following known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
    • Participant with ostomy or ileoanal pouch
    • Participant diagnosed with short gut or short bowel syndrome
    • Screening laboratory and other analyses show abnormal results.

More on this trial

Clinical Trials.gov