Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm B
Participants will receive placebo for 12 weeks.
  • Other: Matching placebo for upadacitinib
    Tablet
Other
Arm C
Participants will receive open-label upadacitinib dose A for 12 weeks.
  • Drug: upadacitinib
    Tablet
    Other names:
    • ABT-494
Experimental
Arm A
Participants will receive upadacitinib dose A for 12 weeks.
  • Drug: upadacitinib
    Tablet
    Other names:
    • ABT-494

Recruiting Locations

Montefiore Medical Center /ID# 166226
Bronx, New York 10461

More Details

NCT ID
NCT03345836
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
847.283.8955
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.