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

Purpose

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

Condition

  • Crohn's Disease

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, participant 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 ongoing 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 conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome. - Screening laboratory and other protocol pre-specified 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
Placebo Comparator
Part 1 (Double-blind): Placebo
Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
  • Drug: Matching Placebo for Upadacitinib
    Matching placebo tablets
Experimental
Part 1 (Double-blind): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
  • Drug: Upadacitinib
    Upadacitinib tablets
    Other names:
    • ABT-494
    • RINVOQ®
Experimental
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
  • Drug: Upadacitinib
    Upadacitinib tablets
    Other names:
    • ABT-494
    • RINVOQ®
Experimental
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
  • Drug: Upadacitinib
    Upadacitinib tablets
    Other names:
    • ABT-494
    • RINVOQ®
Experimental
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
  • Drug: Upadacitinib
    Upadacitinib tablets
    Other names:
    • ABT-494
    • RINVOQ®
Experimental
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
  • Drug: Upadacitinib
    Upadacitinib tablets
    Other names:
    • ABT-494
    • RINVOQ®

More Details

Status
Completed
Sponsor
AbbVie

Study Contact