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

a study on Crohn's Disease Inflammatory Bowel Disease Immunotherapy

Summary

for people ages 18-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Melvin Heyman

Description

Summary

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).

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction 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

Keywords

Crohn's Disease Upadacitinib Efficacy Safety Crohn Disease

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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.

Locations

  • UCSF Center for Colitis and Crohn's Disease /ID# 202373 accepting new patients
    San Francisco California 94115-3011 United States
  • Univ of California San Francis /ID# 164843 accepting new patients
    San Francisco California 94158 United States

Lead Scientist

  • Melvin Heyman
    Professor, Pediatrics. Authored (or co-authored) 302 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03345836
Phase
Phase 3
Study Type
Interventional
Last Updated