A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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

Key facts

Study ID

NCT03345849

Run by

AbbVie

People needed

526

Starts

2017-12-07

Expected to finish

2022-01-13

Last updated by the study team

2022-11-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), in the opinion of the investigator.
• Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).
• If female, participant must meet the contraception recommendations.

You may not qualify 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 ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, 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 analyses show abnormal results.

Where it is running

• CB Flock Research Corporation /ID# 166185 — Mobile, Alabama, United States
• Delsol Research Management, Ll /Id# 170145 — Chandler, Arizona, United States
• HonorHealth Research Institute - Shea /ID# 164821 — Scottsdale, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803 — Sun City, Arizona, United States
• Southern California Res. Ctr. /ID# 169655 — Coronado, California, United States
• Citrus Valley Gastroenterology /ID# 166173 — Covina, California, United States
• Hoag Memorial Hosp Presbyterian /ID# 222540 — Irvine, California, United States
• United Medical Doctors /ID# 207449 — Los Alamitos, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762 — Los Angeles, California, United States
• Facey Medical Foundation /ID# 203136 — Mission Hills, California, United States
• United Medical Doctors - Murrieta /ID# 164945 — Murrieta, California, United States
• Ucsd /Id# 164910 — San Diego, California, United States
• Medical Assoc Research Grp /ID# 169706 — San Diego, California, United States
• Univ of California San Francis /ID# 164944 — San Francisco, California, United States
• Care Access Research /ID# 167767 — San Pablo, California, United States
• Peak Gastroenterology Associates, PC /ID# 170143 — Colorado Springs, Colorado, United States
• Delta Waves, Inc. /ID# 164776 — Colorado Springs, Colorado, United States
• Western States Clinical Res /ID# 164760 — Wheat Ridge, Colorado, United States
• Medical Research Center of CT /ID# 164926 — Hamden, Connecticut, United States
• Clinical Research of West Florida, Inc /ID# 205827 — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc /ID# 208118 — Clearwater, Florida, United States
• Advanced Research - Coral Springs /ID# 218021 — Coral Springs, Florida, United States
• Encore Borland-Groover Clinical Research /Id# 203499 — Jacksonville, Florida, United States
• Ctr for Advanced Gastroenterol /ID# 165353 — Maitland, Florida, United States
• East View Medical Research, LLC /ID# 171176 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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