A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional Therapies But Have Not Failed Biologic Therapy
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/6/2019 |
Start Date: | December 7, 2017 |
End Date: | April 21, 2021 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
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 Conventional Therapies But Have Not Failed Biologic Therapy
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).
to placebo as induction therapy in participants with moderately and severely active Crohn's
disease (CD).
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 conventional therapies (Oral
locally acting steroids, Intravenous or oral corticosteroids, Immunosuppressants), in
the opinion of the investigator.
Note: Participants 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, 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.
We found this trial at
115
sites
1211 Medical Center Drive
Nashville, Tennessee 37212
Nashville, Tennessee 37212
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3205 Fire Road
Egg Harbor Township, New Jersey 08234
Egg Harbor Township, New Jersey 08234
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1401 Professional Boulevard
Evansville, Indiana 47714
Evansville, Indiana 47714
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