A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 16 - 80 |
Updated: | 4/6/2019 |
Start Date: | December 18, 2017 |
End Date: | August 13, 2020 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus
placebo during induction therapy in subjects with moderately to severely active CD.
placebo during induction therapy in subjects with moderately to severely active CD.
Inclusion Criteria:
- Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
local regulations, at the Baseline Visit. Where locally permissible, subjects 16 to <
18 years of age who meet the definition of Tanner stage 5 for development at the
Baseline Visit
- 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, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
- Demonstrated intolerance or inadequate response to biologic therapy for CD
- If female, subject must meet the contraception recommendations
Exclusion Criteria:
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
- Subjects with unstable doses of concomitant Crohn's disease therapy
- Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
within 12 weeks prior to Baseline), or any investigational biologic or other agent or
procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is
longer.
- Prior exposure to p19 inhibitors (e.g., risankizumab).
- Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
- Having an ostomy or ileoanal pouch
We found this trial at
107
sites
1211 Medical Center Drive
Nashville, Tennessee 37212
Nashville, Tennessee 37212
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Kinston, North Carolina 28501
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800 Rose Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
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