An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION]
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/21/2019 |
| Start Date: | August 7, 2018 |
| End Date: | February 14, 2021 |
| Contact: | Clinical Trials Registry Team |
| Email: | IR‐CTRegistration@Allergan.com |
| Phone: | 877‐277‐8566 |
A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
The present study (3151-201-008) seeks to evaluate the efficacy and safety of brazikumab
versus placebo in patients with moderately to severely active UC and will include assessments
of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal
appearance as observed on endoscopy.
versus placebo in patients with moderately to severely active UC and will include assessments
of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal
appearance as observed on endoscopy.
Inclusion Criteria:
- Diagnosis of UC for at least 3 months.
- Inadequate response or intolerance to conventional therapy for the treatment of
ulcerative colitis
- Evidence of active UC based on the modified Mayo score
- No known history of active TB
- Agree to practicing abstinence or adhering to specific birth control requirements
Exclusion Criteria:
- Participant has UC limited to the rectum
- History of fulminant colitis, a diagnosis of Crohn's disease or indeterminate colitis
specific complication of UC, including toxic megacolon
- Previous intolerance or non-response to vedolizumab
- Participants receiving exclusionary treatment within specified time periods
- History of cancer, except for basal cell carcinoma, squamous cell carcinoma, or
carcinoma in situ of the cervix.
- Clinically significant infections
- Clinically significant cardiovascular conditions
We found this trial at
46
sites
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