An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 16 - 80 |
Updated: | 4/3/2019 |
Start Date: | December 7, 2018 |
End Date: | December 4, 2022 |
Contact: | Clinical Trial Registry Team |
Email: | IR-CTRegistration@Allergan.com |
Phone: | 877-277-8566 |
A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I)
and versus an active comparator (Stage 2) in participants with moderately to severely active
CD and will include assessments of clinical response as demonstrated by improvement of
symptoms and colonic mucosal appearance as observed on endoscopy
and versus an active comparator (Stage 2) in participants with moderately to severely active
CD and will include assessments of clinical response as demonstrated by improvement of
symptoms and colonic mucosal appearance as observed on endoscopy
Inclusion and Exclusion Criteria are the same for both Stage 1 and Stage 2; however,
participants enrolled in Stage 1 will not be permitted to enroll in Stage 2.
Inclusion Criteria:
- Aged 16 to 80 years, inclusive, at Screening. For participants less than 18 years of
age, the participant must weigh at least 40 kg
- Diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum
of 3 months prior to screening
- Moderately to severely active Crohn's Disease
Exclusion Criteria:
- Participant is unable or unwilling to have endoscopic procedures performed during the
study.
- History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic
colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis,
or untreated bile acid malabsorption.
- Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma
within 3 months prior to screening.
- Participant has known history of drug (including opiates) or alcohol abuse.
- Currently enrolled in another investigational device or drug study.
- Participant is pregnant, breastfeeding, or plans to become pregnant during the study.
We found this trial at
39
sites
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