Trials / Terminated
TerminatedNCT03616821
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brazikumab | Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50 |
| DRUG | Placebo | Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning on Day 71 through Week 50. |
Timeline
- Start date
- 2018-08-07
- Primary completion
- 2023-10-23
- Completion
- 2023-10-23
- First posted
- 2018-08-06
- Last updated
- 2023-11-09
Locations
125 sites across 19 countries: United States, Canada, Czechia, Germany, Hungary, India, Israel, Italy, Japan, Poland, Puerto Rico, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03616821. Inclusion in this directory is not an endorsement.