Trials / Terminated
TerminatedNCT02405442
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 187 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Andecaliximab | Andecaliximab administered via subcutaneous (SC) injection |
| DRUG | Placebo | Placebo to match andecaliximab administered via SC injection |
Timeline
- Start date
- 2015-04-30
- Primary completion
- 2016-11-30
- Completion
- 2016-12-22
- First posted
- 2015-04-01
- Last updated
- 2019-04-23
- Results posted
- 2019-03-28
Locations
74 sites across 13 countries: United States, Australia, Canada, Czechia, France, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02405442. Inclusion in this directory is not an endorsement.