Trials / Terminated
TerminatedNCT02843659
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Subjects With Moderate to Severe Primary Sjögren's Syndrome
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-931699 | Specified dose on specified days |
| DRUG | BMS-986142 | Specified dose on specified days |
| DRUG | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2016-10-18
- Primary completion
- 2017-07-24
- Completion
- 2017-07-24
- First posted
- 2016-07-26
- Last updated
- 2018-10-04
- Results posted
- 2018-10-04
Locations
34 sites across 11 countries: United States, Australia, Chile, Colombia, Italy, Mexico, Peru, Poland, Puerto Rico, Russia, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02843659. Inclusion in this directory is not an endorsement.