drugset / Trial / NCT02334306
A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
RandomizedParallel-groupTriple-blindTreatment
Summary
A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
Timeline
- Start
- 2015-06-08
- Primary completion
- 2018-01-16
- Completion
- 2018-08-13
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs MEDI5872 210 mg; p = 0.262; Mean Difference (Net) -1.4 (90% CI -3.6 to 0.7); ANCOVA NCT02334306 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMG 557 | Monoclonal antibody | 210 mg | Subcutaneous |