drugset / Trial / NCT02775916
Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
RandomizedParallel-groupDouble-blindTreatment
Summary
This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173 in patients with primary Sjögren's syndrome.
Timeline
- Start
- 2016-06-01
- Primary completion
- 2017-05-17
- Completion
- 2017-05-17
Outcome
Missed primary endpoint
registry analysis (superiority test); CDZ173 vs Placebo; Mean Difference (Net) -0.69 (95% CI -3.343 to 1.937) NCT02775916 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leniolisib | Small molecule | — | Oral |