drugset / Trial / NCT02775916

Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome

NCT02775916 ↗

Phase 2 Completed 30 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Leniolisib Small molecule — Oral

Indications