drugset / Trial / NCT04064242

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis

NCT04064242 ↗

Phase 2 Completed 62 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this proof of concept study was to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.

Timeline

Start
2020-09-23
Primary completion
2023-09-19
Completion
2023-12-12

Outcome

Missed primary endpoint

registry analysis (other test); CMK389 10 mg/kg i.v. vs Placebo i.v.; p = 0.1804; Posterior estimate treatment difference -1.49 (80% CI -3.56 to 0.60); Bayesian analysis NCT04064242 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CMK389 Unknown 10 mg/kg Intravenous

Indications