NCT04064242

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

A Subject and Investigator Blinded, Randomized, Placebo-controlled, Repeat-dose, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a subject and investigator blinded, randomized, placebo-controlled, parallel-group, repeat-dose, multicenter, non-confirmatory study of CMK389 in chronic pulmonary sarcoidosis. This study investigated the safety and efficacy of 10 mg/kg CMK389 administered intravenously (i.v.) every 4 weeks for a total of 4 doses, versus placebo

Conditions

• Pulmonary Sarcoidosis

Interventions

Type	Name	Description
DRUG	CMK389	single i.v. dose every 4 weeks
DRUG	Placebo	single i.v. dose every 4 weeks

Timeline

• Start date: 2020-09-23
• Primary completion: 2023-09-19
• Completion: 2023-12-12
• First posted: 2019-08-21
• Last updated: 2025-04-13
• Results posted: 2024-10-02

Locations

22 sites across 6 countries: United States, Czechia, Denmark, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study