CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
CMK389 +1 moredrug
Likely dose
CMK389 single IV dose every 4 weeksAI-extracted
Key inclusion· 7
  • ✓Biopsy-proven pulmonary sarcoidosis diagnosed >1 year prior to screening
  • ✓Scadding stage II, III, or IV on recent chest X-ray
  • ✓HRCT fibrosis extent <20%
  • ✓Currently treated with prednisone 5-15 mg/day for ≥6 months
Key exclusion· 10
  • ✕FVC <50% of predicted
  • ✕mMRC dyspnea scale ≥3
  • ✕Significant pulmonary hypertension (WHO group 5) requiring treatment
  • ✕Active cardiac sarcoidosis requiring treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04064242
NCT04064242Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Aug 21, 2019·Updated Apr 13, 2025

In Brief

A Phase 2 clinical trial evaluating CMK389 and Placebo for Pulmonary Sarcoidosis. Completed, enrolled 62 participants across 22 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Sarcoidosis
CountriesCzechia, Denmark, Germany, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 21, 2019
Enrollment StartSep 23, 2020
Primary CompletionSep 19, 2023
Study CompletionDec 12, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.9 years ago

Interventions

CMK389drug

single i.v. dose every 4 weeks

Placebodrug

single i.v. dose every 4 weeks