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

NCT04064242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-04-13

Study results available
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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.

Conditions

  • Pulmonary Sarcoidosis

Interventions

DRUG

CMK389

single i.v. dose every 4 weeks

DRUG

Placebo

single i.v. dose every 4 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2023-09-19
Completion
2023-12-12
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Germany
  • Poland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04064242 on ClinicalTrials.gov