Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis
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|ClinicalTrials.gov Identifier: NCT04064242|
Recruitment Status : Not yet recruiting
First Posted : August 21, 2019
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Sarcoidosis||Drug: CMK389 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be assigned to one of two treatment arms, either CMK389 or placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Estimated Study Start Date :||July 14, 2020|
|Estimated Primary Completion Date :||April 4, 2022|
|Estimated Study Completion Date :||April 4, 2022|
single i.v. dose every 4 weeks
Placebo Comparator: Placebo
single i.v. dose every 4 weeks
- Forced Vital Capacity [ Time Frame: Baseline to Week 16 ]Change in forced vital capacity, % of predicted, between CMK389 and placebo.
- Composite index of pulmonary physiology and exercise capacity [ Time Frame: Baseline to Week 16 ]Relative reduction in forced volume capacity ≥ 10% or relative reduction in forced expiratory volume in one second ≥ 10% or relative reduction of diffusion capacity ≥ 15% or relative reduction of 6-minute walk distance ≥ 50 meters.
- [18F]-fluorodeoxyglucose positron emission tomography/computed tomography [ Time Frame: Baseline to Week 16 ]Change in imaging maximum standardized uptake value and mean standardized uptake value.
- Pulmonary physiology [ Time Frame: Baseline to Week 16 ]Change in forced expiratory volume in one second and diffusion capacity for carbon monoxide.
- Steroid use (mg days) [ Time Frame: Baseline to Week 16 ]Difference in steroid usage for each arm of the study.
- Exercise capacity [ Time Frame: Baseline to Week 16 ]Change in 6-minute walk distance.
- Pharmacokinetics of CMK389 maximum concentration (Cmax) [ Time Frame: Day 1 through Week 28 ]The observed maximum plasma concentration (Cmax) following drug administration [mass / volume].
- Pharmacokinetics of CMK389 trough concentration (Ctrough) [ Time Frame: Day 1 through Week 28 ]The lowest concentration of drug (Ctrough) reached before the next dose is administered.
- Pharmacokinetics of CMK389 area under the curve (AUC) [ Time Frame: Day 1 through Week 28 ]Area under the plasma concentration-time curve (AUC) from time zero to where time is a defined time point after administration [mass x time / volume].
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064242
|Contact: Novartis Pharmaceuticals||1-888-669-6682||Novartis.firstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals||+41613241111|