A Phase 2 interventional study of CMK389 and Placebo in Pulmonary Sarcoidosis, sponsored by Novartis Pharmaceuticals. Completed at 22 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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
63 studies on the registry are indexed under Sarcoidosis, Pulmonary; 15 are open to participants now.
This study's enrollment of 62 is above the median of 53 across 48 interventional studies indexed under Sarcoidosis, Pulmonary.
Browse Sarcoidosis, Pulmonary studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses
Drug: CMK389
Placebo i.v. every 4 weeks for a total of 4 doses
Drug: Placebo
single i.v. dose every 4 weeks
single i.v. dose every 4 weeks
Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment
To assess the effect of CMK389 compared to placebo after 16 weeks of treatment on spirometry (Forced Vital Capacity). Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Percent predicted FVC is the percentage of the age, height and gender adjusted predicted value.
Time frame: Baseline, Week 16
Number of Participants Who Had an Increase in Steroid Usage From Baseline to 16 Weeks of Treatment
The Clinical Status Evaluation (CSE) served as a safety evaluation and served to establish the patient's clinical status (Clinical Status Determination \[CSD\]). CSE was performed prior to the titration of steroids, and the CSD guided selection of the next dose of steroids. Participants with CSD of "improved" or "stable" decreased steroid dose by 1 step on the dosing scale. Participants with CSD of "deteriorating" were ineligible to continue the study (if found during the run-in epoch or at study Day 1); or they increased steroid dose by 1 step (if found during the treatment epoch).
Time frame: Baseline, Week 16
Number of Participants Who Deteriorate From Baseline to 16 Weeks of Treatment
Composite index of pulmonary physiology (CIPP) and exercise capacity: a participant who deteriorated from baseline to each visit was defined as a patient with: relative reduction if FVC ≥ 10%, or relative reduction if FEV1 ≥ 10%, or relative reduction of DLCO ≥ 15%, or relative reduction of 6MWD ≥ 50 m.
Time frame: Baseline, Week 16
Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment
\[18F\]-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) maximum standardized uptake value and mean standardized uptake value (SUVmax and SUVmean) imaging was used to assess potential anti-inflammatory effects by CMK389 on the sarcoidosis process. All participants underwent whole-body head to mid-thigh \[18F\]FDG-PET/CT imaging state-of-the-art, 3D PET/CT scanners with a reconstructed resolution of ≤5 mm.
Time frame: Baseline, Week 16
The Observed Serum Concentration Following CMK389 Administration at End of Infusion
Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis.
Time frame: Post 1 hour: Day 1, Day 29, Day 57, Day 85
Pre-dose Trough Concentration (Ctrough) of CMK389
Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Ctrough is the observed plasma concentration that is just prior to the beginning of a dosing interval.
Time frame: Pre-dose: Day 1, Day 29, Day 57, Day 85
Change in FEV1 From Baseline to 16 Weeks of Treatment
FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The least-squares means for change from baseline in FEV1 to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in pre-dose FEV1 is considered a favourable outcome.
Time frame: Baseline, Week 16
Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks of Treatment
DLCO is a measurement to assess the lungs' ability to transfer gas from inspired air to the bloodstream. The least squares means for change from baseline in DLCO to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in DLCO is considered a favourable outcome.
Time frame: Baseline, Week 16
Change in 6-minute Walk Distance (6MWD) From Baseline to 16 Weeks of Treatment
The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters. The least squares means for change from baseline in 6MWD to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in 6MWD is considered a favourable outcome.
Time frame: Baseline, Week 16
Participants took part in 22 investigative sites in 6 countries.
| Milestone | CMK389 10 mg/kg i.v. | Placebo i.v. |
|---|---|---|
| Started | 31 | 31 |
| Completed | 31 | 31 |
| Not completed | 0 | 0 |
To assess the effect of CMK389 compared to placebo after 16 weeks of treatment on spirometry (Forced Vital Capacity). Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Percent predicted FVC is the percentage of the age, height and gender adjusted predicted value.
| Percent predicted | CMK389 10 mg/kg i.v. | Placebo i.v. |
|---|---|---|
| Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment | -0.48 ± 1.17 | 1.02 ± 1.13 |
The Clinical Status Evaluation (CSE) served as a safety evaluation and served to establish the patient's clinical status (Clinical Status Determination \[CSD\]). CSE was performed prior to the titration of steroids, and the CSD guided selection of the next dose of steroids. Participants with CSD of "improved" or "stable" decreased steroid dose by 1 step on the dosing scale. Participants with CSD of "deteriorating" were ineligible to continue the study (if found during the run-in epoch or at study Day 1); or they increased steroid dose by 1 step (if found during the treatment epoch).
| Participants | CMK389 10 mg/kg i.v. | Placebo i.v. |
|---|---|---|
| Number of Participants Who Had an Increase in Steroid Usage From Baseline to 16 Weeks of Treatment | 5 | 4 |
Composite index of pulmonary physiology (CIPP) and exercise capacity: a participant who deteriorated from baseline to each visit was defined as a patient with: relative reduction if FVC ≥ 10%, or relative reduction if FEV1 ≥ 10%, or relative reduction of DLCO ≥ 15%, or relative reduction of 6MWD ≥ 50 m.
| Participants | CMK389 10 mg/kg i.v. | Placebo i.v. |
|---|---|---|
| Number of Participants Who Deteriorate From Baseline to 16 Weeks of Treatment | 9 | 10 |
\[18F\]-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) maximum standardized uptake value and mean standardized uptake value (SUVmax and SUVmean) imaging was used to assess potential anti-inflammatory effects by CMK389 on the sarcoidosis process. All participants underwent whole-body head to mid-thigh \[18F\]FDG-PET/CT imaging state-of-the-art, 3D PET/CT scanners with a reconstructed resolution of ≤5 mm.
| percent change from Baseline | CMK389 10 mg/kg i.v. | Placebo i.v. |
|---|---|---|
| Lung Parenchyma SUVmax | -29.23 ± 31.128 | 26.78 ± 24.461 |
| Lymph Nodes SUVmax | -23.40 ± 9.083 | -16.48 ± 9.759 |
| Extrathoracic SUVmax | -12.89 ± 14.361 | -19.07 ± 6.908 |
| Lung Parenchyma SUVmean | -34.06 ± 28.626 | 20.74 ± 22.443 |
| Lymph Nodes SUVmean | -30.83 ± 8.157 | -22.75 ± 9.101 |
| Extrathoracic SUVmean | -11.23 ± 13.020 | -23.99 ± 6.440 |
Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis.
| ng/mL | CMK389 10 mg/kg i.v. |
|---|---|
| Day 1 | 453000 (236000 to 1230000) |
| Day 29 | 533000 (58100 to 2460000) |
| Day 57 | 571000 (77600 to 3070000) |
| Day 85 | 541000 (78300 to 893000) |
Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Ctrough is the observed plasma concentration that is just prior to the beginning of a dosing interval.
| ng/mL | CMK389 10 mg/kg i.v. |
|---|---|
| Day 1 | 0.00 (0.00 to 619000) |
| Day 29 | 83500 (43300 to 176000) |
| Day 57 | 105000 (41700 to 182000) |
| Day 85 | 125000 (27900 to 444000) |
FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The least-squares means for change from baseline in FEV1 to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in pre-dose FEV1 is considered a favourable outcome.
| liters (L) | CMK389 10 mg/kg i.v. | Placebo i.v. |
|---|---|---|
| Change in FEV1 From Baseline to 16 Weeks of Treatment | -0.03 ± 0.033 | 0.00 ± 0.032 |
DLCO is a measurement to assess the lungs' ability to transfer gas from inspired air to the bloodstream. The least squares means for change from baseline in DLCO to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in DLCO is considered a favourable outcome.
| mL/min/mmHg | CMK389 10 mg/kg i.v. | Placebo i.v. |
|---|---|---|
| Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks of Treatment | -0.58 ± 0.493 | -0.40 ± 0.448 |
The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters. The least squares means for change from baseline in 6MWD to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in 6MWD is considered a favourable outcome.
| meters | CMK389 10 mg/kg i.v. | Placebo i.v. |
|---|---|---|
| Change in 6-minute Walk Distance (6MWD) From Baseline to 16 Weeks of Treatment | 11.21 ± 9.470 | 10.50 ± 9.223 |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 197 days... Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CMK389 10 mg/kg i.v | 0/31 (0%) | 2/31 (6.5%) | 21/31 (67.7%) |
| Placebo i.v | 0/31 (0%) | 0/31 (0%) | 19/31 (61.3%) |
| Total | 0/62 (0%) | 2/62 (3.2%) | 40/62 (64.5%) |
| Event | CMK389 10 mg/kg i.v | Placebo i.v | Total |
|---|---|---|---|
| Head injuryInjury, poisoning and procedural complications | 1/31 | 0/31 | 1/62 |
| Squamous cell carcinoma of skinNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/31 | 0/31 | 1/62 |
| Event | CMK389 10 mg/kg i.v | Placebo i.v | Total |
|---|---|---|---|
| FatigueGeneral disorders | 4/31 | 4/31 | 8/62 |
| COVID-19Infections and infestations | 3/31 | 4/31 | 7/62 |
| Upper respiratory tract infectionInfections and infestations | 4/31 | 2/31 | 6/62 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/31 | 4/31 | 8/62 |
| HeadacheNervous system disorders | 2/31 | 4/31 | 6/62 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/31 | 4/31 | 6/62 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/31 | 3/31 | 7/62 |
| NauseaGastrointestinal disorders | 3/31 | 1/31 | 4/62 |
| Chest painGeneral disorders | 3/31 | 1/31 | 4/62 |
| Urinary tract infectionInfections and infestations | 1/31 | 3/31 | 4/62 |
| Age, Continuous(years) | CMK389 10 mg/kg i.v. | Placebo i.v. | Total |
|---|---|---|---|
| Mean | 51.5 ± 8.69 | 50.7 ± 9.36 | 51.1 ± 8.96 |
| Sex: Female, Male(Participants) | CMK389 10 mg/kg i.v. | Placebo i.v. | Total |
|---|---|---|---|
| Female | 7 | 13 | 20 |
| Male | 24 | 18 | 42 |
| Race/Ethnicity, Customized(Participants) | CMK389 10 mg/kg i.v. | Placebo i.v. | Total |
|---|---|---|---|
| Black Or African American | 3 | 2 | 5 |
| Unknown | 0 | 1 | 1 |
| White | 28 | 28 | 56 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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