Trial Outcomes & Findings for Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis (NCT NCT04064242)

Last Updated: 2025-04-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2025-04-13

Participant Flow

Participants took part in 22 investigative sites in 6 countries.

After obtaining signed informed consent, a screening epoch of 28 days was used to assess subject eligibility.

Participant milestones

Participant milestones
Measure	CMK389 10 mg/kg i.v. CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. Placebo i.v. every 4 weeks for a total of 4 doses
Overall Study STARTED	31	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CMK389 10 mg/kg i.v. n=31 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. n=31 Participants Placebo i.v. every 4 weeks for a total of 4 doses	Total n=62 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 8.69 • n=5 Participants	50.7 years STANDARD_DEVIATION 9.36 • n=7 Participants	51.1 years STANDARD_DEVIATION 8.96 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: The Pharmacodynamic (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Data collected after a change of the steroid dose not based on the clinical status evaluation (CSE) algorithm were excluded from the analysis set if assessed as having a potentially relevant impact on PD data.

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=26 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. n=27 Participants Placebo i.v. every 4 weeks for a total of 4 doses
Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment	-0.48 Percent predicted Standard Deviation 1.17	1.02 Percent predicted Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Data collected after a change of the steroid dose not based on the CSE algorithm were excluded from the analysis set if assessed as having a potentially relevant impact on PD data.

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).

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=29 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. n=31 Participants Placebo i.v. every 4 weeks for a total of 4 doses
Number of Participants Who Had an Increase in Steroid Usage From Baseline to 16 Weeks of Treatment	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

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.

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=29 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. n=31 Participants Placebo i.v. every 4 weeks for a total of 4 doses
Number of Participants Who Deteriorate From Baseline to 16 Weeks of Treatment	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

\[18F\]-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.

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=29 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. n=31 Participants Placebo i.v. every 4 weeks for a total of 4 doses
Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment Lymph Nodes SUVmax	-23.40 percent change from Baseline Standard Error 9.083	-16.48 percent change from Baseline Standard Error 9.759
Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment Extrathoracic SUVmax	-12.89 percent change from Baseline Standard Error 14.361	-19.07 percent change from Baseline Standard Error 6.908
Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment Lung Parenchyma SUVmax	-29.23 percent change from Baseline Standard Error 31.128	26.78 percent change from Baseline Standard Error 24.461
Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment Lung Parenchyma SUVmean	-34.06 percent change from Baseline Standard Error 28.626	20.74 percent change from Baseline Standard Error 22.443
Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment Lymph Nodes SUVmean	-30.83 percent change from Baseline Standard Error 8.157	-22.75 percent change from Baseline Standard Error 9.101
Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment Extrathoracic SUVmean	-11.23 percent change from Baseline Standard Error 13.020	-23.99 percent change from Baseline Standard Error 6.440

SECONDARY outcome

Timeframe: Post 1 hour: Day 1, Day 29, Day 57, Day 85

Population: The Pharmacokinetics (PK) analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received CMK389 and with no protocol deviations with relevant impact on PK data.

Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=31 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. Placebo i.v. every 4 weeks for a total of 4 doses
The Observed Serum Concentration Following CMK389 Administration at End of Infusion Day 1	453000 ng/mL Interval 236000.0 to 1230000.0	—
The Observed Serum Concentration Following CMK389 Administration at End of Infusion Day 29	533000 ng/mL Interval 58100.0 to 2460000.0	—
The Observed Serum Concentration Following CMK389 Administration at End of Infusion Day 57	571000 ng/mL Interval 77600.0 to 3070000.0	—
The Observed Serum Concentration Following CMK389 Administration at End of Infusion Day 85	541000 ng/mL Interval 78300.0 to 893000.0	—

SECONDARY outcome

Timeframe: Pre-dose: Day 1, Day 29, Day 57, Day 85

Population: The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received CMK389 and with no protocol deviations with relevant impact on PK data.

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.

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=31 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. Placebo i.v. every 4 weeks for a total of 4 doses
Pre-dose Trough Concentration (Ctrough) of CMK389 Day 1	0.00 ng/mL Interval 0.0 to 619000.0	—
Pre-dose Trough Concentration (Ctrough) of CMK389 Day 29	83500 ng/mL Interval 43300.0 to 176000.0	—
Pre-dose Trough Concentration (Ctrough) of CMK389 Day 57	105000 ng/mL Interval 41700.0 to 182000.0	—
Pre-dose Trough Concentration (Ctrough) of CMK389 Day 85	125000 ng/mL Interval 27900.0 to 444000.0	—

SECONDARY outcome

Timeframe: Baseline, Week 16

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.

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=26 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. n=27 Participants Placebo i.v. every 4 weeks for a total of 4 doses
Change in FEV1 From Baseline to 16 Weeks of Treatment	-0.03 liters (L) Standard Error 0.033	0.00 liters (L) Standard Error 0.032

SECONDARY outcome

Timeframe: Baseline, Week 16

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.

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=20 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. n=25 Participants Placebo i.v. every 4 weeks for a total of 4 doses
Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks of Treatment	-0.58 mL/min/mmHg Standard Error 0.493	-0.40 mL/min/mmHg Standard Error 0.448

SECONDARY outcome

Timeframe: Baseline, Week 16

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.

Outcome measures

Outcome measures
Measure	CMK389 10 mg/kg i.v. n=26 Participants CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v. n=26 Participants Placebo i.v. every 4 weeks for a total of 4 doses
Change in 6-minute Walk Distance (6MWD) From Baseline to 16 Weeks of Treatment	11.21 meters Standard Error 9.470	10.50 meters Standard Error 9.223

Adverse Events

CMK389 10 mg/kg i.v

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo i.v

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Total

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CMK389 10 mg/kg i.v n=31 participants at risk CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v n=31 participants at risk Placebo i.v. every 4 weeks for a total of 4 doses	Total n=62 participants at risk Total
Injury, poisoning and procedural complications Head injury	3.2% 1/31 • 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..	0.00% 0/31 • 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..	1.6% 1/62 • 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..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	3.2% 1/31 • 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..	0.00% 0/31 • 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..	1.6% 1/62 • 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..

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	CMK389 10 mg/kg i.v n=31 participants at risk CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses	Placebo i.v n=31 participants at risk Placebo i.v. every 4 weeks for a total of 4 doses	Total n=62 participants at risk Total
Gastrointestinal disorders Diarrhoea	3.2% 1/31 • 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..	6.5% 2/31 • 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..	4.8% 3/62 • 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..
Gastrointestinal disorders Nausea	9.7% 3/31 • 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..	3.2% 1/31 • 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..	6.5% 4/62 • 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..
General disorders Chest pain	9.7% 3/31 • 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..	3.2% 1/31 • 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..	6.5% 4/62 • 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..
General disorders Fatigue	12.9% 4/31 • 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..	12.9% 4/31 • 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..	12.9% 8/62 • 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..
Infections and infestations COVID-19	9.7% 3/31 • 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..	12.9% 4/31 • 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..	11.3% 7/62 • 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..
Infections and infestations Nasopharyngitis	6.5% 2/31 • 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..	6.5% 2/31 • 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..	6.5% 4/62 • 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..
Infections and infestations Upper respiratory tract infection	12.9% 4/31 • 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..	6.5% 2/31 • 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..	9.7% 6/62 • 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..
Infections and infestations Urinary tract infection	3.2% 1/31 • 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..	9.7% 3/31 • 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..	6.5% 4/62 • 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..
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/31 • 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..	6.5% 2/31 • 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..	3.2% 2/62 • 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..
Investigations Blood alkaline phosphatase increased	0.00% 0/31 • 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..	6.5% 2/31 • 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..	3.2% 2/62 • 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..
Investigations Blood creatinine increased	6.5% 2/31 • 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..	0.00% 0/31 • 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..	3.2% 2/62 • 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..
Investigations Lipase increased	6.5% 2/31 • 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..	0.00% 0/31 • 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..	3.2% 2/62 • 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..
Musculoskeletal and connective tissue disorders Arthralgia	12.9% 4/31 • 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..	12.9% 4/31 • 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..	12.9% 8/62 • 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..
Musculoskeletal and connective tissue disorders Back pain	9.7% 3/31 • 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..	3.2% 1/31 • 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..	6.5% 4/62 • 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..
Musculoskeletal and connective tissue disorders Myalgia	3.2% 1/31 • 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..	6.5% 2/31 • 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..	4.8% 3/62 • 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..
Nervous system disorders Dizziness	9.7% 3/31 • 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..	3.2% 1/31 • 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..	6.5% 4/62 • 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..
Nervous system disorders Headache	6.5% 2/31 • 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..	12.9% 4/31 • 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..	9.7% 6/62 • 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..
Renal and urinary disorders Haematuria	0.00% 0/31 • 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..	6.5% 2/31 • 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..	3.2% 2/62 • 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..
Respiratory, thoracic and mediastinal disorders Cough	6.5% 2/31 • 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..	12.9% 4/31 • 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..	9.7% 6/62 • 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..
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.9% 4/31 • 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..	9.7% 3/31 • 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..	11.3% 7/62 • 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..
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	6.5% 2/31 • 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..	3.2% 1/31 • 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..	4.8% 3/62 • 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..
Skin and subcutaneous tissue disorders Cutaneous sarcoidosis	6.5% 2/31 • 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..	0.00% 0/31 • 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..	3.2% 2/62 • 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..
Vascular disorders Hypertension	6.5% 2/31 • 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..	3.2% 1/31 • 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..	4.8% 3/62 • 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..