Chronic pulmonary sarcoidosis MedDRA version: 20.0 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: CMK389
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: CMK389
Current Sponsor code: CMK389
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must have a body mass index (BMI) at screening within the range of 18 - 34 kg/m2. BMI = Body weight (kg) / [Height (m)]2 - Biopsy proven pulmonary sarcoidosis diagnosed > 1 year prior to screening - Scadding stage II, III or IV as determined by the most recent chest x-ray obtained within 12 months prior to screening or at screening (confirmed by the Investigator) - HRCT =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Diagnosis of pulmonary hypertension (WHO group 5) - A known diagnosis of cardiac sarcoidosis - A known diagnosis of neurosarcoidosis - Forced vital capacity (FVC) <50% of predicted at screening (central read) - Modified British Medical Research Council (mMRC) dyspnea scale = 3 at screening - Concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab, etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and abatacept within 12 weeks of screening - Prior treatment with rituximab, canakinumab, anakinra, and tocilizumab - Current smokers, defined as inhaled use of tobacco products - Any conditions or significant medical problems which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for immunomodulatory therapy - Contraindication to FDG-PET scan investigations such as severe claustrophobia or uncontrolled diabetes - History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study - Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this proof of concept study is to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.;Secondary Objective: Not applicable;Primary end point(s): Change in forced vital capacity, % of predicted, between CMK389 and placebo.;Timepoint(s) of evaluation of this end point: Baseline to Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Composite index of pulmonary physiology and exercise capacity: 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: Change in imaging maximum standardized uptake value and mean standardized uptake value. - Pulmonary physiology: Change in forced expiratory volume in one second and diffusion capacity for carbon monoxide. - Steroid use (mg days): Difference in steroid usage for each arm of the study. - Exercise capacity: Change in 6-minute walk distance. - Pharmacokinetics of CMK389 maximum concentration (Cmax): The observed maximum plasma concentration (Cmax) following drug administration [mass / volume]. - Pharmacokinetics of CMK389 trough concentration (Ctrough): The lowest concentration of drug (Ctrough) reached before the next dose is administered. - Pharmacokinetics of CMK389 area under the curve (AUC): 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]. ;Timepoint(s) of evaluation of this end point: Baseline to Week 16 Pharmacokinetic endpoints: Day 1 though Week 28 | — |
Countries
Czech Republic, Denmark, Germany, Poland, United Kingdom, United States
Contacts
Public ContactMedica Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed