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

Exclusion Criteria

• •Diagnosis of significant pulmonary hypertension (WHO group 5) requiring pharmacological treatment
• •Active cardiac sarcoidosis requiring treatment. Inactive cardiac sarcoidosis or stable cardiac sarcoidosis not requiring treatment are permissible.
• •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 use of any inhaled substance, including but not limited to tobacco, marijuana products and use of electronic cigarette or vaping device, and excluding inhalers or nebulizers prescribed for pulmonary sarcoidosis
• •Any conditions or significant medical problems which in the opinion of the investigator and in consultation with the sponsor, 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 not due to Cardiac Sarcoidosis and indicating significant risk of safety for patients participating in the study
• •A diagnosis of Lofgren's syndrome
• •A history of pancreatitis