Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis

Inclusion Criteria:

• Male and female subjects with active symptomatic pulmonary sarcoidosis, (definitediagnosis of active pulmonary sarcoidosis per ATS guidelines)

• Treatment-naïve or previously treated (no recruitment cap)

• Parenchymal pulmonary involvement on [18F]FDG PET/CT

Exclusion Criteria:

• Requirement for immediate start of standard of care therapy for pulmonarysarcoidosis

• Active cardiac or neuro- sarcoidosis

• History of/active Löfgren syndrome

• Clinically significant lung disease other than sarcoidosis (e.g. tuberculosis,asthma, Chronic Obstructive Pulmonary Disease, interstitial lung disease, lungcancer) or any current inflammatory or immunological systemic disease other thansarcoidosis

• Potentially effective systemic or inhaled pharmacological (includinginvestigational) therapy for sarcoidosis (whether pulmonary or other disease), withthe exception of any of the following:

1. corticosteroids received not later than 3 months prior to enrolment

2. immunosuppressants or anti-Tumor Necrosis Factor (TNF) agents (or otheranti-inflammatory/anti-fibrotic treatment) received not later than 4 monthsprior to enrolment

• Systemic treatment indication being an extrapulmonary location of sarcoidosis (e.g.,neurological)

• Heart conditions: QTcF interval prolongation, cardiac arrhythmia (other thannon-sustained supraventricular arrhythmia), heart failure (New York HeartAssociation class III or IV) and/or known myocardial hypertrophy or Left VentricleEjection Fraction <50% in the cardiac MRI

• Known neurosarcoidosis or small fiber neuropathy or medical conditions causingprimary ataxia

• Lab abnormalities: Abnormal bilirubin, transaminases, alkaline phosphatase (ALP),Creatinine clearance (CrCL) Hypokalemia hypocalcemia (<2.1 mmol/L), markedfasting hyperglycemia at screening

• Uncontrolled diabetes at Screening with plasma glucose exceeding 8.3 mmol/L, orother contraindication to [18F]FDG administration and/or PET procedure (includingbody temperature >37°C and any metabolic disease affecting the energy metabolismof muscles) as described in the PET protocol

• Known positivity for Human Immunodeficiency Virus (HIV 1/2 antibodies), hepatitis Bvirus (HBV), or hepatitis C virus (HCV), or detected at screening

• Severe, uncontrolled systemic disease (e.g., cardiovascular, pulmonary, thyroid,renal or metabolic disease) at Screening, or other condition, which in the opinionof the investigator, would compromise the safety of the subject or the subject'sability to participate in the study

• Current smoker of >5 cigarettes or e-cigarettes per day or user ofnicotine-releasing alternatives (patches, chewing gums etc)

• Prohibited medications: Current treatment with drug with QT prolongation effect,thiazide diuretics, strong CYP3A4 inhibitors and/or inducers, P-glycoprotein and/orBCRP strong inhibitors, drugs that are sensitive substrates of OCT1, MATE1, MATE2K,OAT3 with a narrow therapeutic index, pirfenidone and nintedanib.