A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis

A PHASE 2 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, 20-WEEK SAFETY, TOLERABILITY, AND EFFICACY STUDY OF PD 0360324 IN ADULT SUBJECTS WITH CHRONIC PULMONARY SARCOIDOSIS

The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies.

The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.

Inclusion Criteria:

• Diagnosis of biopsy-proved chronic pulmonary sarcoidosis either Stage 2 or Stage 3 for at least 1 year;
• Forced Vital Capacity (FVC) lung assessment of >40% and < or = to 80% predicted normal values at screening;
• age 21-75 years of age;
• treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10 and 30 mg of prednisone) for at least 3 months prior to Screening; (other anti-inflammatory drugs may be permitted as defined by the study protocol)

Exclusion Criteria:

• History of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring maintenance treatment, chronic obstructive pulmonary disease (COPD));
• Pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, TB, HIV);
• treatment with other biologic anti-inflammatory/immuno-modulatory drugs;
• active smokers;
• class 3 or 4 congestive heart failure;
• cancer, or history of cancer within past 5 years;
• history of ischemic heart disease, heart attack, stroke, any heart muscle disease;
• liver disease;
• history of alcohol or drug abuse