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

• Biological: PD 0360324
  
  100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;
  Other Name: Investigational Study Drug
• Other: Normal Saline for injection
  
  normal saline Q2W via intravenous infusion for 12 weeks

• Experimental: PD 0360324
  
  Intervention: Biological: PD 0360324
• Placebo Comparator: Placebo
  
  Intervention: Other: Normal Saline for injection

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