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



Status:Terminated
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 75
Updated:4/21/2016
Start Date:March 2013
End Date:September 2013

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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
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Cincinnati, Ohio 45219
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