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

Last updated on February 28, 2019

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Study Location
Drug Shipment Address- Mount Sinai School of Medicine
New York, New York, 10029 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Sarcoidosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT01732211
Pfizer
Terminated
A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis

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