A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Pulmonary Sarcoidosis
In brief
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.
Key facts
- Study ID
- NCT01732211
- Run by
- Pfizer
- People needed
- 1
- Starts
- 2013-03-15
- Expected to finish
- 2013-09-23
- Last updated by the study team
- 2020-01-06
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Mount Sinai School Of Medicine/Mount Sinai Medical Center — New York, New York, United States
- Medical Arts Building — Cincinnati, Ohio, United States
- The Barrett Cancer Center at UC Health — Cincinnati, Ohio, United States
- University Hospital — Cincinnati, Ohio, United States
- Iinterstitial Lung Disease & Sarcoidosis Clinic — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.