A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
- Conditions
- Pulmonary Sarcoidosis
- Interventions
- Other: Normal Saline for injectionBiological: PD 0360324
- Registration Number
- NCT01732211
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Normal Saline for injection - PD 0360324 PD 0360324 -
- Primary Outcome Measures
Name Time Method Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16 Baseline, Week 16 The percent predicted FVC was calculated by observed FVC/predicted FVC \* 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Chest X-ray Global Assessment Score (5-point ) Baseline, Week 16 Digital copies of Chest x-rays performed during the study were graded according to a 5 point Likert scale: 1 = markedly worsened; 2 = worsened; 3 = unchanged; 4 = improved; and 5 = markedly improved. Baseline will be defined as the last available x-ray prior to first dose.
Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20 Baseline, Weeks 2, 4, 8, 12, 14, and 20 FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20 Baseline, Weeks 2, 4, 8, 12, 14, and 20 The percent predicted FVC was calculated by observed FVC/predicted FVC \* 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20 Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20 Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 The percent predicted FEV1 was calculated by observed FEV1/predicted FEV1 \* 100. The predicted FEV1 values was calculated according to age, height, race and gender. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks Baseline, Weeks 0, 2, 4, 8, 12, 14, 16 FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Through FVC was obtained from spirometry, performed before study treatment administration.
Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20 Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Trial Locations
- Locations (5)
Medical Arts Building
🇺🇸Cincinnati, Ohio, United States
The Barrett Cancer Center at UC Health
🇺🇸Cincinnati, Ohio, United States
Mount Sinai School Of Medicine/Mount Sinai Medical Center
🇺🇸New York, New York, United States
University Hospital
🇺🇸Cincinnati, Ohio, United States
Iinterstitial Lung Disease & Sarcoidosis Clinic
🇺🇸Cincinnati, Ohio, United States