NCT01732211TerminatedPhase 2
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 1
- Locations
- 5
- Primary Endpoint
- Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Normal Saline for injection (Other)
PD 0360324
Experimental
Intervention: PD 0360324 (Biological)
Outcomes
Primary Outcomes
Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16
Time Frame: 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 Outcomes
- Change From Baseline in Chest X-ray Global Assessment Score (5-point )(Baseline, Week 16)
- 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)
- 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)
- 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)
- 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)
- Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks(Baseline, Weeks 0, 2, 4, 8, 12, 14, 16)
- 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)
Investigators
Study Sites (5)
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