Clinical trial NCT01732211: A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Sarcoidosis
Keywords: Phase 2
Randomized
Double Blind
Placebo Controlled
Parallel
20 Week Safety
Tolerability
and Efficacy Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-11-22
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in Chest X-ray Global Assessment Score (5-point )
timeFrame: Baseline, Week 16
measure: Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, 14, and 20
measure: Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, 14, and 20
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
measure: Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
measure: Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
measure: Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks
timeFrame: Baseline, Weeks 0, 2, 4, 8, 12, 14, 16
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School Of Medicine/Mount Sinai Medical Center
state: New York
city: Cincinnati
country: United States
facility: Medical Arts Building
state: Ohio
city: Cincinnati
country: United States
facility: The Barrett Cancer Center at UC Health
state: Ohio
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Iinterstitial Lung Disease & Sarcoidosis Clinic
state: Ohio
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: