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

Phase 2TerminatedNCT01732211

Pfizer1 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Pulmonary Sarcoidosis

Interventions

PD 0360324BIOLOGICAL

100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;

Normal Saline for injectionOTHER

normal saline Q2W via intravenous infusion for 12 weeks

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at 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.

Time frame: Baseline, Week 16

Secondary Outcomes

Change From Baseline in Chest X-ray Global Assessment Score (5-point )

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.

Time frame: Baseline, Week 16

Change From Baseline in FVC (Absolute ) Compared to Placebo at 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.

Time frame: 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

Time frame: 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

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.

Data from ClinicalTrials.gov

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