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

Pulmonary Sarcoidosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01732211
• Other study ID #: A6261009
• Status: Terminated
• Phase: Phase 2
• Start date: March 15, 2013
• Est. completion date: September 23, 2013

Study information

• Verified date: December 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 23, 2013
• Est. primary completion date: September 23, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Biological:
• PD 0360324
100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;

Other:
• Normal Saline for injection
normal saline Q2W via intravenous infusion for 12 weeks

Locations

Country	Name	City	State
United States	Iinterstitial Lung Disease & Sarcoidosis Clinic	Cincinnati	Ohio
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	Mount Sinai School Of Medicine/Mount Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 16
Secondary	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.	Baseline, Week 16
Secondary	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.	Baseline, Weeks 2, 4, 8, 12, 14, and 20
Secondary	Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at 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.	Baseline, Weeks 2, 4, 8, 12, 14, and 20
Secondary	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.	Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Secondary	Change From Baseline in % Predicted FEV1 at 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.	Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Secondary	Change From Baseline in Ratio of FEV1/FVC 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. 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.	Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
Secondary	Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks	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.	Baseline, Weeks 0, 2, 4, 8, 12, 14, 16

External Links

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