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

NCT01732211 | Terminated Phase 2 Results DMC

• 1 other identifier: A6261009
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 5

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.

Conditions

Pulmonary Sarcoidosis

Keywords

Phase 2; Randomized; Double Blind; Placebo Controlled; Parallel; 20 Week Safety; Tolerability; and Efficacy Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

PD 0360324

EXPERIMENTAL

Biological: PD 0360324

Placebo

PLACEBO COMPARATOR

Other: Normal Saline for injection

Interventions

PD 0360324 BIOLOGICAL

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

PD 0360324

Normal Saline for injection OTHER

normal saline Q2W via intravenous infusion for 12 weeks

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Mount Sinai School Of Medicine/Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Medical Arts Building

Cincinnati, Ohio, 45219, United States

Location

The Barrett Cancer Center at UC Health

Cincinnati, Ohio, 45219, United States

Location

University Hospital

Cincinnati, Ohio, 45219, United States

Location

Iinterstitial Lung Disease & Sarcoidosis Clinic

Cincinnati, Ohio, 45267, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

Saline Solution; Injections

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

Due to early termination of the study and the small enrollment number, analysis of primary and secondary pharmacodynamic endpoints could not be performed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: March 15, 2013
• Primary Completion: September 23, 2013
• Study Completion: September 23, 2013
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

US (5)