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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01732211
First received: November 19, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Sarcoidosis
Biological: PD 0360324
Other: Normal Saline for injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in % predicted Forced Vital Capacity (FVC) compared to placebo at Week 16. [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
    Primary efficacy endpoint


Secondary Outcome Measures:
  • Change in chest X ray global assessment score (5 point Likert Scale) [ Time Frame: Baseline to 20 weeks ] [ Designated as safety issue: No ]
    Secondary Efficacy Endpoint

  • Change from baseline in FVC (absolute and % predicted) compared to placebo at other time points post baseline except Week 16. [ Time Frame: Baseline to 20 weeks (except Week 16) ] [ Designated as safety issue: No ]
    Secondary Efficacy Endpoint

  • Estimated treatment effect over placebo in FVC averaged over 16 weeks. [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    Secondary Efficacy Endpoint

  • Change from baseline in other spirometric parameters at all timepoints post baseline: Forced Expiratory Volume in 1 Second (FEV1), % predicted FEV1, ratio of FEV1/FVC. [ Time Frame: all timepoints post baseline ] [ Designated as safety issue: No ]
    Secondary Efficacy Endpoint


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD 0360324 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 Name: Investigational Study Drug
Placebo Comparator: Placebo Other: Normal Saline for injection
normal saline Q2W via intravenous infusion for 12 weeks

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732211

Locations
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80206
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01732211     History of Changes
Other Study ID Numbers: A6261009
Study First Received: November 19, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 2
Randomized
Double Blind
Placebo Controlled
Parallel
20 Week Safety
Tolerability
and Efficacy Study

Additional relevant MeSH terms:
Sarcoidosis
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014