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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01732211
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 22, 2012
Last Update Posted : November 26, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pulmonary Sarcoidosis Biological: PD 0360324 Other: Normal Saline for injection Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in % predicted Forced Vital Capacity (FVC) compared to placebo at Week 16. [ Time Frame: Baseline to 16 weeks ]
    Primary efficacy endpoint

Secondary Outcome Measures :
  1. Change in chest X ray global assessment score (5 point Likert Scale) [ Time Frame: Baseline to 20 weeks ]
    Secondary Efficacy Endpoint

  2. 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) ]
    Secondary Efficacy Endpoint

  3. Estimated treatment effect over placebo in FVC averaged over 16 weeks. [ Time Frame: Baseline to Week 16 ]
    Secondary Efficacy Endpoint

  4. 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 ]
    Secondary Efficacy Endpoint

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01732211

United States, New York
Drug Shipment Address- Mount Sinai School of Medicine
New York, New York, United States, 10029
Mount Sinai School Of Medicine/Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Ohio
Medical Arts Building
Cincinnati, Ohio, United States, 45219
The Barrett Cancer Center at UC Health
Cincinnati, Ohio, United States, 45219
University Hospital
Cincinnati, Ohio, United States, 45219
Iinterstitial Lung Disease & Sarcoidosis Clinic
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01732211     History of Changes
Other Study ID Numbers: A6261009
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: October 2015

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

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