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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.
 
ClinicalTrials.gov Identifier: NCT01732211
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 22, 2012
Results First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

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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
Actual Study Start Date : March 15, 2013
Actual Primary Completion Date : September 23, 2013
Actual Study Completion Date : September 23, 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;

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




Primary Outcome Measures :
  1. Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16 [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Change From Baseline in Chest X-ray Global Assessment Score (5-point ) [ Time Frame: Baseline, Week 16 ]
    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.

  2. Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20 [ Time Frame: Baseline, 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.

  3. 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 ]
    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.

  4. Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20 [ Time Frame: Baseline, 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.

  5. Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20 [ Time Frame: Baseline, 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.

  6. Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20 [ Time Frame: Baseline, 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.

  7. Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks [ Time Frame: Baseline, Weeks 0, 2, 4, 8, 12, 14, 16 ]
    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.



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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01732211


Locations
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United States, New York
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
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01732211    
Other Study ID Numbers: A6261009
First Posted: November 22, 2012    Key Record Dates
Results First Posted: January 6, 2020
Last Update Posted: January 6, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
Phase 2
Randomized
Double Blind
Placebo Controlled
Parallel
20 Week Safety
Tolerability
and Efficacy Study
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases