You are here

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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Drug Shipment Address- Mount Sinai School of Medicine
New York, New York, 10029 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Sarcoidosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01732211
Pfizer
Terminated
A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionThe 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Pulmonary Sarcoidosis
Intervention  ICMJE
  • 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
  • Other: Normal Saline for injection
    normal saline Q2W via intravenous infusion for 12 weeks
Study Arms  ICMJE
  • Experimental: PD 0360324
    Intervention: Biological: PD 0360324
  • Placebo Comparator: Placebo
    Intervention: Other: Normal Saline for injection
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 12, 2014)
1
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2012)
120
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion DateSeptember 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01732211
Other Study ID Numbers  ICMJE A6261009
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now