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

Last updated on May 9, 2018

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 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

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A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Pulmonary Sarcoidosis
  • 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
  • Experimental: PD 0360324
    Intervention: Biological: PD 0360324
  • Placebo Comparator: Placebo
    Intervention: Other: Normal Saline for injection
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01732211
A6261009
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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