A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01732211
First received: November 19, 2012
Last updated: May 12, 2013
Last verified: May 2013
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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 ]
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 ]
- 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 ]
- Estimated treatment effect over placebo in FVC averaged over 16 weeks. [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
- 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 ]
| 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
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, New York | |
| Pfizer Investigational Site | Recruiting |
| New York, New York, United States, 10029-6574 | |
| United States, Ohio | |
| Pfizer Investigational Site | Recruiting |
| 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: | May 12, 2013 |
| 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 May 22, 2013