Clinical Trial: A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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 Sa
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.
Detailed Summary: 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.
Sponsor: Pfizer
Current Primary Outcome: Change from baseline in % predicted Forced Vital Capacity (FVC) compared to placebo at Week 16. [ Time Frame: Baseline to 16 weeks ]
Original Primary Outcome: 'Change from baseline in % predicted Forced Vital Capacity (FVC) compared to placebo at Week 16". [ Time Frame: Baseline to 16 weeks ]
Current Secondary Outcome:
- Change in chest X ray global assessment score (5 point Likert Scale) [ Time Frame: Baseline to 20 weeks ]Secondary Efficacy Endpoint
- 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
- Estimated treatment effect over placebo in FVC averaged over 16 weeks. [ Time Frame: Baseline to Week 16 ]Secondary Efficacy Endpoint
- 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
Original Secondary Outcome:
- Change in chest X ray global assessment score (5 point Likert Scale) [ Time Frame: Baseline to 20 weeks ]
- 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) ]
- Estimated treatment effect over placebo in FVC averaged over 16 weeks. [ Time Frame: Baseline to Week 16 ]
- 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 ]
Information By: Pfizer
Dates:
Date Received: November 19, 2012
Date Started: March 2013
Date Completion:
Last Updated: October 30, 2015
Last Verified: October 2015