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 ]

Primary efficacy endpoint


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