Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change between baseline and week 12 in pulmonary tissue inflammation as measured by [F-18]FDG-PET/CT [ Time Frame: Baseline and Week 12 ]
  To determine the effect of ACZ885 on the change of pulmonary tissue inflammation as measured by [F-18]FDG-PET/CT from baseline after 12 weeks of treatment compared to placebo.
• Change from baseline in other parameters of pulmonary function testing [ Time Frame: Baseline and Week 24 ]
  To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline.
• Change from baseline in High Resolution Computed Tomography (HRCT) scoring [ Time Frame: Baseline and Week 24 ]
  To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis at 24 weeks compared to initial HRCT scan as measured by side-by-side comparison by blinded reviewers and HRCT scoring.
• Change from baseline distance walked as assessed by the 6-minute walk test [ Time Frame: Baseline, Week 12, and Week 24 ]
  To determine the effect of ACZ885 versus placebo on the 6-minute walk test distance of patients with sarcoidosis at 12 and 24 weeks compared to baseline
• Change from baseline of additional [F-18]FDG-PET outcomes [ Time Frame: Baseline and Week 12 ]
  To determine the effect of ACZ885 on additional [F-18]FDG-PET outcomes after 12 weeks of treatment compared to placebo.

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: August 16, 2016
Date Started: October 2016
Date Completion: July 2018
Last Updated: August 29, 2016
Last Verified: August 2016