Clinical Trial: Safety and Efficacy of Filgotinib and GS-9876 in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cu

Brief Summary: The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).

Detailed Summary:
Sponsor: Gilead Sciences

Current Primary Outcome: Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score from Baseline to Week 12 [ Time Frame: Baseline; Week 12 ]

CLASI activity score measures disease activity, with higher scores indicating more severe disease.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of Participants at Week 12 with Decrease of ≥ 5 Points in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 12 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease.
  • Proportion of Participants at Week 12 with No Worsening in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 12 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.
  • Proportion of Participants at Week 24 with Decrease of ≥ 5 Points in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 24 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease.
  • Proportion of Participants at Week 24 with No Worsening in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 24 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.


Original Secondary Outcome: Same as current

Information By: Gilead Sciences

Dates:
Date Received: April 25, 2017
Date Started: May 2017
Date Completion: June 2019
Last Updated: April 25, 2017
Last Verified: April 2017