A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)
Primary Objective
To evaluate the efficacy of GS-5718 versus placebo-to-match (PTM) in reducing skin disease activity for participants with CLE with or without systemic lupus erythematosus. To evaluate the efficacy of GS-5718 versus PTM in reducing skin disease activity for participants with CLE with or without SLE. To evaluate the safety and tolerability of GS-5178 in participants with CLE with or without SLE.
Description
This is a Phase 2s multicenter randomized study to evaluate the efficacy, safety and tolerability of GS-5178 in participants with Cutaneous Lupus Erythematosus. Participants who meet eligible criteria will be randomized in a 2:1 ratio to one of the two treatment groups: GS-5178 2 15mg tablets once daily or Placebo to match 2 15mg tablets once daily. The duration of intervention if upto 12 weeks.
Details
Locations
Outpatient CTRC
Principal Investigator
Christopher Striebich
Study ID
Protocol Number: 23-1287
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