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)
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 f
Why this Research Matters
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 tre
Who can Participate
Male and nonpregnant female between the ages of 18 years to 75 years. Must have active CLE at the time of screening and day 1. Participants should be willing to undergo punch biopsy at 2 time points while in the study. Participants must have documented prior intolerance or inadequate response to at least one- a) Topical corticosteroid or topical calcineurin inhibitors b) Oral corticosteroid c) Any other nonbiologic standard-of-care therapy, including, but not limited
Study ID
Protocol Number: 23-1287
Meet the Team
Christopher Striebich, MD, PhD
Principal Investigator