for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
completion around



The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE. Information on what is happening in the body relating to CLE, how the body processes, is affected by and responds to the study drug, and any study drug side effects will also be collected in this study.

Official Title

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)


Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Edecesertib


You can join if…

Open to people ages 18-75

  • Either fulfill European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) and/or have biopsy confirmed Cutaneous Lupus Erythematosus (CLE) at any time.
  • Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas.
  • Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening.
  • Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points.
  • Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments.
    • Topical corticosteroids or topical calcineurin inhibitors.
    • Oral corticosteroids.
    • Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).
  • Individuals willing to comply with all study visits and assessments.

You CAN'T join if...

  • Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localized acute CLE involving only 1 distinct body area at screening and Day 1.
  • Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis).
  • Presence of active skin conditions other than cutaneous lupus that may interfere with assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-induced lupus).
  • Meet protocol-specified infection or lab criteria.
    • Any active infection that is clinically significant (per investigator judgment).
  • Any history of clinically significant liver disease.
  • Significant cardiovascular disease.

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.


  • UCSD Perlman Medical Offices accepting new patients
    La Jolla California 92037 United States
  • Inland Rheumatology Clinical Trials Inc. accepting new patients
    Upland California 91786 United States


accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website
Phase 2 Lupus Research Study
Study Type
Expecting 33 study participants
Last Updated