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Testing edecesertib for treating skin lupus

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)

Phase 2 Interventional Gilead Sciences · NCT05629208

This study is testing a new drug called edecesertib to see if it can help people with skin lupus feel better and manage their symptoms.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment33 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorGilead Sciences Industry-sponsored
Drugs / interventionsmethotrexate
Locations31 sites (Phoenix, Arizona and 30 other locations)
Trial IDNCT05629208 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the effectiveness of edecesertib, a drug previously known as GS-5718, in treating participants with Cutaneous Lupus Erythematosus (CLE). The study will assess how the body responds to the drug, monitor any side effects, and gather information on the disease's progression. Participants will undergo skin punch biopsies to provide representative samples for analysis. The study will include individuals with active CLE and those meeting specific criteria for systemic lupus erythematosus.

Who should consider this trial

Good fit: Ideal candidates include individuals with active Cutaneous Lupus Erythematosus who have not responded adequately to previous treatments.

Not a fit: Patients with stable or inactive forms of Cutaneous Lupus Erythematosus may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Cutaneous Lupus Erythematosus for affected patients.

How similar studies have performed: Other studies have explored treatments for lupus, but the specific use of edecesertib in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

Where this trial is running

Phoenix, Arizona and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cutaneous Lupus Erythematosus
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.