Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

Last updated: February 13, 2026
Sponsor: Gilead Sciences
Overall Status: Terminated

Phase

2

Condition

Lupus

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Treatment

Edecesertib Placebo

Edecesertib

Clinical Study ID

NCT05629208
GS-US-497-6486
2022-501523-24-00
2022-501523-24
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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) musthave 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 screeningand on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus DiseaseActivity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening.

  • Presence of at least 1 representative lupus skin lesion amenable to punch biopsy andindividual willingness to undergo skin punch biopsy at 2 time points.

  • Must have documented prior intolerance or inadequate response at any time (perinvestigator 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, mycophenolatemofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).

  • Individuals willing to comply with all study visits and assessments.

Exclusion

Key Exclusion Criteria:

  • Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/orlocalized 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 interferewith assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-inducedlupus).

  • Meet protocol-specified infection or lab criteria.

  • Any active infection that is clinically significant (per investigatorjudgment).

  • Any history of clinically significant liver disease.

  • Significant cardiovascular disease.

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

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Edecesertib Placebo
Phase: 2
Study Start date:
April 17, 2023
Estimated Completion Date:
January 14, 2026

Connect with a study center

  • Kožní ambulance Fialová, s.r.o.

    Praha, 100 34
    Czechia

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie

    Freiburg im Breisgau 2925177, 79104
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10

    Leipzig 2879139, 04103
    Germany

    Site Not Available

  • Hospital General de Granollers

    Granollers 3121145, 08402
    Spain

    Site Not Available

  • Hospital Universitario de Navarra

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • ARENSIA Exploratory Medicine, LLC

    Phoenix 5308655, Arizona 5551752 85015
    United States

    Site Not Available

  • Center for Dermatology Clinical Research Inc.

    Fremont 5350734, California 5332921 94538
    United States

    Site Not Available

  • University of Colorado, Barbara Davis Center, Center for Clinical Research

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Yale Center for Clinical Investigation (YCCI)

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc.

    Clearwater 4151316, Florida 4155751 33765
    United States

    Site Not Available

  • Reliant Medical Research

    Miami 4164138, Florida 4155751 33165
    United States

    Site Not Available

  • HMD Research LLC

    Orlando 4167147, Florida 4155751 32819
    United States

    Site Not Available

  • Emory University School of Medicine

    Atlanta 4180439, Georgia 4197000 30303
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Site Not Available

  • Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Metroplex Clinical Research Center

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Gulf Bank Medical Center

    Houston 4699066, Texas 4736286 77037
    United States

    Site Not Available

  • Clinical Investigations of Texas

    Plano 4719457, Texas 4736286 75075
    United States

    Site Not Available

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