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

Last updated: March 25, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

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: 33
Treatment Group(s): 2
Primary Treatment: Edecesertib Placebo
Phase: 2
Study Start date:
April 17, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Kožní ambulance Fialová, s.r.o.

    Praha, 160 00
    Czechia

    Site Not Available

  • Všeobecná fakultní nemocnice v Praze, Dermatovenerologická klinika

    Praha 2, 128 08
    Czechia

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Allergologie und Venerologie Allergie Centrum

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie

    Freiburg, 79104
    Germany

    Active - Recruiting

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

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8023
    Spain

    Site Not Available

  • Hospital General de Granollers

    Granollers, 08402
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital Universitario de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • ARENSIA Exploratory Medicine, LLC

    Phoenix, Arizona 85015
    United States

    Active - Recruiting

  • Center for Dermatology Clinical Research Inc.

    Fremont, California 94538
    United States

    Active - Recruiting

  • UCSD Perlman Medical Offices

    La Jolla, California 92037
    United States

    Site Not Available

  • Inland Rheumatology Clinical Trials Inc.

    Upland, California 91786
    United States

    Site Not Available

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

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Yale Center for Clinical Investigation (YCCI)

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Reliant Medical Research

    Miami, Florida 33165
    United States

    Active - Recruiting

  • HMD Research LLC

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Emory University School of Medicine

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Columbia University Medical Center- Herbert Irving Pavilion

    New York, New York 10032
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

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

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Metroplex Clinical Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Gulf Bank Medical Center

    Houston, Texas 77037
    United States

    Active - Recruiting

  • Clinical Investigations of Texas

    Plano, Texas 75075
    United States

    Active - Recruiting

  • Epic Medical Research - Red Oak

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

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