Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
NCT ID: NCT05629208
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2023-04-17
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Edecesertib
Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.
Edecesertib
Tablets administered orally
Edecesertib Placebo
Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.
Edecesertib Placebo
Tablets administered orally
Interventions
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Edecesertib
Tablets administered orally
Edecesertib Placebo
Tablets administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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ARENSIA Exploratory Medicine, LLC
Phoenix, Arizona, United States
Center for Dermatology Clinical Research Inc.
Fremont, California, United States
University of Colorado, Barbara Davis Center, Center for Clinical Research
Aurora, Colorado, United States
Yale Center for Clinical Investigation (YCCI)
New Haven, Connecticut, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Reliant Medical Research
Miami, Florida, United States
HMD Research LLC
Orlando, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, United States
Gulf Bank Medical Center
Houston, Texas, United States
Clinical Investigations of Texas
Plano, Texas, United States
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
Dresden, , Germany
Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie
Freiburg im Breisgau, , Germany
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10
Leipzig, , Germany
Hospital General de Granollers
Granollers, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-497-6486
Identifier Type: -
Identifier Source: org_study_id
2022-501523-24
Identifier Type: OTHER
Identifier Source: secondary_id
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