Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Interventions
- Drug: Edecesertib Placebo
- Registration Number
- NCT05629208
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 33
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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.
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Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas.
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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.
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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.
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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).
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Individuals willing to comply with all study visits and assessments.
Key
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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.
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Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis).
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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).
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Meet protocol-specified infection or lab criteria.
- Any active infection that is clinically significant (per investigator judgment).
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Any history of clinically significant liver disease.
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Significant cardiovascular disease.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Edecesertib Edecesertib Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks. Edecesertib Placebo Edecesertib Placebo Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 Baseline, Week 12 The CLASI is a standardized, validated measure of cutaneous lupus disease activity and damage, widely used in clinical trials. CLASI consists of CLASI - activity (A) and - damage (D) measurements. CLASI-A scores range from 0 to 70, with higher scores indicating more severe disease activity.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) First dose date up to 12 weeks plus 30 days Percentage of Participants Experiencing Laboratory Abnormalities First dose date up to 12 weeks plus 30 days Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12 Week 12 The CLA-IGA is a measure of cutaneous lupus erythematosus (CLE) activity and will be recorded on a scale of 0 to 4, with 0 indicating "clear" and 4 indicating "severe".
Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs) First dose date up to 12 weeks plus 30 days Plasma Concentration of Edecesertib Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day)
Trial Locations
- Locations (31)
ARENSIA Exploratory Medicine, LLC
🇺🇸Phoenix, Arizona, United States
Center for Dermatology Clinical Research Inc.
🇺🇸Fremont, California, United States
UCSD Perlman Medical Offices
🇺🇸La Jolla, California, United States
Inland Rheumatology Clinical Trials Inc.
🇺🇸Upland, 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
Columbia University Medical Center- Herbert Irving Pavilion
🇺🇸New York, New York, United States
OnSite Clinical Solutions, LLC
🇺🇸Charlotte, North Carolina, United States
Paramount Medical Research & Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Gulf Bank Medical Center
🇺🇸Houston, Texas, United States
Clinical Investigations of Texas
🇺🇸Plano, Texas, United States
Epic Medical Research - Red Oak
🇺🇸Red Oak, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Všeobecná fakultní nemocnice v Praze, Dermatovenerologická klinika
🇨🇿Praha 2, Czechia
Kožní ambulance Fialová, s.r.o.
🇨🇿Praha, Czechia
Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Allergologie und Venerologie Allergie Centrum
🇩🇪Berlin, Germany
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
🇩🇪Dresden, Germany
Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie
🇩🇪Freiburg, Germany
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10
🇩🇪Leipzig, Germany
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital General de Granollers
🇪🇸Granollers, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Spain