Phase
Condition
Lupus
Cutaneous Lupus Erythematosus
Systemic Lupus Erythematosus
Treatment
Edecesertib Placebo
Edecesertib
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Kožní ambulance Fialová, s.r.o.
Praha, 100 34
CzechiaActive - Recruiting
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
Dresden 2935022, 01307
GermanySite Not Available
Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie
Freiburg im Breisgau 2925177, 79104
GermanySite Not Available
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10
Leipzig 2879139, 04103
GermanySite Not Available
Hospital General de Granollers
Granollers 3121145, 08402
SpainSite Not Available
Hospital Universitario de Navarra
Pamplona 3114472, 31008
SpainSite Not Available
ARENSIA Exploratory Medicine, LLC
Phoenix 5308655, Arizona 5551752 85015
United StatesSite Not Available
Center for Dermatology Clinical Research Inc.
Fremont 5350734, California 5332921 94538
United StatesSite Not Available
University of Colorado, Barbara Davis Center, Center for Clinical Research
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Yale Center for Clinical Investigation (YCCI)
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
Clinical Research of West Florida, Inc.
Clearwater, Florida 33765
United StatesActive - Recruiting
Clinical Research of West Florida, Inc.
Clearwater 4151316, Florida 4155751 33765
United StatesSite Not Available
Reliant Medical Research
Miami 4164138, Florida 4155751 33165
United StatesSite Not Available
HMD Research LLC
Orlando 4167147, Florida 4155751 32819
United StatesSite Not Available
Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30303
United StatesSite Not Available
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis 4259418, Indiana 4921868 46250
United StatesSite Not Available
Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Metroplex Clinical Research Center
Dallas, Texas 75231
United StatesActive - Recruiting
Gulf Bank Medical Center
Houston 4699066, Texas 4736286 77037
United StatesSite Not Available
Clinical Investigations of Texas
Plano 4719457, Texas 4736286 75075
United StatesSite Not Available

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