OVERVIEW
A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE) (COSMIC)
PROTOCOL 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.
View moreParticipation requirements
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Cutaneous Lupus Erythematosus (CLE)
Gender
N/A
Date
April 2023 - December 2025
Study Type
Interventional
Study Phase
Phase 2
Product
Edecesertib, Edecesertib Placebo
Eligibility information
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) 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
- 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.
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (17)
ARENSIA Exploratory Medicine, LLC
Phoenix, Arizona, United States, 85015
Center for Dermatology Clinical Research Inc.
Fremont, California, United States, 94538
University of Colorado, Barbara Davis Center, Center for Clinical Research
Aurora, Colorado, United States, 80045
Yale Center for Clinical Investigation (YCCI)
New Haven, Connecticut, United States, 06510
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, United States, 19104
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
Dresden, Germany, 01307
Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie
Freiburg im Breisgau, Germany, 79104
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10
Leipzig, Germany, 04103
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