Study Details

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.

Participation Requirements

Age

18 Years - 75 Years

Sex

All

Healthy Volunteers

Medical Condition

Cutaneous Lupus Erythematosus (CLE)

Gender

N/A

Date

April 2023 - December 2024

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 (29)

Center for Dermatology Clinical Research Inc.

Fremont, California, United States, 94538

UCSD Perlman Medical Offices

La Jolla, California, United States, 92037

Inland Rheumatology Clinical Trials Inc.

Upland, California, United States, 91786

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

Reliant Medical Research

Miami, Florida, United States, 33165

HMD Research LLC

Orlando, Florida, United States, 32819

Emory University School of Medicine

Atlanta, Georgia, United States, 30303

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

Columbia University Medical Center- Herbert Irving Pavilion

New York, New York, United States, 10032

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, United States, 28204

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States, 44130

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

Philadelphia, Pennsylvania, United States, 19104

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Metroplex Clinical Research Center

Dallas, Texas, United States, 75231

Gulf Bank Medical Center

Houston, Texas, United States, 77037

Epic Medical Research - Red Oak

Red Oak, Texas, United States, 75154

Sun Research Institute

San Antonio, Texas, United States, 78215

Všeobecná fakultní nemocnice v Praze, Dermatovenerologická klinika

Praha 2, Czechia, 128 08

Kožní ambulance Fialová, s.r.o.

Praha, Czechia, 100 34

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

Berlin, Germany

Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie

Dresden, Germany, 01307

Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie

Freiburg, Germany, 79104

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

Leipzig, Germany, 04103

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 8023

Hospital General de Granollers

Granollers, Spain, 08402

Hospital Universitario Infanta Leonor

Madrid, Spain, 28031

Hospital Universitario de Navarra

Pamplona, Spain, 31008

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

OVERVIEW