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

NCT05629208 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: GS-US-497-64862022-501523-24
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 17

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.

Conditions

Cutaneous Lupus Erythematosus (CLE)

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at 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.

  Baseline, Week 12

Secondary Outcomes (5)

• Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12

  Week 12

• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  First dose date up to 12 weeks plus 30 days

• Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)

  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

• Plasma Concentration of Edecesertib

  Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day)

Study Arms (2)

Edecesertib

EXPERIMENTAL

Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.

Drug: Edecesertib

Edecesertib Placebo

PLACEBO COMPARATOR

Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.

Drug: Edecesertib Placebo

Interventions

Edecesertib DRUG

Tablets administered orally

Also known as: GS-5718

Edecesertib

Edecesertib Placebo DRUG

Tablets administered orally

Edecesertib Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (17)

ARENSIA Exploratory Medicine, LLC

Phoenix, Arizona, 85015, United States

Location

Center for Dermatology Clinical Research Inc.

Fremont, California, 94538, United States

Location

University of Colorado, Barbara Davis Center, Center for Clinical Research

Aurora, Colorado, 80045, United States

Location

Yale Center for Clinical Investigation (YCCI)

New Haven, Connecticut, 06510, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Reliant Medical Research

Miami, Florida, 33165, United States

Location

HMD Research LLC

Orlando, Florida, 32819, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

Gulf Bank Medical Center

Houston, Texas, 77037, United States

Location

Clinical Investigations of Texas

Plano, Texas, 75075, United States

Location

Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie

Dresden, 01307, Germany

Location

Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie

Freiburg im Breisgau, 79104, Germany

Location

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

Leipzig, 04103, Germany

Location

Hospital General de Granollers

Granollers, 08402, Spain

Location

Hospital Universitario de Navarra

Pamplona, 31008, Spain

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: April 17, 2023
• Primary Completion: December 17, 2025
• Study Completion: January 14, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); US (12); ES (2)