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

February 13, 2026 updated by: Gilead Sciences

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
      • Freiburg im Breisgau, Germany, 79104
        • Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10
  • Spain
      • Granollers, Spain, 08402
        • Hospital General de Granollers
      • Pamplona, Spain, 31008
        • Hospital Universitario de Navarra
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • ARENSIA Exploratory Medicine, LLC
    • California
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Barbara Davis Center, Center for Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Center for Clinical Investigation (YCCI)
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Miami, Florida, United States, 33165
        • Reliant Medical Research
      • Orlando, Florida, United States, 32819
        • HMD Research LLC
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
    • Texas
      • Houston, Texas, United States, 77037
        • Gulf Bank Medical Center
      • Plano, Texas, United States, 75075
        • Clinical Investigations of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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) 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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edecesertib
Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.
Drug: Edecesertib
Tablets administered orally
Other Names:
  • GS-5718
Placebo Comparator: Edecesertib Placebo
Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.
Drug: Edecesertib Placebo
Tablets administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
Time Frame: 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.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12
Time Frame: 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".
Week 12
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose date up to 12 weeks plus 30 days
First dose date up to 12 weeks plus 30 days
Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)
Time Frame: First dose date up to 12 weeks plus 30 days
First dose date up to 12 weeks plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Time Frame: First dose date up to 12 weeks plus 30 days
First dose date up to 12 weeks plus 30 days
Plasma Concentration of Edecesertib
Time Frame: Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day)
Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Actual)

December 17, 2025

Study Completion (Actual)

January 14, 2026

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-497-6486
  • 2022-501523-24 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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