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Lupus skin drug trial halted early – what we know

NCT ID NCT05629208

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental oral drug called edecesertib (GS-5718) in 20 people with cutaneous lupus erythematosus, a condition where lupus affects the skin. The goal was to see if the drug could reduce skin disease activity and improve symptoms. However, the trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Edecesertib (also called GS-5718), an oral tablet
What this could lead to
If successful, this could point toward a new treatment option for people with cutaneous lupus erythematosus, a skin condition caused by lupus.
What could go wrong
This was a very small, early-phase study that was terminated early, so we don't know if the drug works or is safe. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

20 people

The number who actually took part.

Started

Apr 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous lupus erythematosus (CLE)

Contacts and locations

Locations

  • ARENSIA Exploratory Medicine, LLC

    Phoenix, Arizona, 85015, United States

  • Center for Dermatology Clinical Research Inc.

    Fremont, California, 94538, United States

  • Clinical Investigations of Texas

    Plano, Texas, 75075, United States

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765, United States

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

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

    Philadelphia, Pennsylvania, 19104, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30303, United States

  • Gulf Bank Medical Center

    Houston, Texas, 77037, United States

  • HMD Research LLC

    Orlando, Florida, 32819, United States

  • Hospital General de Granollers

    Granollers, 08402, Spain

  • Hospital Universitario de Navarra

    Pamplona, 31008, Spain

  • Reliant Medical Research

    Miami, Florida, 33165, United States

  • Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie

    Freiburg im Breisgau, 79104, Germany

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

    Aurora, Colorado, 80045, United States

  • Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie

    Dresden, 01307, Germany

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

    Leipzig, 04103, Germany

  • Yale Center for Clinical Investigation (YCCI)

    New Haven, Connecticut, 06510, United States

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