Cutaneous Lupus Erythematosus (CLE)Phase 2COSMICNCT05629208
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
A Phase 2 study testing Edecesertib in people with Cutaneous Lupus Erythematosus (CLE), run by Gilead Sciences at 17 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cutaneous Lupus Erythematosus (CLE)
- What is being tested?
- Edecesertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 17 Apr 2023to 14 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States12 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
University of Colorado, Barbara Davis Center, Center for Clinical Research
Aurora, Colorado, 80045
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Center for Dermatology Clinical Research Inc.
Fremont, California, 94538
Gulf Bank Medical Center
Houston, Texas, 77037
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Reliant Medical Research
Miami, Florida, 33165
Yale Center for Clinical Investigation (YCCI)
New Haven, Connecticut, 06510
HMD Research LLC
Orlando, Florida, 32819
Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, 19104
ARENSIA Exploratory Medicine, LLC
Phoenix, Arizona, 85015
Clinical Investigations of Texas
Plano, Texas, 75075
Germany3 sites
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
Dresden, 01307
Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie
Freiburg im Breisgau, 79104
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10
Leipzig, 04103
Spain2 sites
Hospital General de Granollers
Granollers, 08402
Hospital Universitario de Navarra
Pamplona, 31008
About this study
Official title: 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.
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Being tested
- Edecesertib, Edecesertib Placebo
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdecesertibDrug
Also called GS-5718
Tablets administered orally
Edecesertib PlaceboDrug
Tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Edecesertib | Experimental | Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks. Receives: Drug: Edecesertib |
| Edecesertib Placebo | Placebo comparator | Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks. Receives: Drug: Edecesertib Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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".
Measured: Week 12
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: First dose date up to 12 weeks plus 30 days
Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)
Measured: First dose date up to 12 weeks plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Measured: First dose date up to 12 weeks plus 30 days
Plasma Concentration of Edecesertib
Measured: Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start17 Apr 2023
- Primary completion17 Dec 2025
- Study completion14 Jan 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus Erythematosus (CLE)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629208
- Sponsor's protocol ID
- GS-US-497-6486
- Other IDs
- 2022-501523-24
- Acronym
- COSMIC
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05629208
- Acronym / sponsor ID
- COSMIC / GS-US-497-6486
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edecesertib | Experimental | Drug: EdecesertibParticipants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks. |
| Edecesertib Placebo | Placebo comparator | Drug: Edecesertib PlaceboParticipants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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 history of clinically significant liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdecesertibAlso: GS-5718Tablets administered orally | Drug | Edecesertib |
| Edecesertib PlaceboTablets administered orally | Drug | Edecesertib Placebo |
Primary outcome
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.
5 secondary outcomes
Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12
Time frame: Week 12
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: 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
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame: 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)
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Edecesertib in people with Cutaneous Lupus Erythematosus (CLE), run by Gilead Sciences at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.