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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501523-24 | Other Identifier | European Medicines Agency |
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Sponsor Decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edecesertib | Experimental | Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks. |
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| Edecesertib Placebo | Placebo Comparator | Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edecesertib | Drug | Tablets administered orally |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Week 12 |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) |
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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.
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 history of clinically significant liver disease.
Significant cardiovascular disease.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARENSIA Exploratory Medicine, LLC | Phoenix | Arizona | 85015 | United States | ||
| Center for Dermatology Clinical Research Inc. |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Edecesertib Placebo | Drug | Tablets administered orally |
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| 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) |
| Fremont |
| California |
| 94538 |
| United States |
| University of Colorado, Barbara Davis Center, Center for Clinical Research | Aurora | Colorado | 80045 | United States |
| Yale Center for Clinical Investigation (YCCI) | New Haven | Connecticut | 06510 | United States |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | United States |
| Reliant Medical Research | Miami | Florida | 33165 | United States |
| HMD Research LLC | Orlando | Florida | 32819 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30303 | 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 |
| Gulf Bank Medical Center | Houston | Texas | 77037 | United States |
| Clinical Investigations of Texas | Plano | Texas | 75075 | United States |
| Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie | Dresden | 01307 | Germany |
| Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie | Freiburg im Breisgau | 79104 | Germany |
| Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10 | Leipzig | 04103 | Germany |
| Hospital General de Granollers | Granollers | 08402 | Spain |
| Hospital Universitario de Navarra | Pamplona | 31008 | Spain |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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