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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000204-38 | EudraCT Number |
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Sponsor decision to terminate study.
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The primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly GS-5718) in participants with cutaneous lupus erythematosus (CLE) with or without systemic lupus erythematosus (SLE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edecesertib | Experimental | Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks. |
|
| Placebo | Experimental | Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edecesertib | Drug | Tablets administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Treatment-emergent Adverse Events | Treatment-emergent Adverse Events (TEAEs) were defined as AEs with onset dates on or after the study treatment start date and no later than 28 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatments. | First dose date up to 4 weeks plus 28 days |
| Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 28 days after last study drug administration. | First dose date up to 4 weeks plus 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib | AUCtau is defined as the area under the concentration versus time curve over the dosing interval. | Predose and up to 6 hours postdose at Week 4 |
| Pharmacokinetic (PK) Parameter: Cmax of Edecesertib |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Wallace Rheumatic Studies Center, LLC | Beverly Hills | California | 90211 | United States | ||
| Clinical Research of West Florida, Inc. |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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7 participants were screened.
Participants were enrolled at sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Edecesertib | Participants received edecesertib at a dose of 115 mg orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy. |
| FG001 | Placebo | Participants received placebo to match edecesertib orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Edecesertib | Participants received edecesertib at a dose of 115 mg orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Treatment-emergent Adverse Events | Treatment-emergent Adverse Events (TEAEs) were defined as AEs with onset dates on or after the study treatment start date and no later than 28 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatments. | No data was reported for adverse events due to low number of participants in both Edicescertib and Placebo arms, in order to protect and maintain participant privacy/confidentiality. | Posted | First dose date up to 4 weeks plus 28 days |
|
Adverse Events: First dose date up to 4 weeks plus 28 days All-Cause Mortality: First dose date up to approximately 10 weeks
No data was reported for adverse events due to low number of participants in both Edicescertib and Placebo arms, in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Edecesertib | Participants received edecesertib at a dose of 115 mg orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2021 | Sep 8, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2023 | Sep 8, 2023 | SAP_001.pdf |
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| 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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Placebo | Drug | Placebo to match edecesertib tablets administered orally |
|
| Standard of Care | Drug | Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone) |
|
Cmax is defined as the maximum observed concentration of drug. |
| Predose and up to 6 hours postdose at Week 4 |
| Clearwater |
| Florida |
| 33765 |
| United States |
| Dawes Fretzin Clincial Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
Participants received placebo to match edecesertib orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Placebo |
Participants received placebo to match edecesertib orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy. |
|
| Primary | Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 28 days after last study drug administration. | No data was reported for adverse events due to low number of participants in both Edicescertib and Placebo arms, in order to protect and maintain participant privacy/confidentiality. | Posted | First dose date up to 4 weeks plus 28 days |
|
|
| Secondary | Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib | AUCtau is defined as the area under the concentration versus time curve over the dosing interval. | Data not reported for participant confidentiality reasons. | Posted | Predose and up to 6 hours postdose at Week 4 |
|
|
| Secondary | Pharmacokinetic (PK) Parameter: Cmax of Edecesertib | Cmax is defined as the maximum observed concentration of drug. | Data not reported for participant confidentiality reasons. | Posted | Predose and up to 6 hours postdose at Week 4 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Participants received placebo to match edecesertib orally in form of tablets once daily for up to 4 weeks. The participants continued their standard of care therapy. | 0 | 0 | 0 | 0 | 0 | 0 |
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: