A Phase 1 interventional study of Edecesertib and Placebo in Cutaneous Lupus Erythematosus, sponsored by Gilead Sciences. Terminated at 5 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Gilead Sciences · Phase 1, Interventional, and Treatment
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).
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.
Drug: Edecesertib · Drug: Standard of Care
Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.
Drug: Placebo · Drug: Standard of Care
Tablets administered orally
Also known as: GS-5718
Placebo to match edecesertib tablets administered orally
Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)
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.
Time frame: 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.
Time frame: First dose date up to 4 weeks plus 28 days
Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Time frame: Predose and up to 6 hours postdose at Week 4
Pharmacokinetic (PK) Parameter: Cmax of Edecesertib
Cmax is defined as the maximum observed concentration of drug.
Time frame: Predose and up to 6 hours postdose at Week 4
Participants were enrolled at sites in the United States.
| Milestone | Edecesertib | Placebo |
|---|---|---|
| Started | 2 | 1 |
| Completed | 1 | 1 |
| Not completed | 1 | 0 |
| Withdrew: Study terminated by sponsor | 1 | 0 |
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 measurements were reported for this outcome.
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 measurements were reported for this outcome.
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
No measurements were reported for this outcome.
Cmax is defined as the maximum observed concentration of drug.
No measurements were reported for this outcome.
Collected over Adverse Events: First dose date up to 4 weeks plus 28 days All-Cause Mortality: First dose date up to approximately 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Edecesertib | — | — | — |
| Placebo | — | — | — |
Safety population included all participants who received at least one dose of study drug.
| Age, Continuous(years) | Edecesertib | Placebo | Total |
|---|---|---|---|
| Mean | NA ± NA | NA ± NA | NA ± NA |
| Sex: Female, Male(Participants) | Edecesertib | Placebo | Total |
|---|---|---|---|
| Female | NA | NA | NA |
| Male | NA | NA | NA |
| Race/Ethnicity, Customized(Participants) | Edecesertib | Placebo | Total |
|---|---|---|---|
| Count of participants | NA | NA | NA |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Gilead Sciences