Cutaneous Lupus Erythematosus
Conditions
Brief summary
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).
Interventions
DRUGEdecesertib
Tablets administered orally
DRUGPlacebo
Placebo to match edecesertib tablets administered orally
DRUGStandard of Care
Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Either fulfill the European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) or have biopsy-proven cutaneous lupus erythematosus (CLE). * Must have active acute cutaneous lupus erythematosus (ACLE)/ subacute cutaneous lupus erythematosus (SCLE); individuals with mixed skin presentations of lupus skin disease (including DLE) are allowed to enter. * CLE Disease Area and Severity Index (CLASI) activity score of ≥ 6 during screening and Day 1, excluding the alopecia component. * Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and willingness to undergo skin biopsy at 2 time points. * Protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents for the treatment of CLE/SLE (eg, antimalarials, methotrexate (MTX), or other conventional synthetic disease-modifying antirheumatic drug (csDMARDs)) must maintain stable dose(s) for ≥ 60 days prior to randomization through Week 4 of the study. Key
Exclusion criteria
* Dermatologic disease other than cutaneous manifestations of SLE or CLE that may interfere with assessment of lupus-specific skin lesions. * Ongoing or active clinically significant bacterial, fungal or viral infection. * History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus. * Uncontrolled health conditions including highly active SLE (e.g. lupus nephritis, neuropsychiatric SLE, vasculitis etc.). * History of malignancy. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Treatment-emergent Adverse Events | First dose date up to 4 weeks plus 28 days | 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. |
| Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities | First dose date up to 4 weeks plus 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib | Predose and up to 6 hours postdose at Week 4 | AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
| Pharmacokinetic (PK) Parameter: Cmax of Edecesertib | Predose and up to 6 hours postdose at Week 4 | Cmax is defined as the maximum observed concentration of drug. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at sites in the United States.
Pre-assignment details
7 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Terminated by Sponsor | 1 | 0 |
Baseline characteristics
| Characteristic | Edecesertib | Placebo | Total |
|---|---|---|---|
| Age, Continuous | NA years | NA years | NA years |
| Race/Ethnicity, Customized | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: First dose date up to 4 weeks plus 28 days
Population: 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.
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.
Time frame: First dose date up to 4 weeks plus 28 days
Population: 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.
Secondary
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
Population: Data not reported for participant confidentiality reasons.
Secondary
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
Population: Data not reported for participant confidentiality reasons.