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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Tablets administered orally
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)
Wallace Rheumatic Studies Center, LLC
Beverly Hills, California, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Dawes Fretzin Clincial Research Group, LLC
Indianapolis, Indiana, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
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
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Metroplex Clinical Research Center
Dallas, Texas, United States