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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Tablets administered orally
Tablets administered orally
ARENSIA Exploratory Medicine, LLC
Phoenix, Arizona, United States
Center for Dermatology Clinical Research Inc.
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.
Time frame: Baseline, Week 12
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".
Time frame: Week 12
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 12 weeks plus 30 days
Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)
Time frame: First dose date up to 12 weeks plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame: First dose date up to 12 weeks plus 30 days
Plasma Concentration of Edecesertib
Time frame: Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day)
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Fremont, California, United States
University of Colorado, Barbara Davis Center, Center for Clinical Research
Aurora, Colorado, United States
Yale Center for Clinical Investigation (YCCI)
New Haven, Connecticut, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Reliant Medical Research
Miami, Florida, United States
HMD Research LLC
Orlando, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, United States
...and 7 more locations