The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms. This study is seeking for participants who: * are adults of 18 years of age or older. * are confirmed to have CLE or SLE with involvement of the skin. * have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8. About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins). At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60. The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
Placebo (intravenous infusion)
PF-06823859 (intravenous infusion)
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States
Dermatology Research Associates
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
...and 9 more locations
Change from baseline in type 1 IFN GS score in lesional skin at Week 12
A 13-gene IFN gene signature score was used to measure IFN activity at both baseline and week 12, the gene signature score is assessed per sample by averaging the log2CPM(Counts Per Million reads) values of these 13 genes through RNAseq profiling. The gene signature score is positively linked to the gene expression activity of those 13 genes that are related to IFN.
Time frame: Week 12
Percent change from baseline in CLASI-A score at Week 12
The Cutaneous Lupus Erythematosus Disease Activity and Damage Score
Time frame: Week 12
Percent change from baseline in CLASI-A (over time in addition to Week 12)
Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score
Time frame: Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
Change from baseline in CLASI-A score (over time)
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score
Time frame: Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time)
Achieving ≥50%, 4 or 7 points reduction in CLASI-A
Time frame: Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
Change from baseline in Physician global assessment (PhGA) (over time)
The PhGA is a visual analog scale (VAS) tool to measure worsening in the participant general health status. Physician will place a mark on the scale between 0 (none), 1 (mild), 2(moderate) and 3 (severe).
Time frame: Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time
Time frame: Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 56, and 60
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