This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
TriWest Research Associates
El Cajon, California, United States
University of California San Diego
La Jolla, California, United States
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward \[LOCF\] post censoring values). The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Time frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Percentage of participants achieving a 50% improvement in CLASI activity score at Day 85 and Day 169 (LOCF post censoring due to use of exclusionary medications)
Time frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
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Wallace Rheumatic Study Center
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University of Colorado
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Center for Rheumatology, Immunology and Arthritis
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Northwell Health/ Division of Rheumatology
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...and 6 more locations