A PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF RSLV-132 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
- assess the impact of 13 IV infusions of RSLV-132 on cutaneous lupus disease activity using the CLASI activity score. -assess improvement in disease activity using SLEDAI-2K, BILAG-2004 and PGA; - evaluate the immunogenicity of RSLV-132 in subjects with SLE; - assess improvement in tender or swollen joint count; - assess improvement in patient reported outcomes using the FACIT-Fatigue scale; - assess the ability of subjects to reduce oral steroids at Day 169; ? evaluate the safety and tolerability of 22 weeks of RSLV-132 exposure; - assess the proportion of subjects achieving a 50% improvement in CLASI activity score - assess the following exploratory endpoints -- evaluate the impact of RSLV-132 treatment on gene expression profile; -- evaluate the impact of RSLV-132 treatment on autoantibody and complement profiles; -- evaluate the impact of RSLV-132 on serum protein levels; -- assess the impact of RSLV-132 on the CLASI damage score
This Study is
No Longer Enrolling
Adult
II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Treatment
National
Barbara Davis Center
UCD Barbara Davis Center
University of Colorado Hospital
Protocol Number: 16-0603
More information available at ClinicalTrials.gov: NCT02660944
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