Evaluation of VIB7734 in Autoimmune Diseases
Brief description of study
A Phase 1, randomized, blinded,placebo-controlled study to evaluate the safety and tolerability of multiple-ascending SC doses of VIB7734 in selected autoimmune diseases (SLE, CLE, Sjogrens syndrome, systemic sclerosis, polymyositis, dermatomyositis), and efficacy on skin lupus activity.
Three doses VIB7734 will be given SC in ascending doses per cohort every 4 weeks.
Key eligibility criteria: Subjects must be 18 to 75 years of age and have SLE or CLE with an active skin lesion and baseline CLASI activity score of greater than or equal to 8. Subjects in Cohorts 2 and 3 must also be willing to undergo a skin punch biopsy at two time points. Screening, Trx, Follow-up periods. Duration 169 days or up to 365 days according to labs.
Main interventions: PEs, vital signs, ECGs, clinical assessments, blood/urine/pregnancy/TB tests, photos, bxs, genetic test-optional.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
lupus,dermatoloy,autoimmune
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Age: Between 18 Years - 99 Years
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Gender: All
Updated on
17 Sep 2021.
Study ID: 832701