A Phase 1 Randomized Placebo-Controlled Blinded Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus Cutaneous Lupus Erythematosus Sjogrens Syndrome Systemic Sclerosis Polymyositis and Dermatomyositis

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Updated on 19 February 2024

Summary

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. 32 subjects will be enrolled in 3 cohorts. Cohort 1 has been completed. 24 subjects are needed for Cohorts 2 and 3. Safety and tolerability will be reviewed before starting the next cohort. 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.

Details
Condition lupus, derm, autoimmune
Age 99years or below
Clinical Study Identifier03817424
Last Modified on19 February 2024

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