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

Enrolling By Invitation
99 years or below
All
Phase 1
4 participants needed
1 Location

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. 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: lupus, derm, autoimmune
  • Age: 99 years or below
  • Gender: All
Updated on 19 Feb 2024. Study ID: 832701
If you need help finding a study or have any questions, please contact us at psom-ocr@pobox.upenn.edu

 

Interested in the study?

Message For Enrolling By Invitation Trial

study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact a study center.