Wright State Physicians | Pharmacology Translational Unit
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The study is a multicenter clinical trial and is designed as a proof-of-concept study to evaluate the efficacy, safety, tolerability, PK, immunogenicity, and PD of BSI-045B following SC injections, as monotherapy or as add-on therapy with dupilumab.
The study will enroll patients with moderate to severe AD in 4 cohorts. There will be 2 Monotherapy Cohorts, assigned to different doses of BSI-045B: a 300 mg Cohort and a 480 mg Cohort. There will be 2 Add-on Therapy Cohorts, assigned to different doses of BSI-045B: a 300 mg Cohort and a 480 mg Cohort. Patients in the Monotherapy Cohorts will be treated with BSI 045B. Patients in the Add-on Therapy Cohorts will be treated with BSI-045B, concomitantly with steady-state dupilumab treatment.
Patients in each of these 4 cohorts will initially be treated with a loading dose of BSI-045B given every week (QW) for 3 weeks. Thereafter, BSI-045B will be administered every 2 weeks (Q2W) and patients will receive their assigned dose of BSI-045B (300 mg or 480 mg) Q2W through Week 24.
Full description
This study is a Phase 2a, proof-of-concept clinical study designed to evaluate the efficacy, safety, tolerability, PK, immunogenicity, and PD of BSI-045B injection after 12 and 24 weeks of treatment with BSI 045B, without (Monotherapy Cohorts) or with dupilumab (Add-on Therapy Cohorts) in patients with moderate to severe AD. The study will be unblinded.
Following a loading dose of BSI-045B (300 mg or 480 mg) SC QW for 3 weeks, patients will move to a dose (300 mg or 480 mg) SC Q2W through Week 24. The total Treatment Period for both the Monotherapy Cohorts and the Add-on Therapy Cohorts will be 24 weeks, followed by a 12-week Follow-up Period.
The SC will monitor the study to identify questions concerning safety and eligibility.
The primary efficacy endpoint is the proportion of patients with EASI75 at Week 12, compared with baseline. Efficacy assessments will be conducted at Screening, within the first hour prior to dosing on Day 1, at all subsequent visits, and at the time of early withdrawal from the study.
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Main inclusion Criteria:
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Primary purpose
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Interventional model
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80 participants in 4 patient groups
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Central trial contact
Hugh M Davis, PhD; Chu Zhang, PhD
Data sourced from clinicaltrials.gov
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