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First received: June 05, 2023

Clinical Trial: POC Study to Evaluate BSI-045B Monotherapy and BSI-045B add-on Therapy With Dupilumab in Atopic Dermatitis

Study Status: Completed

Recruit Status: RECRUITING

Condition: Atopic Dermatitis

Study Type: INTERVENTIONAL


Official Title: A Phase 2a, Multicenter, Proof-of-Concept Clinical Trial to Evaluate Efficacy and Safety of BSI-045B mAb Injection as Monotherapy or Add-on Therapy With Dupilumab in Patients With Moderate to Severe A

Brief Summary: 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…

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