NCT05932654

POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis

A Phase 2a, Multicenter, Proof-of-Concept Clinical Trial to Evaluate Efficacy and Safety of BSI-045B mAb Injection in Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Biosion, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. The study will enroll patients with moderate to severe AD to receive the 300 mg treatment. BSI-045B wil be firstly given weekly during Week 1 to Week 4, and then every 2 weeks (Q2W) to Week 24.

Detailed 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 in patients with moderate to severe AD. The study will be unblinded. Following a loading dose of BSI-045B (300 mg) SC QW for 4 weeks, patients will move to maintanence 300 mg SC Q2W through Week 24. There will be a 12-week Follow-up Period after treatment. A Safety Steering Committee (SSC) will monitor the study to identify questions concerning safety. The primary efficacy endpoint is the proportion of patients with ≥EASI75 at Week 26 (2 weeks after last dose at Week 24), compared with baseline (Day1). Additional efficacy outcomes also include other scores on EASI, Investigator's Global Assessment (IGA), Facial IGA, and Peak Pruritus Numerical Rating Scale (PP-NRS). 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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	BSI-045B	Patients will be treated with BSI-045B.

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2023-07-06
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study