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

NCT05932654 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-10-15

Study results available
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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.

Conditions

Interventions

DRUG

BSI-045B

Patients will be treated with BSI-045B.

Sponsors & Collaborators

  • Biosion, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2024-09-18
Completion
2024-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05932654 on ClinicalTrials.gov