At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
BSI-045Bdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating BSI-045B for Atopic Dermatitis. Completed, enrolled 22 participants across 17 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202420252026
First PostedJul 2023
Enrollment StartJul 2023
Primary CompletionSep 2024
TodayJul 2026
First PostedJul 6, 2023
Enrollment StartJul 31, 2023
Primary CompletionSep 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.0 years ago
Interventions
BSI-045Bdrug
Patients will be treated with BSI-045B.