Clinical Trial

Evaluate the Safety, Tolerability of BAT6026

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated February 10, 2026 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a Phase IB/IIA clinical study of BAT6026 in patients with AD. The subjects were adults with moderate to severe atopic dermatitis (AD) whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate. The first phase was the phase IB study, which was double-blind controlled by placebo in the group and consisted of 3 dose groups. After completing the dose escalation study, the phase IIA study was entered. The Phase IIA study was a randomized, double-blind, controlled, multicentering clinical trial with different dose groups and placebo groups. The primary endpoint was to explore the efficacy and safety of BAT6026 in patients with eczema area and severity index (EASI) of at least 75% lower than the baseline at week 16 after 4 treatment cycles. To provide the optimal dose for the phase III regimen.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-10-19; most recent amendment 2026-02-09.
Status change: Recruiting → Active, Not Recruiting 2026-02-09
Status change: Not Yet Recruiting → Recruiting 2024-01-17
Trial Details
NCT Number NCT06094179
Lead Sponsor Bio-Thera Solutions
Conditions Dermatitis, Atopic
Enrollment 33 participants
Start Date 2023-11-09
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-10