Evaluate the Safety, Tolerability of BAT6026

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 1, 2026 → Dec 31, 2026
See other at-risk trials from Bio-Thera Solutions

Record History

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  1. Notable Primary completion pushed from Jun 1, 2026 to Dec 31, 2026
    • Study completion pushed from Jun 30, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 23 words
  2. Notable Primary completion date: Feb 1, 2025 to Jun 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Oct 15, 2025 to Jun 30, 2026
    • Site details revised
    v4
  3. Notable Enrollment target: 126 to 33v3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06094179
Lead Sponsor Bio-Thera Solutions
Conditions
(from sponsor)
Dermatitis, Atopic
Related terms Dermatitis, Atopic
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov