NCT06176040

A Study of TAVO101 in Atopic Dermatitis Patients

A Pilot Phase 2A Study to Examine the Preliminary Efficacy, Safety and PK of TAVO101 in Patients with Moderate to Severe Atopic Dermatitis (AD)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tavotek Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 pilot study to examine the preliminary efficacy, safety and PK of TAVO101 in adult patients with moderate and severe AD.

Detailed description

This is a Phase 2 pilot study to examine the preliminary efficacy, safety and PK of TAVO101 in adult patients with moderate and severe AD. The total treatment and observation period is 24 weeks in duration of which the last dose of drug will be given by Week 16, leaving the last 8 weeks as an extra period for safety monitoring. Approximately 20 patients will be randomized in a 1:1:1:1 ratio to receive intravenous treatment of TAVO101 in 4 different dosing schemes. TAVO101 in 210-420 mg flat dose administered every 4 to 12 weeks will be tested to examine the preliminary effect of different dose and dosing interval in managing atopic dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	TAVO101	TAVO101 IV Infusion.

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-03-15
• Completion: 2025-06-15
• First posted: 2023-12-19
• Last updated: 2024-11-18

Locations

2 sites across 2 countries: Australia, New Zealand