NCT05048056

Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis

A Phase 2, Multi-center, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of AK120 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Akesobio Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study, conducted in subjects with moderate-to-severe atopic dermatitis.

Detailed description

This phase 2 study is designed to explore the efficacy and safety, as well as pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of dose-ranging AK120 compared to placebo, which will generate information regarding the selection of dosing regimens with AK120 monotherapy treatment in adult subjects with moderate-to-severe AD. Primary Objectives: • To evaluate the efficacy of AK120 in the treatment of adult subjects with moderate-to-severe Atopic Dermatitis (AD). Secondary Objectives: * To evaluate the safety of AK120 in the treatment of adult subjects with moderate-to-severe AD. * To evaluate the Pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AK120 in adult subjects with moderate-to-severe AD.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
DRUG	AK120	AK120 Regimen 1- subcutaneous injection every 2 weeks.
DRUG	AK120	AK120 Regimen 2- subcutaneous injection every 2 weeks

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2021-09-17
• Last updated: 2025-02-26

Locations

24 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study