Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-02 @ 11:42 PM
Study NCT ID:
NCT05048056
Status:
TERMINATED
Last Update Posted:
2025-02-26
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
Sponsor:
Akesobio Australia Pty Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Clinical study and development strategy adjustment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: