A Phase 2 interventional study of Placebo and AK120 in Atopic Dermatitis, sponsored by Akesobio Australia Pty Ltd. Terminated at 24 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Akesobio Australia Pty Ltd (part of Akeso) · Phase 2, Interventional, and Treatment
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.
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:
Secondary Objectives:
1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's enrollment of 79 is close to the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Akesobio Australia Pty Ltd is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.
Drug: AK120
AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.
Drug: AK120
Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation
Drug: Placebo · Drug: AK120
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
Time frame: At week 16
Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)
Time frame: At week 16
Change in SCORing Atopic Dermatitis (SCORAD)
Time frame: Baseline to Week 38
Change in Pruritus-Numerical Rating Scale (P-NRS)
Time frame: Baseline to Week 38
Change in Body Surface Area (BSA) of AD involvement
Time frame: Baseline to Week 38
Change in Patient Oriented Eczema Measure (POEM)
Time frame: Baseline to Week 38
Individual subject AK120 concentrations in serum at different time points after AK120 administration
Time frame: Baseline to Week 38
Change in pharmacodynamics studies TARC/CCL17 and IgE
Time frame: Baseline to week 24
Anti-drug antibodies(ADAs)
Time frame: Baseline to Week 38
Adverse events(AEs)/serious adverse events(SAEs)
Time frame: Baseline to Week 38
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in May 2023, 19 months.
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This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AK120