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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048056
• Other study ID #: AK120-203
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: July 2022
• Source: Akeso
• Contact: Yu Zhang
• Phone: +86 (0760) 8987 3999
• Email: global.trials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: January 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Male or female, over the age of 18

2. Chronic atopic dermatitis (AD) diagnosed at least 1 year.

3. Subject with EASI score =16, IGA = 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe), = 10% body surface area (BSA) of AD involvement.

4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.

Key Exclusion Criteria:

1. Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents).

2. History of exposure to active TB, and/or history or current evidence of TB infection.

3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.

4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.

5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit

6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Placebo
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
• AK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.
• AK120
AK120 Regimen 2- subcutaneous injection every 2 weeks

Locations

Country	Name	City	State
Australia	AkesoBio Investigative Site 3001	Camberwell	Victoria
Australia	AkesoBio Investigative Site 3003	Sydney	New South Wales
Australia	AkesoBio Investigative Site 3002	Woolloongabba	Queensland
New Zealand	AkesoBio Investigative Site 4001	Auckland
New Zealand	AkesoBio Investigative Site 4003	Auckland
New Zealand	AkesoBio Investigative Site 4005	Christchurch
New Zealand	AkesoBio Investigative Site 4004	Hamilton
New Zealand	AkesoBio Investigative Site 4004	Wellington
United States	AkesoBio Investigative Site 2010	Canoga Park	California
United States	AkesoBio Investigative Site 2009	Hialeah	Florida
United States	AkesoBio Investigative Site 2001	Hollywood	Florida
United States	AkesoBio Investigative Site 2004	Houston	Texas
United States	AkesoBio Investigative Site 2018	Houston	Texas
United States	AkesoBio Investigative Site 2015	Las Vegas	Nevada
United States	AkesoBio Investigative Site 2003	Little Rock	Arkansas
United States	AkesoBio Investigative Site 2011	Miami	Florida
United States	AkesoBio Investigative Site 2005	Rapid City	South Dakota
United States	AkesoBio Investigative Site 2022	Ridgeland	Mississippi
United States	AkesoBio Investigative Site 2021	San Diego	California
United States	AkesoBio Investigative Site 2023	San Diego	California
United States	AkesoBio Investigative Site 2017	San Francisco	California
United States	AkesoBio Investigative Site 2020	Sherman Oaks	California
United States	AkesoBio Investigative Site 2013	Spartanburg	South Carolina
United States	AkesoBio Investigative Site 2002	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Akesobio Australia Pty Ltd

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response		At week 16
Secondary	Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)		At week 16
Secondary	Change in SCORing Atopic Dermatitis (SCORAD)		Baseline to Week 38
Secondary	Change in Pruritus-Numerical Rating Scale (P-NRS)		Baseline to Week 38
Secondary	Change in Body Surface Area (BSA) of AD involvement		Baseline to Week 38
Secondary	Change in Patient Oriented Eczema Measure (POEM)		Baseline to Week 38
Secondary	Individual subject AK120 concentrations in serum at different time points after AK120 administration		Baseline to Week 38
Secondary	Change in pharmacodynamics studies TARC/CCL17 and IgE		Baseline to week 24
Secondary	Anti-drug antibodies(ADAs)		Baseline to Week 38
Secondary	Adverse events(AEs)/serious adverse events(SAEs)		Baseline to Week 38