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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05048056




Registration number
NCT05048056
Ethics application status
Date submitted
9/09/2021
Date registered
17/09/2021
Date last updated
7/07/2022

Titles & IDs
Public title
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
AK120-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - AK120
Treatment: Drugs - AK120

Experimental: AK120 Regimen 1 - AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.

Experimental: AK120 Regimen 2 - AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.

Experimental: Placebo to AK120 - Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation


Treatment: Drugs: Placebo
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1

Treatment: Drugs: AK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.

Treatment: Drugs: AK120
AK120 Regimen 2- subcutaneous injection every 2 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
Timepoint [1] 0 0
At week 16
Secondary outcome [1] 0 0
Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)
Timepoint [1] 0 0
At week 16
Secondary outcome [2] 0 0
Change in SCORing Atopic Dermatitis (SCORAD)
Timepoint [2] 0 0
Baseline to Week 38
Secondary outcome [3] 0 0
Change in Pruritus-Numerical Rating Scale (P-NRS)
Timepoint [3] 0 0
Baseline to Week 38
Secondary outcome [4] 0 0
Change in Body Surface Area (BSA) of AD involvement
Timepoint [4] 0 0
Baseline to Week 38
Secondary outcome [5] 0 0
Change in Patient Oriented Eczema Measure (POEM)
Timepoint [5] 0 0
Baseline to Week 38
Secondary outcome [6] 0 0
Individual subject AK120 concentrations in serum at different time points after AK120 administration
Timepoint [6] 0 0
Baseline to Week 38
Secondary outcome [7] 0 0
Change in pharmacodynamics studies TARC/CCL17 and IgE
Timepoint [7] 0 0
Baseline to week 24
Secondary outcome [8] 0 0
Anti-drug antibodies(ADAs)
Timepoint [8] 0 0
Baseline to Week 38
Secondary outcome [9] 0 0
Adverse events(AEs)/serious adverse events(SAEs)
Timepoint [9] 0 0
Baseline to Week 38

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2024
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
AkesoBio Investigative Site 3003 - Sydney
Recruitment hospital [2] 0 0
AkesoBio Investigative Site 3002 - Woolloongabba
Recruitment hospital [3] 0 0
AkesoBio Investigative Site 3001 - Camberwell
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3145 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Mississippi
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
South Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Christchurch
Country [11] 0 0
New Zealand
State/province [11] 0 0
Hamilton
Country [12] 0 0
New Zealand
State/province [12] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Akesobio Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05048056
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yu Zhang
Address 0 0
Country 0 0
Phone 0 0
+86 (0760) 8987 3999
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05048056