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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04256174




Registration number
NCT04256174
Ethics application status
Date submitted
3/02/2020
Date registered
5/02/2020

Titles & IDs
Public title
A Study of AK120 (IL-4Ra) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis
Scientific title
A Phase 1, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AK120 in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis
Secondary ID [1] 0 0
AK120-101
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 - AK120 or placebo- Part 1- Cohort 1
Treatment: Drugs - AK120 or placebo- Part 1- Cohort 2
Treatment: Drugs - AK120 or placebo- Part 1- Cohort 3
Treatment: Drugs - AK120 or placebo- Part 1- Cohort 4
Treatment: Drugs - AK120 or placebo- Part 1- Cohort 5
Treatment: Drugs - AK120 or placebo- Part 2- Cohort 1
Treatment: Drugs - AK120 or placebo- Part 2- Cohort 2
Treatment: Drugs - AK120 or placebo- Part 2- Cohort 3
Treatment: Drugs - AK120 or placebo- Part 2- Cohort 4

Experimental: Part 1:15mg cohort - Single dose of 15mg AK120 or placebo is administered subcutaneously to healthy subjects.

Experimental: Part 1: 50mg cohort - Single dose of 50mg AK120 or placebo is administered subcutaneously to healthy subjects.

Experimental: Part 1: 150mg cohort - Single dose of 150mg AK120 or placebo is administered subcutaneously to healthy subjects.

Experimental: Part 1: 300 mg cohort - Single dose of 300mg AK120 or placebo is administered subcutaneously to healthy subjects.

Experimental: Part 1: 600 mg cohort - Single dose of 600mg AK120 or placebo is administered subcutaneously to healthy subjects.

Experimental: Part 2: low dose cohort - Multiple low doses of AK120 or placebo are administered subcutaneously to subjects with moderate- to- severe atopic dermatitis.

Experimental: Part 2: medium dose cohort - Multiple medium doses of AK120 or placebo are administered subcutaneously to subjects with moderate- to- severe atopic dermatitis.

Experimental: Part 2: high dose cohort - Multiple high doses of AK120 or placebo are administered subcutaneously to subjects with moderate- to- severe atopic dermatitis.

Experimental: Part 2: Loading dose cohort - A loading dose followed by multiple high doses of AK120 or placebo are administered subcutaneously to subjects with moderate- to- severe atopic dermatitis.


Treatment: Drugs: AK120 or placebo- Part 1- Cohort 1
Single dose of 15mg AK120 or placebo is administered subcutaneously to healthy subjects

Treatment: Drugs: AK120 or placebo- Part 1- Cohort 2
Single dose of 50mg AK120 or placebo is administered subcutaneously to healthy subjects

Treatment: Drugs: AK120 or placebo- Part 1- Cohort 3
Single dose of 150mg AK120 or placebo is administered subcutaneously to healthy subjects

Treatment: Drugs: AK120 or placebo- Part 1- Cohort 4
Single dose of 300mg AK120 or placebo is administered subcutaneously to healthy subjects

Treatment: Drugs: AK120 or placebo- Part 1- Cohort 5
Single dose of 600mg AK120 or placebo is administered subcutaneously to healthy subjects

Treatment: Drugs: AK120 or placebo- Part 2- Cohort 1
Multiple low doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis

Treatment: Drugs: AK120 or placebo- Part 2- Cohort 2
Multiple medium doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis

Treatment: Drugs: AK120 or placebo- Part 2- Cohort 3
Multiple high doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis

Treatment: Drugs: AK120 or placebo- Part 2- Cohort 4
Multiple high doses of AK120 or placebo are administered subcutaneously as a bi-weekly dose for a total of three doses to subjects with moderate-to-severe atopic dermatitis.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events(AEs)/serious adverse events(SAEs)
Timepoint [1] 0 0
From signing of informed consent through through 12 weeks post-dose
Secondary outcome [1] 0 0
Thymus and activation regulated chemokine (TARC)/Chemokine Ligand 17(CCL17)
Timepoint [1] 0 0
From baseline through 12 weeks post-dose
Secondary outcome [2] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [2] 0 0
From baseline through 12 weeks post-dose
Secondary outcome [3] 0 0
Area under the concentration-time curve (AUC)
Timepoint [3] 0 0
From baseline through 12 weeks postdose
Secondary outcome [4] 0 0
Anti-drug antibodies(ADAs)
Timepoint [4] 0 0
From baseline through 12 weeks postdose
Secondary outcome [5] 0 0
Investigator global assessment (IGA) (part 2)
Timepoint [5] 0 0
From baseline through 12 weeks postdose
Secondary outcome [6] 0 0
Pruritus-Numeric Rating Scale (P-NRS) (part 2)
Timepoint [6] 0 0
From baseline through 12 weeks postdose
Secondary outcome [7] 0 0
Change from baseline in Eczema Area and Severity Index (EASI) score(part 2)
Timepoint [7] 0 0
From baseline through 12 weeks postdose
Secondary outcome [8] 0 0
Change from baseline in body surface area (BSA) of AD involvement. (part 2)
Timepoint [8] 0 0
From baseline through 12 weeks postdose

Eligibility
Key inclusion criteria
Major

Subjects must meet all the following inclusion criteria (as applicable) to be eligible for participation in this study:

Part 1:

1. Willing and able to understand and sign an Informed Consent Form (ICF).
2. Women or men between 18 and 55 years of age, inclusive, at screening.
3. Must have a calculated body mass index within 18.0 to 30.0 kg/m2 (inclusive) at screening, and a total body weight =50 kg for men or =45 kg for women at screening and Day -1 before randomization.
4. Women of childbearing potential who are sexually active must use one of the permitted methods of contraception from screening until at least 180 days after dosing of study medication.
5. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use an effective method of contraception from Day 1 through 180 days after dosing of study medication.
6. Must, in the opinion of the Investigator, be in good general health based upon medical history, physical examination (including vital signs), and 12-lead ECG; and clinical laboratory tests

Part 2:

1. Male or female, aged 18 to 65 years (inclusive) at time of Screening.
2. Chronic atopic dermatitis (AD) diagnosed by the revised Hanifin and Rajka criteria that has been present for at least 1 year before the Screening visit.
3. EASI score =12 at the screening and baseline visits.
4. IGA score =3 at the screening and baseline visits.
5. BSA of AD involvement =10% at the screening and baseline visits.
6. History of an inadequate response or medically inappropriate use of topical drug treatment, in the judgment of the Investigator, to AD treatment with a topical regimen of corticosteroids, phosphodiesterase inhibitors or calcineurin inhibitors or with phototherapy within 6 months of the Screening visit.
7. Subjects must be applying stable doses of an additive-free, basic bland emollient twice daily for at least 7 days before the baseline visit.

Major
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects who meet any of the following exclusion criteria will not be enrolled in this study:

Part 1:

1. Clinically significant clinical safety laboratory result, or blood pressure or electrocardiogram (ECG) abnormalities.
2. Current acute infection or history of acute infection within 7 days prior to receipt of the study drug.
3. Have a recent history of conjunctivitis or keratitis within 6 months prior to screening.
4. History or complications of tuberculosis, or evidence of latent tuberculosis by QuantiFERON®-TB Gold screening.
5. Are positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV) at screening.

Part 2:

1. The washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/immunomodulating, biologics, phototherapy, Chinese medicine,anti-infective agents) is inadequate.
2. 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.
3. History of exposure to active TB, and/or history or current evidence of TB infection; and/or Chest X-ray showed old TB lesions at Screening or within 3 months before the Screening visit ..
4. Positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody with positive hepatitis C virus (HCV) RNA polymerase chain reaction; positive HIV serology at screening.
5. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
6. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit

Study design
Purpose of the study
Other
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 analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/10/2021
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Emeritus Sydney - Botany
Recruitment hospital [2] 0 0
Emeritus Melbourne - Camberwell
Recruitment hospital [3] 0 0
CMAX Clinical Research - Adelaide
Recruitment hospital [4] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [5] 0 0
Peninsula Specialist Centre - Kippa-Ring
Recruitment hospital [6] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
3145 - Camberwell
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- East Melbourne
Recruitment postcode(s) [5] 0 0
- Kippa-Ring
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Havelock North
Country [4] 0 0
New Zealand
State/province [4] 0 0
Tauranga
Country [5] 0 0
New Zealand
State/province [5] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04256174