Atopic DermatitisPhase 2NCT05048056
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing AK120 in people with Atopic Dermatitis, run by Akesobio Australia Pty Ltd at 24 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- AK120
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 24 sitesin 3 countries
- Study dates
- 30 Sep 2021to 17 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, over the age of 18
- Chronic atopic dermatitis (AD) diagnosed at least 1 year.
- 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.
- Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.
Who cannot join
- Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents).
- History of exposure to active TB, and/or history or current evidence of TB infection.
- Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
- Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
- History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
- 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.
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States16 sites
AkesoBio Investigative Site 2010
Canoga Park, California, 91303
AkesoBio Investigative Site 2009
Hialeah, Florida, 33016
AkesoBio Investigative Site 2001
Hollywood, Florida, 33021
AkesoBio Investigative Site 2004
Houston, Texas, 77065
AkesoBio Investigative Site 2018
Houston, Texas, 77074
AkesoBio Investigative Site 2015
Las Vegas, Nevada, 89145
AkesoBio Investigative Site 2003
Little Rock, Arkansas, 72204
AkesoBio Investigative Site 2011
Miami, Florida, 33155
AkesoBio Investigative Site 2005
Rapid City, South Dakota, 57702
AkesoBio Investigative Site 2022
Ridgeland, Mississippi, 39157
AkesoBio Investigative Site 2021
San Diego, California, 92119
AkesoBio Investigative Site 2023
San Diego, California, 92120
AkesoBio Investigative Site 2017
San Francisco, California, 94127
AkesoBio Investigative Site 2020
Sherman Oaks, California, 91043
AkesoBio Investigative Site 2013
Spartanburg, South Carolina, 29303
AkesoBio Investigative Site 2002
Weston, Florida, 33331
New Zealand5 sites
AkesoBio Investigative Site 4003
Auckland, 0626
AkesoBio Investigative Site 4001
Auckland, 1010
AkesoBio Investigative Site 4005
Christchurch, 8013
AkesoBio Investigative Site 4004
Hamilton, 3204
AkesoBio Investigative Site 4004
Wellington, 6242
Australia3 sites
AkesoBio Investigative Site 3001
Camberwell, Victoria, 3145
AkesoBio Investigative Site 3003
Sydney, New South Wales, 2145
AkesoBio Investigative Site 3002
Woolloongabba, Queensland, 4102
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Placebo, AK120
- Keywords
- Atopic Dermatitis, Monoclonal Antibodies
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
AK120Drug
AK120 Regimen 1- subcutaneous injection every 2 weeks.
AK120Drug
AK120 Regimen 2- subcutaneous injection every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| AK120 Regimen 1 | Experimental | AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks. Receives: Drug: AK120 |
| AK120 Regimen 2 | Experimental | AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks. Receives: Drug: AK120 |
| Placebo to AK120 | Experimental | Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation Receives: Drug: Placebo; Drug: AK120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
Measured: At week 16
Secondary outcomes (9)
Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)
Measured: At week 16
Change in SCORing Atopic Dermatitis (SCORAD)
Measured: Baseline to Week 38
Change in Pruritus-Numerical Rating Scale (P-NRS)
Measured: Baseline to Week 38
Change in Body Surface Area (BSA) of AD involvement
Measured: Baseline to Week 38
Change in Patient Oriented Eczema Measure (POEM)
Measured: Baseline to Week 38
Individual subject AK120 concentrations in serum at different time points after AK120 administration
Measured: Baseline to Week 38
Change in pharmacodynamics studies TARC/CCL17 and IgE
Measured: Baseline to week 24
Anti-drug antibodies(ADAs)
Measured: Baseline to Week 38
Adverse events(AEs)/serious adverse events(SAEs)
Measured: Baseline to Week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start30 Sep 2021
- Primary completion17 May 2023
- Study completion17 May 2023
Why it stopped: Clinical study and development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akesobio Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048056
- Sponsor's protocol ID
- AK120-203
- Status last verified
- Feb 2025
- First submitted
- 9 Sep 2021
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05048056
- Acronym / sponsor ID
- AK120-203
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Monoclonal Antibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical study and development strategy adjustment
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Akesobio Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AK120 Regimen 1 | Experimental | Drug: AK120AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks. |
| AK120 Regimen 2 | Experimental | Drug: AK120AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks. |
| Placebo to AK120 | Experimental | Drug: Placebo, Drug: AK120Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, over the age of 18
- Chronic atopic dermatitis (AD) diagnosed at least 1 year.
- 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.
- Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.
Key exclusion criteria (6 listed)
- Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents).
- History of exposure to active TB, and/or history or current evidence of TB infection.
- Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
- Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
- History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1 | Drug | Placebo to AK120 |
| AK120AK120 Regimen 1- subcutaneous injection every 2 weeks. | Drug | AK120 Regimen 1, Placebo to AK120 |
| AK120AK120 Regimen 2- subcutaneous injection every 2 weeks | Drug | AK120 Regimen 2 |
Primary outcome
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
Time frame: At week 16
9 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Clinical study and development strategy adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK120 in people with Atopic Dermatitis, run by Akesobio Australia Pty Ltd at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Clinical study and development strategy adjustment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response (time frame: At week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.