Atopic DermatitisPhase 2NCT06756126
A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD)
A Phase 2 study testing AK120 in people with Atopic Dermatitis, run by Akeso at 6 sites in China.
Trial summary
This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- AK120
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesChina
- Study dates
- 30 Dec 2024to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female subjects aged ≥12 <18 years old.
- Weight≥30kg at baseline.
- AD diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
Who cannot join
- Acute onset of AD in 4 weeks prior to enrollment.
- Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
- Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
- Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
- Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer).
- Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Hunan Pediatric Medical Union
Changsha, Hunan
Xiangya Hospital Central South University
Changsha, Hunan
Dongguan People's Hospital
Dongguan, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Ning Bo No.2 Hospital
Ningbo, Zhejiang
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong
About this study
Official title: A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD
This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis
Read the detailed description
This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- AK120
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK120Drug
AK120 subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| AK120 300mg every two weeks (Q2W) subcutaneous injection | Experimental | Subjects with heavy weight Receives: Drug: AK120 |
| AK120 300mg every three weeks (Q3W) subcutaneous injection | Experimental | Subjects with light weight Receives: Drug: AK120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events(AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: week -4 to week 16
Secondary outcomes (8)
PK evaluation: maximum plasma concentration (Cmax)
Assessment of Cmax after AK120 administration.
Measured: Baseline till last follow-up visit ( up to day 113)
PK evaluation: time to maximum plasma concentration (Tmax)
Assessment of Tmax after AK120 administration.
Measured: Baseline till last follow-up visit ( up to day 113)
PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17
Percentage change in TARC/CCL17 compared to baseline.
Measured: Baseline till last follow-up visit ( up to day 113)
Change in Eczema Area and Severity Index (EASI) scores
Percentage change in EASI scores from baseline.
Measured: week 0/2/4/8/12/16
Change in affected Body Surface Area (BSA) scores
Percentage change in BSA score from baseline.
Measured: week 0/2/4/8/12/16
Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)
Percentage of subjects who achieved IGA 0/1.
Measured: week 0/2/4/8/12/16
Change in Children's Dermatology Life Quality Index (CDLQI) scores
Percentage change in CDLQI score from baseline.
Measured: week 0/2/4/8/12/16
Change in Patient Oriented Eczema Measure (POEM) scores
Percentage change in POEM score from baseline.
Measured: week 0/2/4/8/12/16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start30 Dec 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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.
- More trials run by AkesoThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756126
- Sponsor's protocol ID
- AK120-208
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD
- ClinicalTrials.gov ID
- NCT06756126
- Acronym / sponsor ID
- AK120-208
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Jan 2025 (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 A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis
Detailed description
This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK120 300mg every two weeks (Q2W) subcutaneous injection | Experimental | Drug: AK120Subjects with heavy weight |
| AK120 300mg every three weeks (Q3W) subcutaneous injection | Experimental | Drug: AK120Subjects with light weight |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female subjects aged ≥12 <18 years old.
- Weight≥30kg at baseline.
- AD diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
Key exclusion criteria (6 listed)
- Acute onset of AD in 4 weeks prior to enrollment.
- Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
- Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
- Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
- Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer).
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 |
|---|---|---|
| AK120AK120 subcutaneous injection | Drug | AK120 300mg every three weeks (Q3W) subcutaneous injection, AK120 300mg every two weeks (Q2W) subcutaneous injection |
Primary outcome
Incidence of adverse events(AE)
Time frame: week -4 to week 16
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
8 secondary outcomes
PK evaluation: maximum plasma concentration (Cmax)
Time frame: Baseline till last follow-up visit ( up to day 113)
PK evaluation: time to maximum plasma concentration (Tmax)
Time frame: Baseline till last follow-up visit ( up to day 113)
PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17
Time frame: Baseline till last follow-up visit ( up to day 113)
Change in Eczema Area and Severity Index (EASI) scores
Time frame: week 0/2/4/8/12/16
Change in affected Body Surface Area (BSA) scores
Time frame: week 0/2/4/8/12/16
Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)
Time frame: week 0/2/4/8/12/16
Change in Children's Dermatology Life Quality Index (CDLQI) scores
Time frame: week 0/2/4/8/12/16
Change in Patient Oriented Eczema Measure (POEM) scores
Time frame: week 0/2/4/8/12/16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 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.
6 sites in 1 country: 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 Akeso at 6 sites in China.
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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoqin Wang (86 (0760) 8987 3999, global.trials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events(AE) (time frame: week -4 to 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 1 Jan 2025.