Atopic DermatitisPhase 3NCT06767540
A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis
A Phase 3 study of Atopic Dermatitis, run by Akeso at 28 sites in China.
Trial summary
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Atopic Dermatitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 28 sitesChina
- Study dates
- 23 Jan 2025to 10 Jul 2027
- Phase
- Phase 3
- 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.
- AD diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
- Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.
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 4 weeks or 5 halflives 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
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
China28 sites
Peking University People's Hospital
Beijing, Beijing Municipality
Hunan Children's Hospital
Changsha, Hunan
XiangYa Hospital CentralSouth University
Changsha, Hunan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Dongguan People's Hospital
Dongguan, Guangdong
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Jiangmen Central Hospital
Jiangmen, Guangdong
The First Hospital of Jiaxing
Jiaxing, Zhejiang
Shandong Provincial Dermatology Hospital
Jinan, Shandong
Jining First People's Hospital
Jining, Shandong
Jinzhou Central Hospital
Jinzhou, Hubei
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Liuzhou Worker's Hospital
Liuzhou, Guangxi
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong
Tongji Hospital
Wuhan, Hubei
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
The Third People's Hospital of Zhuhai
Zhuhai, Guangdong
About this study
Official title: A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.
Read the detailed description
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- Placebo
- 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 Q2W until week 46.
placeboDrug
placebo subcutaneous injection Q3W until week 45.
| Study group | Role | What they receive |
|---|---|---|
| AK120 600mg every two weeks (Q2W) subcutaneous injection | Experimental | AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46. Receives: Drug: Placebo |
| AK120 600mg every three weeks (Q3W) subcutaneous injection | Experimental | AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75
At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity).
Measured: at week 18 （day 127)
Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points
At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe).
Measured: at week 18 （day 127)
Secondary outcomes (4)
Percentage change in affected Body Surface Area (BSA)
Percentage change in BSA from baseline.
Measured: week 0 to week 52
percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
percentage change of P-NRS scores from baseline at each visit. The scale ranging from 0 to 10 ( 0=no itch; 10=worst itch imaginable).
Measured: week 0 to week 52
Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score
Percentage changes in the CDLQI score compared to baseline at each visit. The total score range from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.
Measured: week 0 to week 52
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 0 to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start23 Jan 2025 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Jul 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767540
- Sponsor's protocol ID
- AK120-302
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 10 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents
- ClinicalTrials.gov ID
- NCT06767540
- Acronym / sponsor ID
- AK120-302
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (estimated)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 10 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 randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.
Detailed description
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK120 600mg every two weeks (Q2W) subcutaneous injection | Experimental | Drug: PlaceboAK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46. |
| AK120 600mg every three weeks (Q3W) subcutaneous injection | Experimental | Drug: placeboAK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45. |
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.
- AD diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
- Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.
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 4 weeks or 5 halflives 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 |
|---|---|---|
| Placeboplacebo subcutaneous injection Q2W until week 46. | Drug | AK120 600mg every two weeks (Q2W) subcutaneous injection |
| placeboplacebo subcutaneous injection Q3W until week 45. | Drug | AK120 600mg every three weeks (Q3W) subcutaneous injection |
Primary outcome
Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75
Time frame: at week 18 （day 127)
At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity).
Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points
Time frame: at week 18 （day 127)
At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe).
4 secondary outcomes
Percentage change in affected Body Surface Area (BSA)
Time frame: week 0 to week 52
percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
Time frame: week 0 to week 52
Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score
Time frame: week 0 to week 52
Incidence of Adverse Events (AE)
Time frame: week 0 to week 52
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 10 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.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Atopic Dermatitis, run by Akeso at 28 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 10 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 28 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75 (time frame: at week 18 （day 127)). The study lists 2 primary outcomes in all. 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 10 Jan 2025.