Atopic DermatitisPhase 3NCT06383468
A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing AK120 in people with Atopic Dermatitis, run by Akeso at 59 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 injection in the treatment of patients with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 420 participants
- Where
- 59 sitesChina
- Study dates
- 30 Apr 2024to 30 Jan 2026
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18≤75 years old.
- Atopic dermatitis (AD) diagnosed at least 1 year before screening.
- Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
- Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable
Who cannot join
- Acute onset of AD within the first 4 weeks of randomization.
- Have participated in any clinical research on AK120 in the past
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
- Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
- Received allergen specific immunotherapy within the 3 months before randomization.
- Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
China59 sites, 59 recruiting
- Recruiting
Baoji Central Hospital
Baoji, Shanxi
- Recruiting
Beijing Friendship Hospital Capital Medical University
Beijing, Beijing Municipality
- Recruiting
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Jiangsu
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin
- Recruiting
Changde First People's Hospital
Changde, Hunan
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Changzhou First People's Hospital
Changzhou, Jiangsu
- Recruiting
Chengde Medical College Affiliated Hospital
Chengde, Hebei
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
- Recruiting
Chongqing Three Gorges Medical College Affiliated People's Hospital
Chongqing, Chongqing Municipality
- Recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
- Recruiting
The First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
- Recruiting
Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital
Guangzhou, Guangdong
- Recruiting
Southern Medical University Southern Hospital
Guangzhou, Guangdong
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
- Recruiting
Hainan General Hospital
Haikou, Hainan
- Recruiting
Hainan Provincial Fifth People's Hospital
Haikou, Hainan
- Recruiting
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang
- Recruiting
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
- Recruiting
Harbin Medical University Affiliated Second Hospital
Harbin, Heilongjiang
- Recruiting
Heilongjiang Provincial Hospital
Harbin, Heilongjiang
- Recruiting
The First Affiliated Hospital of South China University
Hengyang, Hunan
- Recruiting
Inner Mongolia Medical University Affiliated Hospital
Hohhot, Inner Mongolia
- Recruiting
Jiaxing First People's Hospital
Jiaxing, Zhejiang
- Recruiting
Shandong Provincial Dermatology Hospital
Jinan, Shandong
- Recruiting
Shandong University Qilu Hospital
Jinan, Shandong
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
- Recruiting
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
- Recruiting
Ningbo First Hospital
Ningbo, Zhejiang
- Recruiting
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang
- Recruiting
Panjin Liaoyou Gemstone Flower Hospital
Panjin, Liaoning
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
- Recruiting
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality
- Recruiting
Yuebei People's hospital, Guangdong, China
Shaoguan, Guangdong
- Recruiting
Shenyang Integrated Traditional Chinese and Western Medicine Hospital
Shenyang, Liaoning
- Recruiting
Zhongyi Northeast International Hospital
Shenyang, Liaoning
- Recruiting
Shunde Hospital of Southern Medical University
Shunde, Guangdong
- Recruiting
Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality
- Recruiting
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang
- Recruiting
Wenzhou Medical University First Affiliated Hospital
Wenzhou, Zhejiang
- Recruiting
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei
- Recruiting
Tongji Hospital
Wuhan, Hubei
- Recruiting
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian
- Recruiting
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei
- Recruiting
Yancheng First People's Hospital
Yancheng, Jiangsu
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
- Recruiting
Guangdong Medical University Affiliated Hospital
Zhanjiang, Guangdong
- Recruiting
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu
About this study
Official title: a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.
Read the detailed description
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.
- 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
300mg Q2W subcutaneous injection thereafter until week 50.
| Study group | Role | What they receive |
|---|---|---|
| AK120 600mg/300mg | Experimental | AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50. Receives: Drug: AK120 |
| Placebo/AK120 600mg to 300mg | Placebo comparator | placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50. Receives: Drug: AK120 |
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
Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16.
Measured: at week 16
Secondary outcomes (1)
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16.
Measured: at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2026 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383468
- Sponsor's protocol ID
- AK120-301
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- 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 25 Apr 2024. 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 to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06383468
- Acronym / sponsor ID
- AK120-301
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 25 Apr 2024 (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 injection in the treatment of patients with moderate to severe atopic dermatitis.
Detailed description
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK120 600mg/300mg | Experimental | Drug: AK120AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50. |
| Placebo/AK120 600mg to 300mg | Placebo comparator | Drug: AK120placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects aged ≥18≤75 years old.
- Atopic dermatitis (AD) diagnosed at least 1 year before screening.
- Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
- Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable
Key exclusion criteria (7 listed)
- Acute onset of AD within the first 4 weeks of randomization.
- Have participated in any clinical research on AK120 in the past
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
- Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
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 |
|---|---|---|
| AK120300mg Q2W subcutaneous injection thereafter until week 50. | Drug | AK120 600mg/300mg, Placebo/AK120 600mg to 300mg |
Primary outcome
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Time frame: at week 16
Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16.
1 secondary outcome
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
Time frame: at week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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.
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK120 in people with Atopic Dermatitis, run by Akeso at 59 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 7 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 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 25 Apr 2024.