Atopic DermatitisPhase 2NCT06092762
A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing AK120 in people with Atopic Dermatitis, run by Akeso at 26 sites in China.
Trial summary
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects 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?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 26 sitesChina
- Study dates
- 6 Nov 2023to 13 Nov 2024
- 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 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 half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
- Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months
Who cannot join
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- 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)
- 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
26 sites in 1 country.
26 sites in 1 country
China26 sites
Baoji Central Hospital
Baoji, Shanxi
Air Force Medical Center
Beijing, Beijing Municipality
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing 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
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Ningbo No.2 Hospital
Ningbo, Zhejiang
Qingdao Municipal Hospital
Qingdao, Shandong
Shenzhen People's Hospital
Shenzhen, Guangdong
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Taiyuan Central Hospital
Taiyuan, Shanxi
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality
The first affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian
People Hospital of Xingtai
Xingtai, Hebei
Yancheng No.1 People's Hospital
Yancheng, Jiangsu
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang
About this study
Official title: a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
Read the detailed description
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 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
subcutaneous injection every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| AK120 300mg | Experimental | AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14. Receives: Drug: AK120 |
| AK120 450mg | Experimental | AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14. 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 0 to week 24
Secondary outcomes (6)
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Measured: at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50
Measured: at week 2/4/8/12/16 /20 and 24
Percentage change in (Eczema Area and Severity Index) EASI scores from baseline
Measured: at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
Measured: at week 2/4/8/12/16 /20 and 24
Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline
Measured: at week 2/4/8/12/16 /20 and 24
Percentage change in (affected body surface area) BSA score from baseline
Measured: at week 2/4/8/12/16 /20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start6 Nov 2023
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092762
- Sponsor's protocol ID
- AK120-206
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2023
- Last updated
- 25 Nov 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06092762
- Acronym / sponsor ID
- AK120-206
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 23 Oct 2023 (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 multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
Detailed description
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK120 300mg | Experimental | Drug: AK120AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14. |
| AK120 450mg | Experimental | Drug: AK120AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14. |
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 half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
- Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months
Key exclusion criteria (6 listed)
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- 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)
- 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.
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 |
|---|---|---|
| AK120subcutaneous injection every 2 weeks | Drug | AK120 300mg, AK120 450mg |
Primary outcome
Incidence of adverse events(AE)
Time frame: week 0 to week 24
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
6 secondary outcomes
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage change in (Eczema Area and Severity Index) EASI scores from baseline
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage change in (affected body surface area) BSA score from baseline
Time frame: at week 2/4/8/12/16 /20 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
26 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 26 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: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events(AE) (time frame: week 0 to week 24). 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 Nov 2024.