Moderate-to-Severe Atopic DermatitisPhase 2NCT07502222
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis
A Phase 2 study testing AK139 in people with Moderate-to-Severe Atopic Dermatitis, run by Akeso.
Trial summary
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 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
- Moderate-to-Severe Atopic Dermatitis
- What is being tested?
- AK139
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2026to 10 Jan 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study and voluntarily sign the ICF.
- Atopic dermatitis (AD) diagnosed at least 6 months before screening.
- Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline.
- A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.
- Inadequate response or intolerance to prior topical therapy for AD.
- The patients agree to use highly effective contraception methods from the moment of signing of the ICF to 90 days after the last dose of the investigational product.
Who cannot join
- Acute onset of AD within the first 4 weeks of randomization.
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy or other systemic therapies used for AD 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 12 weeks before randomization or during the study period.
- Received allergen specific immunotherapy within the 12 weeks before randomization.
- Have a history of allergies to any component of AK139 and/or severe allergic reactions to monoclonal antibodies.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate to Severe Atopic Dermatitis
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.
- Conditions
- Moderate-to-Severe Atopic Dermatitis
- Being tested
- AK139 and placebo, AK139, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK139 and placeboBiological
AK139 plus placebo regimen 1-subcutaneous injection.
AK139Biological
AK139 regimen 2-subcutaneous injection.
AK139 and placeboBiological
AK139 plus placebo regimen 3-subcutaneous injection.
AK139Biological
AK139 regimen 4-subcutaneous injection.
AK139 and placeboBiological
AK139 plus placebo regimen 5-subcutaneous injection.
AK139 and placeboBiological
AK139 plus placebo regimen 6-subcutaneous injection.
PlaceboBiological
Placebo-subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1: AK139 regimen 1 | Experimental | Not described Receives: Biological: AK139 and placebo |
| Part 1: AK139 regimen 2 | Experimental | Not described Receives: Biological: AK139 |
| Part 1: AK139 regimen 3 | Experimental | Not described Receives: Biological: AK139 and placebo |
| Part 1: AK139 regimen 4 | Experimental | Not described Receives: Biological: AK139 |
| Part 2: AK139 regimen 5 | Experimental | Not described Receives: Biological: AK139 and placebo |
| Part 2: AK139 regimen 6 | Experimental | Not described Receives: Biological: AK139 and placebo |
| Part 2: Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity grading of Adverse Events (AE)(applicable to Part 1)
Measured: Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group).
Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2)
Measured: at week 16
Secondary outcomes (4)
Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline
Measured: Up to Week 24
Percentage change in affected Body Surface Area (BSA)
Measured: Up to week 24
Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
Measured: Up to week 24
Percentage changes in the Dermatology Life Quality Index (DLQI) score
Measured: Up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start7 Apr 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completion10 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-Severe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502222
- Sponsor's protocol ID
- AK139-205
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 30 Mar 2026
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07502222
- Acronym / sponsor ID
- AK139-205
- Conditions
- Moderate-to-Severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- 10 Jan 2028 (estimated)
- First posted
- 30 Mar 2026 (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 phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: AK139 regimen 1 | Experimental | Biological: AK139 and placebo |
| Part 1: AK139 regimen 2 | Experimental | Biological: AK139 |
| Part 1: AK139 regimen 3 | Experimental | Biological: AK139 and placebo |
| Part 1: AK139 regimen 4 | Experimental | Biological: AK139 |
| Part 2: AK139 regimen 5 | Experimental | Biological: AK139 and placebo |
| Part 2: AK139 regimen 6 | Experimental | Biological: AK139 and placebo |
| Part 2: Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand the study and voluntarily sign the ICF.
- Atopic dermatitis (AD) diagnosed at least 6 months before screening.
- Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline.
- A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.
- Inadequate response or intolerance to prior topical therapy for AD.
Key exclusion criteria (6 listed)
- Acute onset of AD within the first 4 weeks of randomization.
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy or other systemic therapies used for AD 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 12 weeks before randomization or during the study period.
- Received allergen specific immunotherapy within the 12 weeks 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 |
|---|---|---|
| AK139 and placeboAK139 plus placebo regimen 1-subcutaneous injection. | Biological | Part 1: AK139 regimen 1 |
| AK139AK139 regimen 2-subcutaneous injection. | Biological | Part 1: AK139 regimen 2 |
| AK139 and placeboAK139 plus placebo regimen 3-subcutaneous injection. | Biological | Part 1: AK139 regimen 3 |
| AK139AK139 regimen 4-subcutaneous injection. | Biological | Part 1: AK139 regimen 4 |
| AK139 and placeboAK139 plus placebo regimen 5-subcutaneous injection. | Biological | Part 2: AK139 regimen 5 |
| AK139 and placeboAK139 plus placebo regimen 6-subcutaneous injection. | Biological | Part 2: AK139 regimen 6 |
| PlaceboPlacebo-subcutaneous injection | Biological | Part 2: Placebo |
Primary outcome
Incidence and severity grading of Adverse Events (AE)(applicable to Part 1)
Time frame: Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group).
Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2)
Time frame: at week 16
4 secondary outcomes
Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline
Time frame: Up to Week 24
Percentage change in affected Body Surface Area (BSA)
Time frame: Up to week 24
Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
Time frame: Up to week 24
Percentage changes in the Dermatology Life Quality Index (DLQI) score
Time frame: Up to week 24
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 30 Mar 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK139 in people with Moderate-to-Severe Atopic Dermatitis, run by Akeso.
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 6 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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 and severity grading of Adverse Events (AE)(applicable to Part 1) (time frame: Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group).). 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 30 Mar 2026.