Atopic DermatitisPhase 3ADaggioNCT07479615
A Study to Evaluate the Efficacy and Safety of MG-K10 in Participants Who Have Atopic Dermatitis
A Phase 3 study testing MG-K10 Humanized Monoclonal Antibody Injection in people with Atopic Dermatitis and Atopic Eczema, run by Shanghai Mabgeek Biotech.Co.Ltd.
Trial summary
Rationale (What is the reason for this study?) Atopic dermatitis (AD) is a condition that makes the skin dry and itchy and is the most common skin condition that causes redness and irritation. The exact cause of AD is unclear but genetic and environmental factors are believed to play a role. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis, Atopic Eczema
- What is being tested?
- MG-K10 Humanized Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to Jan 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: ≥12 years, both males and females.
- Diagnosed with AD (according to the 2014 American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit, and meeting the following conditions:
- Within 6 months prior to the screening visit, the patient has shown an insufficient response to topical medication or is medically unsuitable for topical treatment (e.g., significant side effects or safety risks).
- Participants should start a stable dose of moisturizer from the signing of ICF, apply a moisturizer twice daily for at least 7 consecutive days prior to randomization and continue using it throughout the study period.
- Women of childbearing age have a negative blood pregnancy test result during the screening period.
- Participants and their partners agree to use effective contraception from the time of signing the Informed Consent Form (ICF) until 6 months after the end of treatment ; no donation or freezing of germ cells is allowed from the time of signing the ICF until 6 months after the end of treatment.
- The participant voluntarily signs the ICF and can comply with all required visits and study-related procedures outlined in the protocol.
- For participants ≥ 12 and < 18 years of age at Screening Visit: Parent or legal guardian, as required, has voluntarily signed and dated an informed consent form, approved by an IEC, after the nature of the stud has been explained and the participant's parent or legal guardian has had the opportunity to ask questions.
Who cannot join
- Body weight < 30 kilograms (kg).
- The participant currently has a diagnosis of another active skin disease that may affect AD evaluation (e.g., psoriasis or lupus erythematosus).
- Known allergies to any component of the investigational drug.
- The participant cannot tolerate venipuncture or have a history of needle or blood phobia.
- The participant has comorbidities that may require systemic steroid therapy, other intervention measures, or require active and frequent monitoring.
- Those with significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematologic, neurologic, and psychiatric disorders that are unstable or not well controlled and are considered clinically significant by the investigator.
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- Participants with ocular diseases deemed unsuitable for study entry by the investigator, such as a history of atopic keratoconjunctivitis involving the cornea.
- Participants are planning to undergo major surgery during the study period, including inpatient and outpatient surgeries.
- Patients with malignant tumors within 5 years
- Participants with any of the following conditions within the related timeline:
- Use of biologics
- Use of targeted inhibitors (e.g., JAK inhibitors), systemic corticosteroids, cyclosporine, or other immunosuppressants
- Use of topical treatments for AD
- Receipt of allergen-specific immunotherapy
- Vaccination with live or attenuated live vaccines
- Participation in another clinical drug study
- Previous use of interleukin-4 receptor alpha (IL-4Rα) or interleukin-13 (IL-13) monoclonal antibody drugs
- Received systemic (oral or intravenous) antibacterial, antiviral, or antifungal treatment within 4 weeks prior to randomization.
- Evidence of active tuberculosis, or previous evidence of active tuberculosis without documented adequate treatment
- Diagnosis of active parasitic infection; suspected parasitic infection or high risk of infection unless clinical and (if necessary) laboratory evaluations have ruled out active infection prior to randomization.
- Laboratory results at screening showing any of the abnormalities
- Abnormal 12-lead electrocardiogram (ECG) at screening
- Active hepatitis at screening, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with hepatitis B virus DNA (HBV-DNA) positive, or positive for hepatitis C virus (HCV) antibodies with HCV RNA positive.
- History of human immunodeficiency virus (HIV) infection, or positive for HIV antibodies at screening
- Positive for Treponema pallidum antibodies (TP-Ab) at screening, except if rapid plasma reagin (RPR) or Toluidine Red Unheated Serum Test (TRUST) results are negative
- History of illicit drug use, drug abuse, or excessive alcohol consumption
- Women who are breastfeeding, pregnant, or planning to become pregnant or breastfeed during the study period.
- Any other conditions that the investigator considers inappropriate for study participation.
- -
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 Phase III Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Adult and Adolescent Patients With Moderate To-Severe Atopic Dermatitis
Rationale (What is the reason for this study?) Atopic dermatitis (AD) is a condition that makes the skin dry and itchy and is the most common skin condition that causes redness and irritation.
The exact cause of AD is unclear but genetic and environmental factors are believed to play a role. Common treatment options for participants with AD include basic skin care, medicine that is applied to the skin, and medicine that works in more than one part of the body. Typically, these treatment options work for participants with AD but some have skin lesions (skin sores or damaged skin) over large areas of the body and do not see an improvement in their AD symptoms. MG-K10 has been shown to be effective in treating participants with moderate-to-severeatopic dermatitis in Phase 2 studies (Chaoying Gu et al.2025) and has already completed a Phase 3 clinical study for adults in China. This study aims to evaluate the efficacy and safety of MG-K10 in the adolenscents and adults with moderate-to-severeatopic dermatitis in global population.
Read more
Objectives (goals of the study) and Endpoints (how goals are measured) Check how MG-K10 treatment affects atopic dermatitis Study doctors will look at the safety of MG-K10 and if any side effects are reported by participants when they take it.
Check how the body processes MG-K10 Check how MG-K10 affects the biomarkers of effect Check how the body's immune system (the body's defense system) reacts to MG-K10
- Conditions
- Atopic Dermatitis, Atopic Eczema
- Being tested
- MG-K10 Humanized Monoclonal Antibody Injection
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG-K10 Humanized Monoclonal Antibody InjectionBiological
MG-K10 Humanized Monoclonal Antibody Injection
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | After W16 patients will be re-randomize to:
1. MG-K10 Humanized Monoclonal Antibody Injection for responder Q4W
2. MG-K10 Humanized Monoclonal Antibody Injection for responder Q8W
3. Placebo Injection for responder Q4W
4. MG-K10 Humanized Monoclonal Antibody Injection for non-responder Q4W Receives: Biological: MG-K10 Humanized Monoclonal Antibody Injection |
| Placebo group: | Placebo comparator | After W16 patients will be re-randomize to:
MG-K10 Humanized Monoclonal Antibody Injection Q4W Receives: Biological: MG-K10 Humanized Monoclonal Antibody Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of MG K10 monotherapy compared to placebo in adults and adolescents with moderate to severe atopic dermatitis (AD).
Proportion of participants with EASI 75
Measured: From baseline (D1) to 60 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (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 Shanghai Mabgeek Biotech.Co.LtdThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479615
- Sponsor's protocol ID
- MG-K10-AD-202
- Acronym
- ADaggio
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Adult and Adolescent Patients With Moderate To-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07479615
- Acronym / sponsor ID
- ADaggio / MG-K10-AD-202
- Conditions
- Atopic Dermatitis, Atopic Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 18 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.
Rationale (What is the reason for this study?) Atopic dermatitis (AD) is a condition that makes the skin dry and itchy and is the most common skin condition that causes redness and irritation.
The exact cause of AD is unclear but genetic and environmental factors are believed to play a role. Common treatment options for participants with AD include basic skin care, medicine that is applied to the skin, and medicine that works in more than one part of the body. Typically, these treatment options work for participants with AD but some have skin lesions (skin sores or damaged skin) over large areas of the body and do not see an improvement in their AD symptoms. MG-K10 has been shown to be effective in treating participants with moderate-to-severeatopic dermatitis in Phase 2 studies (Chaoying Gu et al.2025) and has already completed a Phase 3 clinical study for adults in China. This study aims to evaluate the efficacy and safety of MG-K10 in the adolenscents and adults with moderate-to-severeatopic dermatitis in global population.
Objectives (goals of the study) and Endpoints (how goals are measured) Check how MG-K10 treatment affects atopic dermatitis Study doctors will look at the safety of MG-K10 and if any side effects are reported by participants when they take it.
Check how the body processes MG-K10 Check how MG-K10 affects the biomarkers of effect Check how the body's immune system (the body's defense system) reacts to MG-K10
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Biological: MG-K10 Humanized Monoclonal Antibody InjectionAfter W16 patients will be re-randomize to: 1. MG-K10 Humanized Monoclonal Antibody Injection for responder Q4W 2. MG-K10 Humanized Monoclonal Antibody Injection for responder Q8W 3. Placebo Injection for responder Q4W 4. MG-K10 Humanized Monoclonal Antibody Injection for non-responder Q4W |
| Placebo group: | Placebo comparator | Biological: MG-K10 Humanized Monoclonal Antibody InjectionAfter W16 patients will be re-randomize to: MG-K10 Humanized Monoclonal Antibody Injection Q4W |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age: ≥12 years, both males and females.
- Diagnosed with AD (according to the 2014 American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit, and meeting the following conditions:
- Within 6 months prior to the screening visit, the patient has shown an insufficient response to topical medication or is medically unsuitable for topical treatment (e.g., significant side effects or safety risks).
- Participants should start a stable dose of moisturizer from the signing of ICF, apply a moisturizer twice daily for at least 7 consecutive days prior to randomization and continue using it throughout the study period.
- Women of childbearing age have a negative blood pregnancy test result during the screening period.
Key exclusion criteria (29 listed)
- Body weight < 30 kilograms (kg).
- The participant currently has a diagnosis of another active skin disease that may affect AD evaluation (e.g., psoriasis or lupus erythematosus).
- Known allergies to any component of the investigational drug.
- The participant cannot tolerate venipuncture or have a history of needle or blood phobia.
- The participant has comorbidities that may require systemic steroid therapy, other intervention measures, or require active and frequent monitoring.
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 |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody InjectionMG-K10 Humanized Monoclonal Antibody Injection | Biological | MG-K10 Humanized Monoclonal Antibody Injection, Placebo group: |
Primary outcome
To evaluate the efficacy of MG K10 monotherapy compared to placebo in adults and adolescents with moderate to severe atopic dermatitis (AD).
Time frame: From baseline (D1) to 60 week
Proportion of participants with EASI 75
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 18 Mar 2026.
- Individual participant dataSharing planned: Yes
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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 3 study testing MG-K10 Humanized Monoclonal Antibody Injection in people with Atopic Dermatitis and Atopic Eczema, run by Shanghai Mabgeek Biotech.Co.Ltd.
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 8 inclusion and 29 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 18 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 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 Yunfei Xia (+86 021-51371305, yunfei.xia@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of MG K10 monotherapy compared to placebo in adults and adolescents with moderate to severe atopic dermatitis (AD). (time frame: From baseline (D1) to 60 week). 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 18 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.