Dermatitis, AtopicPhase 3NCT07540442
A Phase III Study of MG-K10 in Adolescents With Moderate-to-Severe Atopic Dermatitis
A Phase 3 study testing MG-K10 Injection (Humanized Monoclonal Antibody) in people with Dermatitis, Atopic, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD) Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- MG-K10 Injection (Humanized Monoclonal Antibody)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2026to 9 Nov 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Atopic Dermatitis (AD) per American Academy of Dermatology (2014) criteria for ≥6 months;
- Eczema Area and Severity Index (EASI) ≥16;
- Investigator's Global Assessment (IGA) ≥3;
- Body Surface Area (BSA) involvement ≥10%;
- Peak Pruritus Numerical Rating Scale (NRS) weekly average ≥4;
- Inadequate response to topical treatments within 6 months or medically inadvisable to use topical treatments.
Who cannot join
- Inability to tolerate venipuncture, or a history of needle phobia or hematophobia;
- Inability to receive subcutaneous injections, such as patients currently receiving anticoagulant therapy, or those with known bleeding disorders or idiopathic thrombocytopenic purpura;
- Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion;
- Concurrent serious diseases including, but not limited to, cardiovascular, metabolic, or neurological diseases, which, in the opinion of the investigator, render the subject unsuitable for immunosuppressive therapy;
- History of parasitic infection within 6 months prior to screening;
- Planned major surgery during the study period;
Show all 15Show fewer
- Prior or concomitant treatments meeting any of the following:
- Use of biologics within 10 weeks prior to randomization or within 5 half-lives (whichever is longer)
- Use of targeted inhibitors (e.g., JAK inhibitors), systemic glucocorticoids, cyclosporine, or other immunosuppressants (e.g., methotrexate, MMF, azathioprine), phosphodiesterase-4 (PDE4) inhibitors, phototherapy (UV), or systemic Chinese herbal medicine for AD within 4 weeks prior to randomization
- Use of topical treatments for AD (e.g., topical glucocorticoids, topical calcineurin inhibitors, antibiotic combination creams, or topical Chinese herbal medicine) within 2 weeks prior to randomization
- Receipt of live or attenuated vaccines within 3 months prior to randomization or plans to receive such vaccines during the study
- Participation in other clinical trials within 3 months or 5 half-lives (whichever is longer) prior to randomization, or plans to participate in other clinical trials during the study period
- Systemic anti-infective therapy (oral or intravenous antibacterial, antiviral, or antifungal) within 4 weeks prior to randomization, or current acute or subacute infection indicated by symptoms, signs, or laboratory abnormalities
- History of alcohol or drug abuse within 6 months prior to screening; Known allergy or intolerance to any component of the investigational product.
- Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital Of China Medical University
Shenyang
Xinghua Gao, MD, 024-83283391, gaobarry@hotmail.com
About this study
Official title: Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MG-K10 (a Humanized Monoclonal Antibody Injection) in Adolescents With Moderate-to-Severe Atopic Dermatitis
This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)
- Conditions
- Dermatitis, Atopic
- Being tested
- MG-K10 Injection (Humanized Monoclonal Antibody), Placebo for MG-K10
- 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 Injection (Humanized Monoclonal Antibody)Drug
loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52
Placebo for MG-K10Drug
Initial loading dose (SC), then single dose Q2W through Week 52
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 | Experimental | loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52 Receives: Drug: MG-K10 Injection (Humanized Monoclonal Antibody) |
| Placebo | Placebo comparator | Initial loading dose (SC), then single dose Q2W through Week 52 Receives: Drug: Placebo for MG-K10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline )
Measured: week 16
Proportion of participants achieving IGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline
Measured: week 16
Secondary outcomes (4)
Change in Peak Pruritus NRS
Measured: Baseline to week 52
Proportion of participants achieving EASI-50, EASI-90
Measured: Baseline to week 52
Change and percent change from baseline in the Quality of Life Score: CDLQI and EQ-5D-Y-3L scores
Measured: Baseline to week 52
Incidence in adverse events
Measured: Baseline 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 posted20 Apr 2026
- Study start17 Apr 2026 (estimated)
- Primary completion5 Jan 2027 (estimated)
- Study completion9 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
- NCT07540442
- Sponsor's protocol ID
- MG-K10-AD-006
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MG-K10 (a Humanized Monoclonal Antibody Injection) in Adolescents With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07540442
- Acronym / sponsor ID
- MG-K10-AD-006
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (estimated)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 9 Nov 2027 (estimated)
- First posted
- 20 Apr 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, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)
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 |
|---|---|---|
| MG-K10 | Experimental | Drug: MG-K10 Injection (Humanized Monoclonal Antibody)loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52 |
| Placebo | Placebo comparator | Drug: Placebo for MG-K10Initial loading dose (SC), then single dose Q2W through Week 52 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of Atopic Dermatitis (AD) per American Academy of Dermatology (2014) criteria for ≥6 months;
- Eczema Area and Severity Index (EASI) ≥16;
- Investigator's Global Assessment (IGA) ≥3;
- Body Surface Area (BSA) involvement ≥10%;
- Peak Pruritus Numerical Rating Scale (NRS) weekly average ≥4;
Key exclusion criteria (15 listed)
- Inability to tolerate venipuncture, or a history of needle phobia or hematophobia;
- Inability to receive subcutaneous injections, such as patients currently receiving anticoagulant therapy, or those with known bleeding disorders or idiopathic thrombocytopenic purpura;
- Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion;
- Concurrent serious diseases including, but not limited to, cardiovascular, metabolic, or neurological diseases, which, in the opinion of the investigator, render the subject unsuitable for immunosuppressive therapy;
- History of parasitic infection within 6 months prior to screening;
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 Injection (Humanized Monoclonal Antibody)loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52 | Drug | MG-K10 |
| Placebo for MG-K10Initial loading dose (SC), then single dose Q2W through Week 52 | Drug | Placebo |
Primary outcome
Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline )
Time frame: week 16
Proportion of participants achieving IGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline
Time frame: week 16
4 secondary outcomes
Change in Peak Pruritus NRS
Time frame: Baseline to week 52
Proportion of participants achieving EASI-50, EASI-90
Time frame: Baseline to week 52
Change and percent change from baseline in the Quality of Life Score: CDLQI and EQ-5D-Y-3L scores
Time frame: Baseline to week 52
Incidence in adverse events
Time frame: Baseline 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 20 Apr 2026.
Related trials for Dermatitis, Atopic
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MG-K10 Injection (Humanized Monoclonal Antibody) in people with Dermatitis, Atopic, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site 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 6 inclusion and 15 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Xiaofeng Cai, bachelor (021-51371305, xiaofeng.cai@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline ) (time frame: week 16). 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 20 Apr 2026.