Atopic Dermatitis (AD)Phase 2MG-K10NCT07103174
A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis
A Phase 2 study of Atopic Dermatitis (AD), run by Shanghai Mabgeek Biotech.Co.Ltd at 2 sites in China.
Trial summary
This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jun 2025to 29 Apr 2026
- 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
- AD patients diagnosed in accordance with the consensus criteria of the American Academy of Dermatology (2014) had a history of AD or eczema diagnosis of ≥1 year
- The patient's response to topical medication treatment is insufficient, or it is medically inappropriate to use topical medication for treatment
- The subjects and their partners agreed to take effective contraceptive measures from signing the Informed Consent Form (ICF) until 6 months after the end of treatment, and had no plans for childbirth, sperm donation or egg donation
Who cannot join
- The subject currently has a diagnosis of other active skin diseases (such as psoriasis or lupus erythematosus) that may affect the evaluation of AD
- Patients with eye diseases that the researchers judged as unsuitable for inclusion
- Patients with malignant tumors within 5 years
- There is evidence of active tuberculosis, or there has been evidence of active tuberculosis before and no appropriate documented treatment has been received
- Confirm active parasitic infection
- Those with active hepatitis, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb), or positive for hepatitis C virus (HCV) antibody, or positive for HIV antibody, or positive for (TP-Ab)
- Women who are breastfeeding or pregnant, or women planning to become pregnant or breastfeed during the study period
- Those who the researchers consider to have other circumstances that make them unsuitable to participate in the study
Trial locations and contacts
2 sites in 1 country.
China2 sites
Tower 5,No.34,Chunxiao Road No.122 Pudong District, Shanghai, 201203.p R. china
Shanghai, Shanghai Municipality, 201203
Hangzhou First People's Hospital
Zhejiang, 杭州, 310000
About this study
Official title: A Phase II Clinical Study on the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis
This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- MG-K10/Placebo
- 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/PlaceboDrug
To ensure blinding, 4 mL of placebo will be administered subcutaneously at Weeks 4, 12 and 20., for a total of 3 doses.
MG-K10/PlaceboDrug
To ensure blinding,an additional 2 mL of placebo will be administered subcutaneously at Weeks 4, 8, 12, 16 and 20.
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 Q8W | Active comparator | First dose MG-K10 600 mg (4 mL), followed by MG-K10 600 mg (4 mL) administered subcutaneously once every 8 weeks, for a total of 3 doses. Receives: Drug: MG-K10/Placebo |
| MG-K10 Q4W | Active comparator | First dose of MG-K10 600 mg (4 mL), followed by MG-K10 300 mg (2 mL) administered subcutaneously once every 4 weeks, for a total of 6 doses; Receives: Drug: MG-K10/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
Measured: 24 weeks
The percentage of subjects who achieved the IGA score standard at 24 weeks of treatment
The percentage of subjects whose IGA score reached 0 or 1 at 24 weeks of treatment (W24) and decreased by ≥2 points compared with the baseline;
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start30 Jun 2025
- Primary completion9 Mar 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
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
- NCT07103174
- Sponsor's protocol ID
- MG-K10-AD-005
- Acronym
- MG-K10
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study on the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07103174
- Acronym / sponsor ID
- MG-K10 / MG-K10-AD-005
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 5 Aug 2025 (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 study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.
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 Q8W | Active comparator | Drug: MG-K10/PlaceboFirst dose MG-K10 600 mg (4 mL), followed by MG-K10 600 mg (4 mL) administered subcutaneously once every 8 weeks, for a total of 3 doses. |
| MG-K10 Q4W | Active comparator | Drug: MG-K10/PlaceboFirst dose of MG-K10 600 mg (4 mL), followed by MG-K10 300 mg (2 mL) administered subcutaneously once every 4 weeks, for a total of 6 doses; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AD patients diagnosed in accordance with the consensus criteria of the American Academy of Dermatology (2014) had a history of AD or eczema diagnosis of ≥1 year
- The patient's response to topical medication treatment is insufficient, or it is medically inappropriate to use topical medication for treatment
- The subjects and their partners agreed to take effective contraceptive measures from signing the Informed Consent Form (ICF) until 6 months after the end of treatment, and had no plans for childbirth, sperm donation or egg donation
Key exclusion criteria (8 listed)
- The subject currently has a diagnosis of other active skin diseases (such as psoriasis or lupus erythematosus) that may affect the evaluation of AD
- Patients with eye diseases that the researchers judged as unsuitable for inclusion
- Patients with malignant tumors within 5 years
- There is evidence of active tuberculosis, or there has been evidence of active tuberculosis before and no appropriate documented treatment has been received
- Confirm active parasitic infection
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/PlaceboTo ensure blinding, 4 mL of placebo will be administered subcutaneously at Weeks 4, 12 and 20., for a total of 3 doses. | Drug | MG-K10 Q8W |
| MG-K10/PlaceboTo ensure blinding,an additional 2 mL of placebo will be administered subcutaneously at Weeks 4, 8, 12, 16 and 20. | Drug | MG-K10 Q4W |
Primary outcome
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
Time frame: 24 weeks
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
The percentage of subjects who achieved the IGA score standard at 24 weeks of treatment
Time frame: 24 weeks
The percentage of subjects whose IGA score reached 0 or 1 at 24 weeks of treatment (W24) and decreased by ≥2 points compared with the baseline;
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 3 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Atopic Dermatitis (AD), run by Shanghai Mabgeek Biotech.Co.Ltd at 2 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 3 inclusion and 8 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The percentage of subjects reaching EASI-75 at 24 weeks of treatment (time frame: 24 weeks). 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 3 Aug 2026.