Atopic DermatitisPhase 1/2NCT06765005
IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients
A Phase 1/2 study testing MG-K10 in people with Atopic Dermatitis, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial summary
This study was designed to reflect the safety pharmacokinetics and preliminary efficacy of MG-K10 Humanized Monoclonal Antibody Injection in adolescent patients 12-18 weeks of age with moderate to severe atopic dermatitis, administered every 2 or 4 weeks for 8 weeks Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- MG-K10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2024to Jul 2025
- Phase
- Phase 1/2
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12 years old ≤ <18 years old (based on the date of signing the ICF), regardless of gender.
- Body weight ≥ 30 kg;
- patients with a diagnosis of AD that meets the American Academy of Dermatology Consensus Criteria (2014), with a diagnosis of AD or history of eczema ≥6 months prior to screening, and with the following criteria
- 2. Patients with a diagnosis of AD that meets the American Academy of Dermatology Consensus Criteria (2014), a history of AD or eczema ≥ 6 months prior to screening, and the following criteria:
- EASI ≥16 at screening and baseline;
- EASI ≥16 at Screening and Baseline; IGA ≥3 at Screening and Baseline;
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- BSA involvement in skin lesions ≥10% at Screening and Baseline; 3. determined within 6 months prior to Screening to be inadequately treated with topical medications or medically inappropriate for treatment with topical medications; andmedically inappropriate for treatment with topical medications (e.g., significant side effects or safety risks).
- (e.g., significant side effects or safety risks);
- Inadequate efficacy is defined as:
- At least 4 weeks of potent or 2 weeks of ultra-potent topical glucocorticosteroids or 4 weeks of topical calcitonin within 6 months prior to Screening.Inadequate treatment outcome is defined as or maintain a state of remission or low disease activity (equivalent to an IGA score of 0 [=(equivalent to an IGA score of 0 [= asymptomatic] - 2 [= mildly symptomatic]);- Important side effects or safety risks are those that, as assessed by the investigator or the patient's treating physician, outweigh the potential therapeutic benefit.Important side effects or safety risks are those that, as assessed by the investigator or the patient's treating physician, outweigh the potential therapeutic benefit, including treatment intolerance Important side effect or safety risk means a side effect or risk that outweighs the potential therapeutic benefit, as assessed by the Investigator or the patient's treating physician, including treatment intolerance, allergic reaction, significant skin atrophy, and systemic reaction。 4. Subjects of potential reproductive potential (e.g., women who have had their first menstruation or men who have had spermatozoa) must agree to and comply with the use of effective contraception throughout the study period and for 6 months after the last dose.Subjects of potential reproductive potential (e.g., women who have had their first period or men who have had spermatozoa) must agree to and comply with effective contraception throughout the study period and for 6 months after the last dose.
- 5. the subject and/or the subject's parent or other legal guardian voluntarily signs a written informed consent form and is able to communicate with the investigator.
- Subjects and/or their parents or other legal guardians voluntarily sign a written informed consent form and are able to communicate well with the investigator and comply with protocol requirements for follow-up visits.
Who cannot join
- Individuals with severe allergic reactions to the test drug or its analogs; those who cannot administer subcutaneous injections, e.g., those on anticoagulant therapy, known bleeding disorders, or idiopathic thrombocytopenic purpura;
- Presence of other active skin conditions (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation;
- Presence of diseases that may require systemic hormonal or immunosuppressive therapy;
- Patients with ocular disease that, in the judgment of the investigator, is not appropriate for enrollment, such as a previous history of atopic keratoconjunctivitis with involvement of the cornea; an ophthalmologist will be required to make a diagnosis if the investigator is unable to make a determination;
- Use of targeted inhibitors (e.g., JAK inhibitors), systemic glucocorticoids, cyclosporine, or other immunosuppressants (e.g., methotrexate) within 4 weeks prior to randomization systemic glucocorticoids, cyclosporine or other immunosuppressive agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, ultraviolet (UV) radiation, and other immunosuppressive agents.
- Systemic glucocorticoids, cyclosporine or other immunosuppressants (e.g., methotrexate, mycophenolate mofetil, and azathioprine), phosphodiesterase (PDE4) inhibitors, ultraviolet radiation therapy, systemic AD Cyclosporine or other immunosuppressants (methotrexate, mycophenolate mofetil, and azathioprine), phospholipase (PDE4) inhibitors, ultraviolet radiation therapy, and systemic herbal medicine for AD Have used a biologic within 10 weeks prior to randomization or have not exceeded 5 half-lives (whichever is longer).
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- have used a biologic agent within 10 weeks prior to randomization or have not exceeded 5 half-lives, whichever is longer;)
- -Allergen-specific immunotherapy in the 6 months prior to randomization;
- Those who stopped all topical medications for less than 2 weeks prior to randomization, including topical glucocorticoids, topical calcium-modulated phosphatase inhibitors, antibiotic-complexed creams, and topical herbal treatments;
- Participated in a clinical study with a biologic within 3 months or 5 half-lives, whichever is longer, prior to screening; participated in a clinical study with a biologic within 1 month or 5 half-lives, whichever is longer, prior to randomization.
- Participated in a clinical study with a biologic agent within 3 months or 5 half-lives, whichever is longer, prior to screening; participated in a clinical study with a non-biologic agent within 1 month or 5 half-lives, whichever is longer, prior to randomization.
- Participated in a clinical study of a non-biologic agent drug within 1 month or 5 half-lives, whichever is longer, prior to randomization, or plans to participate in a clinical study of another drug during the study period.
- Participated in a clinical study of a non-biologic agent drug within 1 month or 5 half-lives, whichever is longer, prior to randomization, or plan to participate in a clinical study of another drug during the study period.
- Subjects who have participated in a clinical study of this product; subjects who have used monoclonal antibodies to the interleukin 4 receptor alpha subunit (IL-4Rα) and, in the judgment of the investigator, have developed resistance or serious drug-related AEs.
- Subjects who, in the judgment of the Investigator, have developed drug resistance or severe drug-related AEs;
- Those who have received live/live attenuated vaccine within 3 months prior to screening or plan to do so during the study;
- Persons with chronic active infections or acute infections requiring systemic (oral and intravenous) antipathogenic microbial (anti-bacterial, viral, fungal, etc.) therapy within 4 weeks prior to randomization;
- Evidence of active tuberculosis or previous evidence of active tuberculosis without appropriate documented treatment; active tuberculosis infection as indicated by chest X-ray (frontal and lateral) or CT, etc., within 3 months prior to/screening period;
- History of parasitic infection within 6 months prior to screening;
- Patients with a history of malignant tumors;
- Comorbidities of other serious diseases, including but not limited to cardiovascular, metabolic, and neurological diseases, which are assessed by the investigator to be unsuitable for immunosuppressive therapy;
- Those who, in the opinion of the investigator, have other conditions that make them unsuitable for participation in the study;
- History of alcohol or drug abuse within 6 months prior to screening;
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, 1 recruiting
- Recruiting
Hangzhou First People's Hospital;
Hangzhou, Zhejiang, 310000
liming Wu, Medical
About this study
Official title: A Phase Ib/II.a Clinical Study of the Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10Humanized Monoclonal Antibody Injection in Adolescent Patients with Moderate to Severe Atopic Dermatitis Aged 12-18 Years.
This study was designed to reflect the safety pharmacokinetics and preliminary efficacy of MG-K10 Humanized Monoclonal Antibody Injection in adolescent patients 12-18 weeks of age with moderate to severe atopic dermatitis, administered every 2 or 4 weeks for 8 weeks
Read the detailed description
Primary Objective:
To evaluate the MG-K10 humanized monoclonal antibody injection in adolescent moderate-to-severe atopic dermatitis (AD) patients.
Secondary Objective:
To evaluate the pharmacokinetic (PK) profile, preliminary efficacy, and safety of MG-K10 humanized monoclonal antibody injection in adolescent patients with moderate-to-severe AD.To assess the pharmacokinetic (PK) profile, preliminary efficacy, pharmacokinetic (PD) profileand immunogenicity.
- Conditions
- Atopic Dermatitis
- Being tested
- MG-K10
- Keywords
- Atopic Dermatitis
- 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-K10Drug
Subcutaneous injection, once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 Regimen 1 | Experimental | Subcutaneous injection, once every 2 weeks Receives: Drug: MG-K10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
security
Measured: up to 113 days
Secondary outcomes (11)
PK finish line
PK endpoint: MG-K10 blood concentration
Measured: up to 113 days
PK finish line
Cmax
Measured: up to 147 days
PK finish line
AUC
Measured: 21week
Percentage of subjects with an overall investigator-assessed IGA score
Percentage of subjects with an overall investigator-assessed IGA score of 0 or 1 from baseline at each evaluation visit site;
Measured: 8 weeks after administration
Percentage of subjects with an overall investigator-assessed IGA score decrease of ≥2 points from baseline at each evaluation visit site;
Effectiveness
Measured: 8 weeks after administration
The changes in eczema area at each evaluation visit point compared with the baseline.
Change from baseline and rate of change in eczema area and severity index (EASI) score at each evaluation visit site;
Measured: up to 113 days
Percentage of subjects achieving EASI-50, EASI-75, and EASI-90 at each evaluation visit site;
Percentage of subjects achieving EASI-50, EASI-75, and EASI-90 (≥ 50% / 75% / 90% reduction in EASI score from baseline) at each evaluation visit viewpoint;
Measured: up to 113 days
Change from baseline in weekly mean NRS
Change from baseline and rate of change in weekly mean of daily peak itch score（Numerical rating scale 0-10）;
Measured: up to 113 days
Change from baseline in weekly mean NRS score
Percentage of subjects whose weekly mean daily peak itch score （Numerical rating scale 0-10）decreased by ≥4 points from baseline;
Measured: up to 113 day
Change in BSA from baseline
Change from baseline and rate of change in body surface area (BSA) involved in skin lesions at each evaluation visit site;
Measured: up to 113 days
(POEM) score change from baseline
Change from baseline in patient eczema self-assessment (POEM) scores at each evaluation visit site;
Measured: up to 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start19 Jul 2024
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Drug dosage: 600mg for the first time, 300mg for the next time, subcutaneous injection, divided into 2 groups, every 2 weeks for a total of 4 doses, every 4 weeks for a total of 2 doses
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- liming wu, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765005
- Sponsor's protocol ID
- MG-K10-AD-004
- Status last verified
- Dec 2024
- First submitted
- 12 Jul 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We may work with other companies to develop follow-up clinical programs in China or global clinical programs
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II.a Clinical Study of the Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10Humanized Monoclonal Antibody Injection in Adolescent Patients with Moderate to Severe Atopic Dermatitis Aged 12-18 Years.
- ClinicalTrials.gov ID
- NCT06765005
- Acronym / sponsor ID
- MG-K10-AD-004
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Jan 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 was designed to reflect the safety pharmacokinetics and preliminary efficacy of MG-K10 Humanized Monoclonal Antibody Injection in adolescent patients 12-18 weeks of age with moderate to severe atopic dermatitis, administered every 2 or 4 weeks for 8 weeks
Detailed description
Primary Objective:
To evaluate the MG-K10 humanized monoclonal antibody injection in adolescent moderate-to-severe atopic dermatitis (AD) patients.
Secondary Objective:
To evaluate the pharmacokinetic (PK) profile, preliminary efficacy, and safety of MG-K10 humanized monoclonal antibody injection in adolescent patients with moderate-to-severe AD.To assess the pharmacokinetic (PK) profile, preliminary efficacy, pharmacokinetic (PD) profileand immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Drug dosage: 600mg for the first time, 300mg for the next time, subcutaneous injection, divided into 2 groups, every 2 weeks for a total of 4 doses, every 4 weeks for a total of 2 doses
| Arm | Type | Receives |
|---|---|---|
| MG-K10 Regimen 1 | Experimental | Drug: MG-K10Subcutaneous injection, once every 2 weeks |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 12 years old ≤ <18 years old (based on the date of signing the ICF), regardless of gender.
- Body weight ≥ 30 kg;
- patients with a diagnosis of AD that meets the American Academy of Dermatology Consensus Criteria (2014), with a diagnosis of AD or history of eczema ≥6 months prior to screening, and with the following criteria
- 2. Patients with a diagnosis of AD that meets the American Academy of Dermatology Consensus Criteria (2014), a history of AD or eczema ≥ 6 months prior to screening, and the following criteria:
- EASI ≥16 at screening and baseline;
Key exclusion criteria (23 listed)
- Individuals with severe allergic reactions to the test drug or its analogs; those who cannot administer subcutaneous injections, e.g., those on anticoagulant therapy, known bleeding disorders, or idiopathic thrombocytopenic purpura;
- Presence of other active skin conditions (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation;
- Presence of diseases that may require systemic hormonal or immunosuppressive therapy;
- Patients with ocular disease that, in the judgment of the investigator, is not appropriate for enrollment, such as a previous history of atopic keratoconjunctivitis with involvement of the cornea; an ophthalmologist will be required to make a diagnosis if the investigator is unable to make a determination;
- Use of targeted inhibitors (e.g., JAK inhibitors), systemic glucocorticoids, cyclosporine, or other immunosuppressants (e.g., methotrexate) within 4 weeks prior to randomization systemic glucocorticoids, cyclosporine or other immunosuppressive agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, ultraviolet (UV) radiation, and other immunosuppressive agents.
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-K10Subcutaneous injection, once every 4 weeks | Drug | MG-K10 Regimen 1 |
Primary outcome
Incidence and severity of adverse events
Time frame: up to 113 days
security
11 secondary outcomes
PK finish line
Time frame: up to 113 days
PK finish line
Time frame: up to 147 days
PK finish line
Time frame: 21week
Percentage of subjects with an overall investigator-assessed IGA score
Time frame: 8 weeks after administration
Percentage of subjects with an overall investigator-assessed IGA score decrease of ≥2 points from baseline at each evaluation visit site;
Time frame: 8 weeks after administration
The changes in eczema area at each evaluation visit point compared with the baseline.
Time frame: up to 113 days
Percentage of subjects achieving EASI-50, EASI-75, and EASI-90 at each evaluation visit site;
Time frame: up to 113 days
Change from baseline in weekly mean NRS
Time frame: up to 113 days
Change from baseline in weekly mean NRS score
Time frame: up to 113 day
Change in BSA from baseline
Time frame: up to 113 days
(POEM) score change from baseline
Time frame: up to 113 days
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 9 Jan 2025.
- Individual participant dataSharing planned: No. We may work with other companies to develop follow-up clinical programs in China or global clinical programs
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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.
liming wu principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MG-K10 in people with Atopic Dermatitis, 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 12 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 xiaofeng Cai (02151371305, xiaofeng.cai@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: up to 113 days). 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 9 Jan 2025.