Atopic DermatitisPhase 3NCT06026891
Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis
A Phase 3 study of Atopic Dermatitis, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial summary
The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.administered every 4 weeks for 52 week Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2024to 12 Dec 2025
- Phase
- Phase 3
- 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
- age 18-75 years (inclusive of 18 and 75 years), both sexes;
- patients with AD diagnosed in accordance with the American Academy of Dermatology Consensus Criteria (2014), with a pre-screening diagnosis of AD or history of eczema for ≥1 year, and the following:
- Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visit;
- Investigator's Overall Assessment (IGA) ≥3 points at screening and baseline visit;
- BSA ≥10% of area of AD involvement at screening and baseline visit
- Weekly mean of peak daily itch NRS score ≥4 at randomization;
- the patient had an inadequate treatment effect on topical medication or systemic therapy within 6 months prior to the screening visit, or the use of topical medication or systemic therapy was medically inappropriate
- negative screening blood pregnancy test results in women of childbearing age;
Who cannot join
- subjects with a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) that may interfere with AD evaluation;
- Patients with ocular disease that, in the judgment of the Investigator, makes enrollment in the study inappropriate, e.g., past history of atopic keratoconjunctivitis with corneal involvement; if the Investigator is unable to make a determination, a diagnosis will be made by an ophthalmologist;
- those who plan to undergo major surgery during the study period, including inpatient surgery and daytime outpatient surgery;
- Subjects with the following conditions:
- Persons who have used a biologic agent within 10 weeks prior to randomization or have not exceeded 5 half-lives (whichever is longer); Targeted inhibitors (e.g., JAK inhibitors, etc.), systemic glucocorticoids, cyclosporine and other immunosuppressants (e.g., methotrexate, mycophenolate mofetil [MMF], and azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, ultraviolet light therapy, and systemic herbal medicine for AD within 4 weeks prior to randomization;
- Has received topical glucocorticosteroids, topical calcineurin phosphatase inhibitors, antibiotic compound cream, and topical herbal therapy for AD within 1 week before randomization;
Show all 13Show fewer
- Has received allergen-specific immunotherapy within 6 months prior to randomization;
- Live/live attenuated vaccination within 3 months prior to randomization or planned for the duration of the study;
- Participation in a clinical study of another drug in the 3 months or 5 half-lives, whichever is longer, prior to randomization or planning to participate in a clinical study of another drug during the study period;
- Subjects with prior use of an interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody drug who, in the judgment of the investigator, have developed drug resistance or drug-related serious AE;
- Previous participation in the MG-K10 clinical trial;
- evidence of active tuberculosis, or previous evidence of active tuberculosis without appropriate documented treatment; chest X-ray (frontal and lateral) or CT, etc. within 3 months prior to/surrounding the screening period suggesting the presence of active tuberculosis infection;
- women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeed during the study;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Jianzhong Zhang, Medical Ph.D
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Effectiveness and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis
The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.administered every 4 weeks for 52 week
Read the detailed description
The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 498 adults with moderate-to-severe AD who were not controlled by local therapy were scheduled to receive multiple subcutaneous injections (administered every 4 weeks for 52 weeks). The study was divided into screening period (1-5 weeks), double-blind treatment period (16 weeks), treatment maintenance period (36 weeks), and follow-up period (8 weeks).
- Conditions
- Atopic Dermatitis
- Being tested
- MG-K10/Placebo
- 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-K10/PlaceboDrug
MG-K10 Humanized Monoclonal Antibody Injection
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Every four weeks, subcutaneous injection ，total of 52W Receives: Drug: MG-K10/Placebo |
| MG-K10 placebo | Placebo comparator | Every four weeks, subcutaneous injection，The drug was transferred to the trial after 16 weeks Receives: Drug: MG-K10/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of subjects achieving EASI-75
Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI
Measured: 16 weeks
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
Measured: 16weeks
Secondary outcomes (11)
The percentage of subjects who reached EASI-75 at other evaluation points;
The percentage of subjects who reached EASI-75 at other evaluation points;
Measured: 16 weeks
Other evaluation points of view subjects with an IGA score of 0 or 1
Other evaluation points of view subjects with an IGA score of 0 or 1 and a decrease of ≥ 2 points from the baseline
Measured: 16 weeks
Percentage of subjects who reach EASI-50
Percentage of subjects who reach EASI-50 (EASI score is ≥50% lower than the baseline)
Measured: 16 weeks
Percentage of subjects who reach EASI-90
Percentage of subjects who reach EASI-90 (EASI score is ≥90% lower than the baseline)
Measured: 16 weeks
Each evaluation point of view EASI
Each evaluation point of view EASI score compared with the baseline change and change rate
Measured: 16 weeks
Percentage of subjects with a decrease of ≥2
Percentage of subjects with a decrease of ≥2 points from the baseline IGA score at each evaluation point of view
Measured: 16 weeks
Percentage of subjects with a weekly average of daily peak itching NRS score ≥3
Percentage of subjects with a weekly average of daily peak itching NRS score ≥3 points lower than the baseline;
Measured: 16 weeks
The AD of each evaluation visit involves the change and rate of the baseline of BSA;
The AD of each evaluation visit involves the change and rate of the baseline of BSA;
Measured: 16 weeks
The DLQI score of each evaluation interview has changed compared with the baseline.
The DLQI score of each evaluation interview has changed compared with the baseline.
Measured: 16 weeks
The self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;
The self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;
Measured: 16 weeks
The European Five-dimensional Health Scale (EQ-5D)
The European Five-dimensional Health Scale (EQ-5D) at each evaluation point of view is more than the baseline change and rate of change.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start13 Jan 2024
- Primary completion11 Jun 2025 (estimated)
- Study completion12 Dec 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effectiveness of MG-K10 humanized monoclonal antibody injection in patients with moderate and severe atopic dermatitis Randomized, double-blind, placebo-controlled phase III clinical study with safety
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Medical Ph.D, Principal investigator, Feking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026891
- Sponsor's protocol ID
- MG-K10-AD-003
- Status last verified
- Dec 2023
- First submitted
- 31 Aug 2023
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Effectiveness and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06026891
- Acronym / sponsor ID
- MG-K10-AD-003
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 11 Jun 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 7 Sep 2023 (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.
The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.administered every 4 weeks for 52 week
Detailed description
The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 498 adults with moderate-to-severe AD who were not controlled by local therapy were scheduled to receive multiple subcutaneous injections (administered every 4 weeks for 52 weeks). The study was divided into screening period (1-5 weeks), double-blind treatment period (16 weeks), treatment maintenance period (36 weeks), and follow-up period (8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Effectiveness of MG-K10 humanized monoclonal antibody injection in patients with moderate and severe atopic dermatitis Randomized, double-blind, placebo-controlled phase III clinical study with safety
| Arm | Type | Receives |
|---|---|---|
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Drug: MG-K10/PlaceboEvery four weeks, subcutaneous injection ，total of 52W |
| MG-K10 placebo | Placebo comparator | Drug: MG-K10/PlaceboEvery four weeks, subcutaneous injection，The drug was transferred to the trial after 16 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 18-75 years (inclusive of 18 and 75 years), both sexes;
- patients with AD diagnosed in accordance with the American Academy of Dermatology Consensus Criteria (2014), with a pre-screening diagnosis of AD or history of eczema for ≥1 year, and the following:
- the patient had an inadequate treatment effect on topical medication or systemic therapy within 6 months prior to the screening visit, or the use of topical medication or systemic therapy was medically inappropriate
- negative screening blood pregnancy test results in women of childbearing age;
Key exclusion criteria (13 listed)
- subjects with a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) that may interfere with AD evaluation;
- Patients with ocular disease that, in the judgment of the Investigator, makes enrollment in the study inappropriate, e.g., past history of atopic keratoconjunctivitis with corneal involvement; if the Investigator is unable to make a determination, a diagnosis will be made by an ophthalmologist;
- those who plan to undergo major surgery during the study period, including inpatient surgery and daytime outpatient surgery;
- Subjects with the following conditions:
- evidence of active tuberculosis, or previous evidence of active tuberculosis without appropriate documented treatment; chest X-ray (frontal and lateral) or CT, etc. within 3 months prior to/surrounding the screening period suggesting the presence of active tuberculosis 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/PlaceboMG-K10 Humanized Monoclonal Antibody Injection | Drug | MG-K10 Humanized Monoclonal Antibody Injection, MG-K10 placebo |
Primary outcome
Proportions of subjects achieving EASI-75
Time frame: 16 weeks
Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2
Time frame: 16weeks
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
11 secondary outcomes
The percentage of subjects who reached EASI-75 at other evaluation points;
Time frame: 16 weeks
Other evaluation points of view subjects with an IGA score of 0 or 1
Time frame: 16 weeks
Percentage of subjects who reach EASI-50
Time frame: 16 weeks
Percentage of subjects who reach EASI-90
Time frame: 16 weeks
Each evaluation point of view EASI
Time frame: 16 weeks
Percentage of subjects with a decrease of ≥2
Time frame: 16 weeks
Percentage of subjects with a weekly average of daily peak itching NRS score ≥3
Time frame: 16 weeks
The AD of each evaluation visit involves the change and rate of the baseline of BSA;
Time frame: 16 weeks
The DLQI score of each evaluation interview has changed compared with the baseline.
Time frame: 16 weeks
The self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;
Time frame: 16 weeks
The European Five-dimensional Health Scale (EQ-5D)
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
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. This study is not recruiting at the moment.
Jianzhong Zhang, Medical Ph.D principal investigator
Feking University People's Hospital
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 of 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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaofeng Cai, bachelor (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?
Proportions of subjects achieving EASI-75 (time frame: 16 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 23 Feb 2024.