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IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients

ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorShanghai Mabgeek Biotech.Co.Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

12 years old ≤ <18 years old (based on the date of signing the ICF), regardless of gender.

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

EASI ≥16 at screening and baseline;

EASI ≥16 at Screening and Baseline; IGA ≥3 at Screening and Baseline;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • MG-K10

    Drug

    Subcutaneous injection, once every 4 weeks

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: MG-K10 Regimen 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events

security

Time frame
up to 113 days

Secondary outcomes

1

PK finish line

PK endpoint: MG-K10 blood concentration

Time frame
up to 113 days
2

PK finish line

Cmax

Time frame
up to 147 days
3

PK finish line

AUC

Time frame
21week
4

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;

Time frame
8 weeks after administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Mabgeek Biotech.Co.Ltd

Lead sponsor

Source ClinicalTrials.gov
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