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
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
Treatments tested in this trial
- MG-K10
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov