A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Mabgeek Biotech.Co.Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MG-K10 placebo

Treatment groups

60 Participants
are divided into 2 treatment groups