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About
This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.
Full description
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It is planned to enroll approximately 160 adult patients with moderate-to-severe AD uncontrolled by topical therapy, who will receive multiple subcutaneous injections. The study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
key Inclusion Criteria:
Aged 18 - 70 years (inclusive), male or female;
Patients diagnosed with AD according to American Academy of Dermatology Consensus Criteria (2014) for at least 6 months prior to screening and meet the following criteria:
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
163 participants in 4 patient groups, including a placebo group
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Central trial contact
xiaofeng Cai, bachelor
Data sourced from clinicaltrials.gov
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