Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis
Trial Parameters
Brief Summary
A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.administered every 4 weeks for 56 weeks.
Eligibility Criteria
eligibility criteria: 1. voluntarily sign the ICF and comply with all the visits and research-related procedures required by the protocol; 2. Both men and women were required to be ≥ 18 and ≤ 80 years old at the time of signing the informed consent; 3. the duration of PN diagnosed by a dermatologist at the time of screening was ≥ 3 months; 4. In the range of 1-10, WI-NRS≥7 in the past 24 h at screening; WI-NRS in the week before the baseline visit The average weekly score was ≥ 7 points. Exclusion criteria： 1. There are skin diseases other than PN and mild atopic dermatitis (AD) that may interfere with the assessment of research outcomes. 2. Patients who had a history of moderate to severe AD during the 6 months prior to the screening visit or screening visit. 3. Receiving potent or super-potent TCS/TCI treatment within 2 weeks before or during screening. 4\) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening