Overview
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.
Description
The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 160 adults with prurigo nodularis were scheduled to receive multiple subcutaneous injections (every 4 weeks for 56 weeks). The study was divided into a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a maintenance treatment period (24 weeks), and a follow-up period (8 weeks).
Eligibility
eligibility criteria:
- voluntarily sign the ICF and comply with all the visits and research-related procedures required by the protocol;
- Both men and women were required to be ≥ 18 and ≤ 80 years old at the time of signing the informed consent;
- the duration of PN diagnosed by a dermatologist at the time of screening was ≥ 3 months;
- 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：
- There are skin diseases other than PN and mild atopic dermatitis (AD) that may interfere with the assessment of research outcomes.
- Patients who had a history of moderate to severe AD during the 6 months prior to the screening visit or screening visit.
- Receiving potent or super-potent TCS/TCI treatment within 2 weeks before or during screening.
- Evidence of active tuberculosis. 5) Participation in any other clinical study within
12 weeks or 5 half-lives prior to screening