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.
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.
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.
Parallel
Placebo
DrugEvery four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
Proportions of subjects achieving WI-NRS
In the experimental group, the weekly mean value of WI-NRS at week 24 was compared with baseline.Proportion of subjects who improved (decreased) by ≥ 4 points
Proportions of subjects achieving IGA PN-S score of 0/1 point
Proportion of subjects with overall disease score of 0/1
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
Duration of onset of response to pruritus
The proportion of subjects with a weekly mean decrease of ≥4 points from baseline in the WI-NRS was compared, and the difference from the placebo group was first presented p \< 0.05).
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