Placebo: Every four weeks, subcutaneous injection,Switch to MG-K10 treatment after 24 weeks of administration
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Proportions of subjects achieving WI-NRS — week 24 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
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital, Beijing,
Beijing
Bejing
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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