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Recruiting Phase 3

Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis

NCT06779136 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-02-26
Last updated
2025-04-18

Condition(s) studied

Prurigo Nodularis

Investigational drug(s) / intervention(s)

Placebo

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)

FacilityCityRegionStatus
Peking University People's Hospital, Beijing, Beijing Bejing Recruiting
Official registry record

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.

View NCT06779136 on ClinicalTrials.gov ↗ ← All trials in China