RecruitingPhase 3NCT06779136
Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis
A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of a Humanized MG-K10 Mab Injection in Subjects With Prurigo Nodularis.
Sponsor
Shanghai Mabgeek Biotech.Co.Ltd
Enrollment
160 participants
Start Date
Feb 26, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria5
- 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 Criteria4
- 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
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Interventions
DRUGPlacebo
Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06779136
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