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

Launched by SHANGHAI MABGEEK BIOTECH.CO.LTD · Jan 12, 2025

Keywords

ClinConnect Summary

This clinical trial, called a Phase III study, is evaluating the effectiveness and safety of a new medication called MG-K10 for people with prurigo nodularis, a skin condition that causes itchy bumps. The trial will last for 56 weeks, and participants will receive the MG-K10 injection every four weeks. The study is currently looking for volunteers aged between 18 and 80 who have been diagnosed with prurigo nodularis for at least three months and have been experiencing significant itching.

To be eligible, participants need to agree to follow the study procedures and attend all necessary visits. They should also be experiencing severe itching, with scores indicating high levels of discomfort. However, individuals with other skin diseases that could affect the trial results, those who have had certain skin conditions recently, or anyone currently taking specific medications may not qualify. If you or someone you know is interested in participating, this trial presents an opportunity to potentially help improve treatment options for prurigo nodularis while closely monitored by healthcare professionals.

Gender

ALL

Eligibility criteria

• 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