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.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
⁃ 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.
Locations
Other Locations
China
Peking University People's Hospital, Beijing,
RECRUITING
Beijing
Contact Information
Primary
xiaofeng xiao Cai, bachelor
xiaofeng.cai@mabgeek.com
02151371305
Time Frame
Start Date: 2025-02-26
Estimated Completion Date: 2026-11
Participants
Target number of participants: 160
Treatments
Experimental: MG-K10 Humanized Monoclonal Antibody Injection
Every four weeks, subcutaneous injection ，total of 56W
Placebo_comparator: placebo
Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
Related Therapeutic Areas
Sponsors
Leads: Shanghai Mabgeek Biotech.Co.Ltd