NCT06779136

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 160 adults with prurigo nodularis were scheduled to receive multiple subcutaneous injections (every 4 weeks for 56 weeks). The study was divided into a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a maintenance treatment period (24 weeks), and a follow-up period (8 weeks).

Conditions

• Prurigo Nodularis

Interventions

Type	Name	Description
DRUG	Placebo	Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration

Timeline

• Start date: 2025-02-26
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-01-16
• Last updated: 2025-04-18

Locations

1 site across 1 country: China