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

Phase 3

Recruiting

• Conditions: Prurigo Nodularis
• Interventions: Drug: Placebo

• Registration Number: NCT06779136
• Lead Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

Brief 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).

Study Timeline

• Study First Submitted: 2024-12-30
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-12
• Study First Posted: 2025-01-16
• Study Start: 2025-02-26
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-08
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MG-K10 Humanized Monoclonal Antibody Injection	Placebo	Every four weeks, subcutaneous injection ，total of 56W
placebo	Placebo	Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Proportions of subjects achieving IGA PN-S score of 0/1 point	week 24	Proportion of subjects with overall disease score of 0/1
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit	From baseline to week 56	The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit
The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;	From baseline to week 56	The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;
Duration of onset of response to pruritus	From baseline to week 56	The proportion of subjects with a weekly mean decrease of ≥4 points from baseline in the WI-NRS was compared, and the difference from the placebo group was first presented p \< 0.05).
the first response to pruritus occurred.	from baseline to the week 24	The time from baseline to the 24th week when the first response to pruritus occurred (the average weekly WI-NRS score decreased by ≥ 4 points compared with the baseline)
The time when the first intergroup response difference in pruritus occurred	From baseline to week 24	The time of the first intergroup response difference for pruritus (the time when the difference in the proportion of subjects with a weekly average WI-NRS score reduction of ≥ 4 points compared to the baseline first reached p \< 0.05 compared with the placebo group)
The duration of the difference in persistent response to pruritus between groups	From baseline to week 24	The duration of the difference in persistent response between the prurity-onset groups (comparing the change in weekly WI-NRS from baseline between the MG-K10 and placebo groups, the time when the difference between the MG-K10 and placebo groups first appeared to be p \< 0.05 and remained significant on subsequent measures)
Proportion of subjects with an IGA PN-S score of 0/1	From baseline to week 56	Proportion of subjects with IGA PN-S score of 0/1 at each evaluation visit
Changes in IGA PN-S scores	From baseline to week 56	Changes in IGA PN-S scores from baseline at each evaluation site
Proportion of subjects with an IGA PN-A score of 0/1	From baseline to week 56	Proportion of subjects with an IGA PN-A score of 0/1 from baseline to each visit point
Changes in IGA PN-A scores from baseline	From baseline to week 56	Changes in IGA PN-A scores from baseline at each evaluation visit
Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1	From baseline to week 56	Proportion of subjects with weekly WI-NRS improvement (decrease) of ≥ 4 points from baseline and IGA PN-S of 0/1 at each evaluation visit
Changes in DLQI scores from baseline	From baseline to week 56	Change in Dermatology Life Quality Index (DLQI) from baseline at each evaluation visit
Changes in HADS from baseline	From baseline to week 56	Changes in Hospital Anxiety and Depression Scale(HADS) from baseline at each evaluation site
safety	From baseline to week 56	These include Treatment Emergent Adverse Events (TEAE) and Serious Adverse events Events (SAE), adverse events of special interest (AESI), clinical laboratory tests, vital signs, physical examination, and abnormalities in 12-lead electrocardiograms;
pharmacokinetics	From baseline to week 56	Ctrough (valley concentration) change over time;
pharmacodynamics	From baseline to week 56	Changes of biomarkers before and after administration
immunogenicity	From baseline to week 56	Occurrence of Anit-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb)

Trial Locations

Locations (1)

Peking University People's Hospital, Beijing,; 🇨🇳 Beijing, bejing, China