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.

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.

Study Overview

• Status: Recruiting
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: xiaofeng xiao Cai, bachelor; Phone Number: 02151371305; Email: xiaofeng.cai@mabgeek.com

Study Locations

• China
  • bejing
    • Beijing, bejing, China, 100009
      • Recruiting
      • Peking University People's Hospital, Beijing,
      • Contact: Jianzhong Zhang, Medical Ph.D; Phone Number: 010-88326666; Email: rmzjz@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MG-K10 Humanized Monoclonal Antibody Injection; Every four weeks, subcutaneous injection ，total of 56W	Drug: Placebo; Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
Placebo Comparator: placebo; Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration	Drug: Placebo; Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportions of subjects achieving WI-NRS	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	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportions of subjects achieving IGA PN-S score of 0/1 point	Proportion of subjects with overall disease score of 0/1	week 24
The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit	The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 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;	The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;	From baseline to week 56
Duration of onset of response to pruritus	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).	From baseline to week 56
the first response to pruritus occurred.	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)	from baseline to the week 24
The time when the first intergroup response difference in pruritus occurred	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)	From baseline to week 24
The duration of the difference in persistent response to pruritus between groups	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)	From baseline to week 24
Proportion of subjects with an IGA PN-S score of 0/1	Proportion of subjects with IGA PN-S score of 0/1 at each evaluation visit	From baseline to week 56
Changes in IGA PN-S scores	Changes in IGA PN-S scores from baseline at each evaluation site	From baseline to week 56
Proportion of subjects with an IGA PN-A score of 0/1	Proportion of subjects with an IGA PN-A score of 0/1 from baseline to each visit point	From baseline to week 56
Changes in IGA PN-A scores from baseline	Changes in IGA PN-A scores from baseline at each evaluation visit	From baseline to week 56
Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1	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	From baseline to week 56
Changes in DLQI scores from baseline	Change in Dermatology Life Quality Index (DLQI) from baseline at each evaluation visit	From baseline to week 56
Changes in HADS from baseline	Changes in Hospital Anxiety and Depression Scale(HADS) from baseline at each evaluation site	From baseline to week 56
safety	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;	From baseline to week 56
pharmacokinetics	Ctrough (valley concentration) change over time;	From baseline to week 56
pharmacodynamics	Changes of biomarkers before and after administration	From baseline to week 56
immunogenicity	Occurrence of Anit-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb)	From baseline to week 56

Collaborators and Investigators

• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
• Investigators: Study Director: Jianzhong Zhang, Medical Ph.D, Feking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Prurigo nodularis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Prurigo; Neurodermatitis
• Other Study ID Numbers: MG-K10-PN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No