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

NCT06779136 | Recruiting Phase 3

• 1 other identifier: MG-K10-PN-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Prurigo Nodularis

Keywords

Prurigo nodularis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Proportions of subjects achieving IGA PN-S score of 0/1 point

  week 24

• 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;

  From baseline to week 56

• Duration of onset of response to pruritus

  From baseline to week 56

• the first response to pruritus occurred.

  from baseline to the week 24

Study Arms (2)

MG-K10 Humanized Monoclonal Antibody Injection

EXPERIMENTAL

Every four weeks, subcutaneous injection ，total of 56W

Drug: Placebo

placebo

PLACEBO COMPARATOR

Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration

Drug: Placebo

Interventions

Placebo DRUG

Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration

MG-K10 Humanized Monoclonal Antibody Injection; placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• There are skin diseases other than PN and mild atopic dermatitis (AD) that may interfere with the assessment of research outcomes.
• Patients who had a history of moderate to severe AD during the 6 months prior to the screening visit or screening visit.
• Receiving potent or super-potent TCS/TCI treatment within 2 weeks before or during screening.
• \) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (1)

Peking University People's Hospital, Beijing,

Beijing, Bejing, 100009, China

RECRUITING

Study Officials

• Jianzhong Zhang, Medical Ph.D

  Feking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

xiaofeng xiao Cai, bachelor

CONTACT

02151371305; xiaofeng.cai@mabgeek.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 16, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)