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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-26

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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

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Prurigo Nodularis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MG-K10 Humanized Monoclonal Antibody Injection

Every four weeks, subcutaneous injection ，total of 56W

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No