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RECRUITINGPHASE3

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.

NCT06779136•Shanghai Mabgeek Biotech.Co.Ltd

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Locations (1)

Peking University People's Hospital, Beijing,

Beijing, Bejing, China

Key Dates

Start Date

February 26, 2025

Primary Completion Date

August 1, 2026

Completion Date

November 1, 2026

Last Updated

April 18, 2025

Enrollment

160

ESTIMATED participants

Conditions

Prurigo Nodularis

Interventions

Placebo

DRUG

Contacts

xiaofeng xiao Cai, bachelor

CONTACT

02151371305 xiaofeng.cai@mabgeek.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

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