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

Phase 3RecruitingNCT06779136

Shanghai Mabgeek Biotech.Co.Ltd160 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Prurigo Nodularis

Interventions

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: week 24

Secondary Outcomes

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

Proportion of subjects with overall disease score of 0/1

Time frame: week 24

The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit

Time frame: From baseline to week 56

The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;

Time frame: 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).

Time frame: 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)

Time frame: from baseline to the week 24

The time when the first intergroup response difference in pruritus occurred

Central Contacts

xiaofeng xiao Cai, bachelor

CONTACT

02151371305 xiaofeng.cai@mabgeek.com

Data from ClinicalTrials.gov

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