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

Last updated: April 15, 2025
Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Prurigo Nodularis

Atopic Dermatitis

Eczema (Atopic Dermatitis - Pediatric)

Treatment

Placebo

Clinical Study ID

NCT06779136
MG-K10-PN-001
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

  1. Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 26, 2025
Estimated Completion Date:
November 30, 2026

Study 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).

Connect with a study center

  • Peking University People's Hospital, Beijing,

    Beijing, bejing 100009
    China

    Active - Recruiting

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