Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06779136

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prurigo Nodularis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital, Beijing,

Beijing, Bejing, 100009, China

Location status: Recruiting

Location contact

Jianzhong Zhang, Medical Ph.D

CONTACT

[email protected]

010-88326666

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

eligibility criteria:

  • voluntarily sign the ICF and comply with all the visits and research-related procedures required by the protocol;
  • Both men and women were required to be ≥ 18 and ≤ 80 years old at the time of signing the informed consent;
  • the duration of PN diagnosed by a dermatologist at the time of screening was ≥ 3 months;
  • 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

：

  • 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

Treatment and study plan

Placebo

Drug

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

Primary outcomes

  1. Proportions of subjects achieving WI-NRS

    Time frame: week 24

    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

Secondary outcomes

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

    Time frame: week 24

    Proportion of subjects with overall disease score of 0/1

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

  3. The absolute value and percentage change of weekly mean WI-NRS 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;

  4. Duration of onset of response to pruritus

    Time frame: From baseline to week 56

    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).

  5. the first response to pruritus occurred.

    Time frame: from baseline to the week 24

    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)

  6. The time when the first intergroup response difference in pruritus occurred

    Time frame: From baseline to week 24

    The time of the first intergroup response difference for pruritus (the time when the difference in the proportion of subjects with a weekly average WI-NRS score reduction of ≥ 4 points compared to the baseline first reached p < 0.05 compared with the placebo group)

  7. The duration of the difference in persistent response to pruritus between groups

    Time frame: From baseline to week 24

    The duration of the difference in persistent response between the prurity-onset groups (comparing the change in weekly WI-NRS from baseline between the MG-K10 and placebo groups, the time when the difference between the MG-K10 and placebo groups first appeared to be p < 0.05 and remained significant on subsequent measures)

  8. Proportion of subjects with an IGA PN-S score of 0/1

    Time frame: From baseline to week 56

    Proportion of subjects with IGA PN-S score of 0/1 at each evaluation visit

  9. Changes in IGA PN-S scores

    Time frame: From baseline to week 56

    Changes in IGA PN-S scores from baseline at each evaluation site

  10. Proportion of subjects with an IGA PN-A score of 0/1

    Time frame: From baseline to week 56

    Proportion of subjects with an IGA PN-A score of 0/1 from baseline to each visit point

  11. Changes in IGA PN-A scores from baseline

    Time frame: From baseline to week 56

    Changes in IGA PN-A scores from baseline at each evaluation visit

  12. Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1

    Time frame: From baseline to week 56

    Proportion of subjects with weekly WI-NRS improvement (decrease) of ≥ 4 points from baseline and IGA PN-S of 0/1 at each evaluation visit

  13. Changes in DLQI scores from baseline

    Time frame: From baseline to week 56

    Change in Dermatology Life Quality Index (DLQI) from baseline at each evaluation visit

  14. Changes in HADS from baseline

    Time frame: From baseline to week 56

    Changes in Hospital Anxiety and Depression Scale(HADS) from baseline at each evaluation site

  15. safety

    Time frame: From baseline to week 56

    These include Treatment Emergent Adverse Events (TEAE) and Serious Adverse events Events (SAE), adverse events of special interest (AESI), clinical laboratory tests, vital signs, physical examination, and abnormalities in 12-lead electrocardiograms;

  16. pharmacokinetics

    Time frame: From baseline to week 56

    Ctrough (valley concentration) change over time;

  17. pharmacodynamics

    Time frame: From baseline to week 56

    Changes of biomarkers before and after administration

  18. immunogenicity

    Time frame: From baseline to week 56

    Occurrence of Anit-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb)

Study contacts

Contact information is provided by the study sponsor or research team.

xiaofeng xiao Cai, bachelor

CONTACT

[email protected]

02151371305

Sponsors and collaborators

Lead sponsor

Shanghai Mabgeek Biotech.Co.Ltd

Industry

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.