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

Официальное название

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.

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Proportions of subjects achieving WI-NRS [Срок оценки: week 24]

Вторичные конечные точки (12)

• Proportions of subjects achieving IGA PN-S score of 0/1 point [Срок оценки: week 24]
• The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit [Срок оценки: From baseline to week 56]
• The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit; [Срок оценки: From baseline to week 56]
• Duration of onset of response to pruritus [Срок оценки: From baseline to week 56]
• the first response to pruritus occurred. [Срок оценки: from baseline to the week 24]
• The time when the first intergroup response difference in pruritus occurred [Срок оценки: From baseline to week 24]
• The duration of the difference in persistent response to pruritus between groups [Срок оценки: From baseline to week 24]
• Proportion of subjects with an IGA PN-S score of 0/1 [Срок оценки: From baseline to week 56]
• Changes in IGA PN-S scores [Срок оценки: From baseline to week 56]
• Proportion of subjects with an IGA PN-A score of 0/1 [Срок оценки: From baseline to week 56]
• Changes in IGA PN-A scores from baseline [Срок оценки: From baseline to week 56]
• Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1 [Срок оценки: From baseline to week 56]

Критерии участия

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.

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital, Beijing, — Пекин

Идентификаторы

NCT: NCT06779136 · MG-K10-PN-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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