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Набор скоро начнётся NCT07620561

Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients

Фаза II С лечением Prurigo Nodularis (PN)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lebrikizumab.
Кому может быть актуально
Состояния в реестре: Prurigo Nodularis (PN). Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study

Обзор

The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).

Подробное описание

This study is a Phase II, single center, open-label, single-arm clinical trial. Study participation will last up to 32 weeks, including a 4-week screening period, a 24-week treatment period with all participants receiving lebrikizumab injections, and a 4-week safety follow up period.

Вмешательства

  • Препарат Lebrikizumab
    Participants will receive subcutaneous injections of Lebrikizumab every two weeks for 24 weeks. The first two doses will be 500 mg, and following doses will be 250 mg.

Первичные конечные точки

  • Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24 [Срок оценки: Baseline; Week 24]
  • Percentage of patients achieving an Investigator Global Assessment for Prurigo Nodularis Stage (IGA PN-S) score of 0 or 1 [Срок оценки: Baseline; Week 24]
Вторичные конечные точки (7)
  • Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 24 [Срок оценки: Baseline; Week 24]
  • Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at week 24 [Срок оценки: Baseline; Week 24]
  • Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at week 24 [Срок оценки: Baseline; Week 24]
  • Percent change from baseline in 5D-Pruritus Scale at week 24 [Срок оценки: Baseline; Week 24]
  • Percent change from baseline in Prurigo Activity Score (PAS) at week 24 [Срок оценки: Baseline; Week 24]
  • Percent change from baseline in HADS anxiety and depression scale at week 24 [Срок оценки: Baseline; Week 24]
  • Percent change from baseline in Patient Global Impression of Change (PGIC) at week 24 [Срок оценки: Baseline; Week 24]

Критерии участия

Критерии включения

  • Age 18-80
  • Diagnosis of Prurigo Nodularis (PN) for at least 1 year
  • Active PN with moderate-to-severe itch, several nodules, and presence of nodules in more than one part of the body
  • Women of childbearing potential must agree to remain abstinent or use a highly effective contraceptive method during treatment and for at least 18 weeks after the last dose of study drug
  • Male participants must agree to use an effective barrier contraceptive if sexually active with a woman of childbearing potential during treatment and for at least 18 weeks after the last dose of study drug

Критерии исключения

  • Prior participation in a lebrikizumab study
  • History of anaphylaxis
  • History of or active HIV
  • Active hepatitis or known liver cirrhosis
  • History of cancer in the past 5 years, except for fully treated early cervical cancer in situ or non-melanoma skin cancers (basal cell or squamous cell skin cancer) that have been successfully treated and resolved. This includes certain skin lymphomas such as mycosis fungoides.
  • Uncontrolled chronic conditions that may require intermittent oral steroid use, such as severe uncontrolled asthma
  • Current or recent parasitic infection
  • Immunocompromised individuals
  • Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study period
  • Use of other treatments for PN during the study, such as topical, systemic, or light-based treatments
  • Current or recent treatment with biologic drugs
  • Use of drugs that have an effect on the immune system during the study and within 4 weeks of starting the study
  • Receipt of phototherapy or light-based therapy within 4 weeks before starting the study
  • Regular use of tanning booths or parlors within 4 weeks before starting the study
  • Receipt of a live vaccine within 12 weeks before starting the study or planned receipt during the study
  • Recent use of an experimental drug

Other protocol-defined Inclusion/Exclusion Criteria apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UM Dermatology at UM Professional Building — Baltimore

Идентификаторы

NCT: NCT07620561 · J2T-NS-X002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗