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Идёт набор NCT07527923

First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis

Фаза I С лечением Healthy Volunteer Atopic Dermatitis

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: REGN20423, Placebo.
Кому может быть актуально
Состояния в реестре: Healthy Volunteer, Atopic Dermatitis. Базовые параметры: 18 лет — 65 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
Бельгия
Следующий шаг
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Официальное название

A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis

Обзор

This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans. The study is looking at: * What side effects REGN20423 might cause * How much REGN20423 is in the blood at different times * How well REGN20423 works in adults with atopic dermatitis * Whether the body makes antibodies against REGN20423 * How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others * What the best dose of REGN20423 is

Вмешательства

  • Препарат REGN20423
    Administered per the protocol
  • Другое Placebo
    Administered per the protocol

Первичные конечные точки

  • Occurrence of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 69 weeks]
  • Severity of TEAEs [Срок оценки: Up to 69 weeks]
Вторичные конечные точки (12)
  • Concentrations of REGN20423 in serum [Срок оценки: Up to 57 weeks]
  • Absolute values from baseline of total Interleukin 13 (IL-13) [Срок оценки: Up to 52 weeks]
  • Absolute values from baseline of total Immunoglobulin E (IgE) [Срок оценки: Up to 52 weeks]
  • Absolute values from baseline of total eosinophil counts in blood [Срок оценки: Up to 52 weeks]
  • Absolute values from baseline of total periostin [Срок оценки: Up to 52 weeks]
  • Absolute values from baseline of total Thymus and Activation-Regulated Chemokine (TARC) [Срок оценки: Up to 52 weeks]
  • Percent change from baseline of total IL-13 [Срок оценки: Up to 52 weeks]
  • Percent change from baseline of total IgE [Срок оценки: Up to 52 weeks]
  • Percent change from baseline of total eosinophil counts in blood [Срок оценки: Up to 52 weeks]
  • Percent change from baseline of total periostin [Срок оценки: Up to 52 weeks]
  • Percent change from baseline of total TARC [Срок оценки: Up to 52 weeks]
  • Occurrence of Anti-Drug Antibodies (ADA) to REGN20423 [Срок оценки: Up to 57 weeks]

Критерии участия

Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis

Критерии включения

Part A:

  • Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention
  • Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit

Part B:

  • Has a history of AD for at least 6 months at screening
  • Has EASI score ≥5 at both the screening and baseline visits
  • Has IGA score ≥2 at both the screening and baseline visits

Критерии исключения

Part A:

  • Hospitalized (>24 hours) for any reason within 30 days prior to the screening visit
  • Hypersensitivity to the study treatment or any of its excipients
  • History of clinical parasite infection, except treated trichomoniasis
  • Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study
  • History of alcohol or drug abuse as determined by the investigator

Part B:

  • Known or suspected history of immunosuppression
  • Presence of skin comorbidities at screening that may interfere with study assessments
  • Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list
  • Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study

Note: Other protocol defined Inclusion/ Exclusion criteria apply

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Бельгия · 1 центр
  • Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven) — Leuven

Идентификаторы

NCT: NCT07527923 · R20423-HV-2555 · 2025-524205-32-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗