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Идёт набор NCT05975983

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Фаза II С лечением Idiopathic Pulmonary Fibrosis (IPF)

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: INS018_055, Placebo.
Кому может быть актуально
Состояния в реестре: Idiopathic Pulmonary Fibrosis (IPF). Базовые параметры: от 40 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

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Обзор

The purpose of this revised Phase IIa study is to demonstrate safety of INS018\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).

Подробное описание

Idiopathic pulmonary fibrosis is a fatal lung disease characterized by reduced quality of life (QoL) and a median survival of 3 to 4 years. While current standard of care (SoC) treatments including pirfenidone and nintedanib slow disease progression, they are not curative and poorly tolerated due to their toxicity profiles. To address the need for new treatments in IPF, InSilico Medicine is developing INS018\_055, a potent inhibitor of the serine/threonine kinase Traf2- and Nckinteracting kinase (TNIK).

Вмешательства

  • Препарат INS018_055
    Pharmaceutical formulation: Tablet Mode of Administration: Oral
  • Препарат Placebo
    Pharmaceutical formulation: Tablet Mode of Administration: Oral

Первичные конечные точки

  • Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE) [Срок оценки: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))]
Вторичные конечные точки (12)
  • Maximum plasma concentration (Cmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Time to reach maximum plasma concentration (Tmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Terminal elimination half-life (t1/2) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Terminal elimination rate constant (λz) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Apparent clearance (CL/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Apparent volume of distribution (Vz/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Trough plasma concentration (Ctrough) of INS018_055 and its major metabolites (INS018_063 and INS018_095) [Срок оценки: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))]
  • Relative change in Forced Vital Capacity (FVC) in mL [Срок оценки: Week 0/Visit 2 up to Week 12]

Критерии участия

Критерии включения

  • Male or female patients aged ≥40 years based on the date of the written informed consent form
  • Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
  • In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
  • Meeting all of the following criteria during the screening period:
  • FVC ≥40% predicted normal
  • DLCO corrected for Hgb ≥25% and <80% predicted normal
  • Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio >0.7 based on pre-bronchodilator value

Критерии исключения

  • Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
  • Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
  • Female patients who are pregnant or nursing
  • Abnormal ECG findings

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 12 центров
  • University of Alabama at Birmingham — Birmingham
  • HonorHealth Research Institute — Scottsdale
  • Keck School of Medicine of USC — Los Angeles
  • Florida Lung Asthma and Sleep Specialist — Celebration
  • Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando — Orlando
  • Southeastern Research Center — Winston-Salem
  • University of Oklahoma Health Sciences Center (OUHSC) — Oklahoma City
  • Temple University Hospital-Temple Lung Center — Philadelphia
  • … и ещё 4 центра

Идентификаторы

NCT: NCT05975983 · INS018-055-004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗