Идёт набор NCT06806592

A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases

Фаза III С лечением Interstitial Lung Diseases Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

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: Nerandomilast, Placebo matching nerandomilast.
Кому может быть актуально: Состояния в реестре: Interstitial Lung Diseases, Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases. Базовые параметры: от 18 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, Австралия, Австрия, Китай, Франция +11
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 Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over at Least 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)

Обзор

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Вмешательства

Препарат Nerandomilast
Nerandomilast
Препарат Placebo matching nerandomilast
Placebo matching nerandomilast

Первичные конечные точки

Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26 [Срок оценки: At baseline and at Week 26]

Вторичные конечные точки (7)

Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26 [Срок оценки: At baseline and at Week 26]
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26 [Срок оценки: At baseline and at Week 26]
Absolute change from baseline in vascular volume [%] on HRCT at Week 26 [Срок оценки: At baseline and at Week 26]
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26 [Срок оценки: At baseline and at Week 26]
Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at baseline [Срок оценки: At baseline and at Week 52]
Time to first supplemental oxygen use during the trial for oxygen non-users at baseline [Срок оценки: Up to Week 52]
Occurrence of infection-related adverse events (AEs) from baseline over the duration of the trial [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as

Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or mixed connective tissue disease (MCTD) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive)
Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent >10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review
No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:

No improvement in absolute forced vital capacity (FVC) % predicted >5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted >5% are acceptable if the overall trend of FVC % predicted is declining or stable; note 2: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1)
No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator)
FVC ≥45% of predicted normal at Visit 1
Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1
Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) prior to visit 2, with the following specifications:

If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2
If using rituximab, participants must have completed their first cycle >6 months prior to Visit 2
If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2
In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned
Further inclusion criteria apply

Критерии исключения

Organising pneumonia as predominant pattern in the HRCT
Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) <0.7 at Visit 1
Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement
Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period
Any suicidal behaviour in the past 2 years
Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2
Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1
Further exclusion criteria apply

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

США · 33 центра

University of Alabama at Birmingham — Birmingham
Mayo Clinic-Arizona — Scottsdale
University of California Los Angeles — Los Angeles
Paradigm Clinical Research - San Diego — San Diego
National Jewish Health — Denver
Yale University School of Medicine — New Haven
Meris Clinical Research-Brandon-69466 — Brandon
Miami VA Healthcare System — Miami
… и ещё 25 центров

Германия · 18 центров

Charité - Universitätsmedizin Berlin — Berlin
Immanuel-Krankenhaus GmbH — Berlin
Universitätsklinikum Bonn AöR — Bonn
Städtisches Klinikum Braunschweig gGmbH — Braunschweig
Gesundheit Nord gGmbH | Klinikverbund Bremen — Bremen
Krankenhaus Porz am Rhein gGmbH — Cologne
Universitätsklinikum Düsseldorf — Düsseldorf
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH — Essen
… и ещё 10 центров

Китай · 17 центров

Beijing Chao-Yang Hospital — Пекин
China-Japan Friendship Hospital — Пекин
Peking Union Medical College Hospital — Пекин
West China Hospital, Sichuan University — Чэнду
People's Hospital of Sichuan Province — Чэнду
Guangdong Provincial People's Hospital — Гуанчжоу
The First Affiliated Hospital, Zhejiang University — Ханчжоу
The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу
… и ещё 9 центров

Япония · 15 центров