Evaluating the Efficacy and Safety of of HSK50042 in People With Idiopathic Pulmonary Fibrosis

Официальное название

A Randomised, Double-blind, Placebo-controlled Parallel Group Phase II Clinical Study Evaluating the Efficacy and Safety of HSK50042 in Subjects With Idiopathic Pulmonary Fibrosis

Обзор

This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

Вмешательства

• Препарат HSK50042 dose 1
  HSK50042 taken orally once daily in the morning for 26 weeks.
• Препарат HSK50042 dose 2
  HSK50042 taken orally once daily in the morning for 26 weeks.
• Препарат HSK50042 dose 3
  HSK50042 taken orally once daily in the morning for 26 weeks.
• Препарат Placebo
  Placebo matching HSK50042 taken orally once daily in the morning for 26 weeks.

Первичные конечные точки

• The change from baseline in forced vital capacity (FVC) at week 12 [Срок оценки: week 12]

Вторичные конечные точки (2)

• The change from baseline in forced vital capacity (FVC) at week 26 [Срок оценки: week 26]
• The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12/26 [Срок оценки: week12/26]

Критерии участия

Критерии включения

1\. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:

• IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy.
• Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy.

2\. Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% and<90% of predicted normal at screening period.

4\. Patients have to be either:

• not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart anti fibrotic therapy.
• on stable therapy with nintedanib or pirfenidone or nerandomilast for at least 12 weeks prior to screening and during the screening period.

Критерии исключения

• Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at screening.
• In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
• Acute IPF exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined).
• History of persistent or active micturition/defecation syncope, known prior history of syncope, or concomitant other diseases increasing the risk of syncope (e.g., symptomatic bradycardia, second- or third-degree atrioventricular block, symptomatic valvular heart disease, etc.).
• Major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned during the course of the trial. (Being on a transplant list is allowed).
• Uncontrolled hypertension at screening or prior to randomization/investigational product administration (defined as refractory hypertension as assessed by the investigator, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); or hypotension (seated systolic blood pressure <100 mmHg or diastolic blood pressure <60 mmHg).
• Administration of systemic corticosteroids equivalent to >15 mg prednisone per day within 4 weeks prior to screening and/or during the screening period.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07728721 · HSK50042-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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