This is a Trial Designed to Evaluate the Combination of Nerandomilast With Mycophenolate Across a Wide Variety of Pulmonary Fibrosis Subtypes, With the Aim of Providing Clinicians With Assurance That This is an Appropriate Therapeutic Combination.

Официальное название

Nerandomilast Added to Mycophenolate for Treatment of Pulmonary Fibrosis (NERAM-PF).

Обзор

This is a trial designed to evaluate the combination of nerandomilast with mycophenolate across a wide variety of pulmonary fibrosis subtypes, with the aim of providing clinicians with assurance that this is an appropriate therapeutic combination.

Вмешательства

• Препарат Nerandomilast 18 mg - adult formulation
  Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.

Первичные конечные точки

• Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis [Срок оценки: Four months]

Вторичные конечные точки (4)

• Determine the frequency of adverse events associated with nerandomilast [Срок оценки: Four months]
• Compare rate of change in forced vital capacity (FVC) in patients treated with nerandomilast to pre-treatment rate of change [Срок оценки: Four months]
• Compare rate of change in diffusion capacity of the lung for carbon monoxide (DLCO) in patients treated with nerandomilast to pre-treatment rate of change [Срок оценки: Four months]
• Determine the rate of change in patient-reported outcome measures (PROMs) from baseline to month 4 [Срок оценки: Four months]

Критерии участия

Критерии включения

• Any underlying pulmonary fibrosis diagnosis (excluding IPF) with ≥ 10% fibrosis on chest HRCT (performed within 1 year of screening) by volume assessment as determined by the treating physician
• Anticipated benefit from nerandomilast therapy as determined by the treating physician (note that previous observed progression as defined in previous PPF clinical trials is not required prior to enrolment)
• Stable dose of mycophenolate for the preceding 3 months, with a minimum total daily dose of 1,500mg for mycophenolate mofetil or 1080mg for mycophenolate sodium
• Clinically stable for the preceding 6 weeks (did not require addition of corticosteroids for AE-ILD, or any other reason for urgent hospitalization).

Критерии исключения

• Diagnosis of IPF
• Contraindication to treatment with nerandomilast as determined by the treating physician
• FVC < 45% or DLCO < 25% based on last PFT (must be performed within 3 months of screening)
• Use of systemic prednisone > 10 mg/day for > 2 weeks within 3 months of screening (initiation of prednisone during the study is permitted if considered clinically indicated in the opinion of the treating physician)
• Use of azathioprine, cyclophosphamide, rituximab, and/or tocilizumab within 3 months of screening (initiation of azathioprine, cyclophosphamide, rituximab, and/or tocilizumab during the study is permitted if considered clinically indicated in the opinion of the treating physician)
• Use of pirfenidone and/or nintedanib within 6 weeks of screening (initiation of nintedanib and/or pirfenidone during the study is permitted if considered clinically indicated in the opinion of the treating physician)
• Significant emphysema (> 10% volume on HRCT or FEV1/FVC < lower limit of normal)
• Expected survival < 6 months as determined by the treating physician

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07570888 · 1305-0168

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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