A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction

Официальное название

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study, Followed by Open-label Extensions, to Evaluate the Efficacy of Oral Belumosudil in Adult Participants With Chronic Lung Allograft Dysfunction (CLAD) Following Bilateral Lung Transplantation

Обзор

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.

Вмешательства

• Препарат Belumosudil
  Tablet, Oral
• Препарат Azithromycin
  Depends on pharmaceutical presentation, Oral
• Препарат Placebo
  Tablet, Oral

Первичные конечные точки

• Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1) [Срок оценки: Baseline to Week 26]

Вторичные конечные точки (12)

• Response rate at Week 26 [Срок оценки: Baseline to Week 26]
• Absolute change from baseline to Week 26 in FEV1 [Срок оценки: Baseline to Week 26]
• Absolute change from baseline to Week 26 in percent predicted FEV1 [Срок оценки: Baseline to Week 26]
• Percent change from baseline to Week 26 in forced vital capacity (FVC) [Срок оценки: Baseline to Week 26]
• Absolute change from baseline to Week 26 in FVC [Срок оценки: Baseline to Week 26]
• Absolute change from baseline to Week 26 in percent predicted FVC [Срок оценки: Baseline to Week 26]
• Time to CLAD progression during the double-blind treatment period [Срок оценки: Baseline to Week 26]
• Time to re-transplantation or death [Срок оценки: Up to 7 days after the administration of last dose of study drug]
• Percent change from baseline to Week 26 in 6-minute walk distance [Срок оценки: Baseline to Week 26]
• Absolute change from baseline to Week 26 in 6-minute walk distance [Срок оценки: Baseline to Week 26]
• Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ) [Срок оценки: Baseline to Week 26]
• Change from baseline to Week 26 in EQ-5D-5L [Срок оценки: Baseline to Week 26]

Критерии участия

Критерии включения

• Participant ≥1 year post bilateral lung transplantation at the time of screening
• Participants presenting with CLAD Stage 1 or 2: FEV1 from >50% to 80% of post-transplant baseline at screening and at randomization
• Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at least 3 times a week) prior to randomization

Критерии исключения

• FEV1 ≤50% of the post-transplant baseline value (CLAD 3 and 4)
• Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 · 32 центра

• University of Alabama at Birmingham- Site Number : 8400026 — Birmingham
• St. Joseph's Hospital and Medical Center- Site Number : 8400019 — Phoenix
• University of California Los Angeles Medical Center- Site Number : 8400020 — Los Angeles
• Stanford University Medical Center- Site Number : 8400008 — Stanford
• Mayo Clinic in Florida- Site Number : 8400031 — Jacksonville
• Jackson Memorial Hospital- Site Number : 8400030 — Miami
• AdventHealth Orlando- Site Number : 8400023 — Orlando
• Tampa General Hospital - Tampa - General Circle- Site Number : 8400015 — Tampa
• … и ещё 24 центра

Китай · 9 центров

• Investigational Site Number : 1560004 — Пекин
• Investigational Site Number : 1560002 — Чэнду
• Investigational Site Number : 1560008 — Фучжоу
• Investigational Site Number : 1560007 — Гуанчжоу
• Investigational Site Number : 1560001 — Ханчжоу
• Investigational Site Number : 1560005 — Хэфэй
• Investigational Site Number : 1560009 — Шанхай
• Investigational Site Number : 1560003 — Wuxi
• … и ещё 1 центр

Франция · 6 центров

• Investigational Site Number : 2500005 — Le Plessis-Robinson
• Investigational Site Number : 2500006 — Marseille
• Investigational Site Number : 2500004 — Paris
• Investigational Site Number : 2500002 — Pessac
• Investigational Site Number : 2500003 — Saint-Herblain
• Investigational Site Number : 2500001 — Suresnes

Италия · 5 центров

• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano-Site Number : 3800001 — Milan
• Investigational Site Number : 3800005 — Padua
• IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)-Si — Palermo
• Fondazione IRCCS Policlinico San Matteo-Site Number : 3800003 — Pavia
• Azienda Ospedaliera Universitaria Senese UOC Malattie Respiratorie e Trapianto Polmonare-S — Siena

South Korea · 4 центра

• Investigational Site Number : 4100004 — Yangsan
• Investigational Site Number : 4100002 — Seoul
• Investigational Site Number : 4100001 — Seoul
• Investigational Site Number : 4100003 — Seoul

Испания · 4 центра

• Investigational Site Number : 7240002 — A Coruña
• Investigational Site Number : 7240003 — Barcelona
• Investigational Site Number : 7240001 — Santander
• Investigational Site Number : 7240004 — Valencia

Австралия · 3 центра

• Investigational Site Number : 0360003 — Darlinghurst
• Investigational Site Number : 0360001 — Brisbane
• Investigational Site Number : 0360002 — Murdoch

Канада · 3 центра

• Investigational Site Number : 1240002 — Edmonton
• Investigational Site Number : 1240001 — Vancouver
• Investigational Site Number : 1240004 — Toronto

Бельгия · 2 центра

• Investigational Site Number : 0560001 — Leuven
• Investigational Site Number : 0560002 — Yvoir

Чехия · 2 центра

• Investigational Site Number : 2030002 — Olomouc
• Investigational Site Number : 2030001 — Prague

Австрия · 1 центр

• Investigational Site Number : 0400001 — Vienna

Дания · 1 центр

• Investigational Site Number : 2080001 — Copenhagen

Финляндия · 1 центр

• Investigational Site Number : 2460001 — Helsinki

Германия · 1 центр

• Investigational Site Number : 2760003 — Munich

Венгрия · 1 центр

• Investigational Site Number : 3480001 — Budapest

Израиль · 1 центр

• Investigational Site Number : 3760001 — Petah Tikva

Япония · 1 центр

• Investigational Site Number : 3920001 — Tokyo

Нидерланды · 1 центр

• Investigational Site Number : 5280001 — Groningen

Швеция · 1 центр

• Investigational Site Number : 7520001 — Gothenburg

Идентификаторы

NCT: NCT06082037 · EFC17801 · U1111-1280-6777 · 2023-503462-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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