A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease

Официальное название

AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Обзор

The purpose of this clinical trial is to learn about the effects and safety of the study medicine PF-07275315 for the potential treatment of COPD. COPD is a condition that makes it difficult to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: * Are 35 to 80 years old * Have had moderate-to-severe COPD for at least 12 months * Have a documented history of at least 2 moderate or severe exacerbations within the last 12 months * Have been continuously taking their regular maintenance treatment(s) for COPD over at least 6 months at a stable dose for 3 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. We will compare the results of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants who will be involved in the Phase 2 part of the study for about 40 weeks. During this time, they will have 11 visits at the study clinic. Participants who will be involved in the Phase 3 part of the study for about 68 weeks. During this time, they will have 18 visits at the study clinic.

Вмешательства

• Препарат PF-07275315 dose 1
  SC injection dose 1
• Препарат PF-07275315-dose 2
  SC injection dose 2
• Препарат Placebo
  SC injection matched
• Препарат PF-07275315-dose 3
  SC injection dose 3

Первичные конечные точки

• Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 [Срок оценки: Baseline to Week 24]
• Phase 3 part: Annualized rate of moderate or severe ECOPD [Срок оценки: Baseline to Week 52]

Вторичные конечные точки (12)

• Phase 2: Annualized rate of moderate or severe ECOPD. [Срок оценки: Baseline to Week 24]
• Phase 2: Change from baseline in pre-BD FEV1 up to Week 24. [Срок оценки: Baseline to Week 24]
• Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24 [Срок оценки: Baseline to Week 24]
• Phase 2: Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24. [Срок оценки: Baseline to Week 24]
• Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24. [Срок оценки: Baseline to Week 24]
• Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study. [Срок оценки: Baseline to Week 24]
• Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation. [Срок оценки: Baseline to Week 24]
• Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. [Срок оценки: Baseline to Week 24]
• Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52. [Срок оценки: Baseline to Week 52]
• Phase 3: Percentage of participants with ≥4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52. [Срок оценки: Baseline to Week 52]
• Phase 3: Percentage of participants with ≥2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52. [Срок оценки: Baseline to Week 52]
• Phase 3: Percentage of participants with ≥2 points improvement from baseline in E-RS:COPD total score at Week 52. [Срок оценки: Baseline to Week 52]

Критерии участия

Критерии включения

• Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition).
• Spirometry values (post-bronchodilator forced expiratory volume in 1 second \[FEV1\]/forced vital capacity \[FVC\] less than \[<\] 70 percent (%) and post-bronchodilator FEV1 % predicted <70%, but greater than equal to 30%).
• Continuous treatment with standard of care triple therapy of LABA + LAMA + ICS for ≥ 6 months prior to Screening Visit 1 and at a stable dose for ≥3 months
• Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening.

Критерии исключения

• Significant pulmonary disease other than COPD.
• Requirement for continuous chronic treatment with oxygen at >4.0 liters / minute by nasal cannula or equivalent.
• Hypoxemia with a resting SpO2 <88% while breathing ambient air (or on the participant's usual level of oxygen supplementation).
• Clinically significant cardiovascular disease, acute and/or severe left heart failure, or heart failure partial ejection fraction, and/or cor pulmonale.

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 · 57 центров

• University of Alabama at Birmingham Lung Health Center — Birmingham
• SEC Clinical Research — Dothan
• Pulmonary Associates of Mobile, P.C. — Mobile
• Chandler Clinical Trials — Chandler
• Pulmonary Associates, PA — Phoenix
• IMAX Clinical Trials — La Palma
• NewportNativeMD, Inc. — Newport Beach
• California Medical Research Associates — Northridge
• … и ещё 49 центров

Китай · 11 центров

• The People's Hospital of Chizhou — Chizhou
• China-Japan Friendship Hospital — Пекин
• The Third Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The First People's Hospital of Xinxiang — Xinxiang
• Inner Mongolia People's Hospital — Hohhot
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot
• Zhongda Hospital Southeast University — Нанкин
• Jiangxi Provincial People's Hospital — Nanchang
• … и ещё 3 центра

Индия · 9 центров

• KLES Dr. Prabhakar Kore Hospital and Medical Research Centre — Belagavi
• Bhaktivedanta Hospital and Research Institute — Thane
• Sir Ganga Ram Hospital — New Delhi
• Jawahar Lal Nehru Medical College — Ajmer
• Maharaja Agrasen Superspeciality Hospital — Jaipur
• Hindusthan Hospital — Coimbatore
• Kamineni Hospitals Private Limited — Hyderabad
• … и ещё 2 центра

Япония · 9 центров

Список центров уточняется — проверьте первичный протокол.

Тайвань · 7 центров

Список центров уточняется — проверьте первичный протокол.

South Korea · 5 центров

Список центров уточняется — проверьте первичный протокол.

Канада · 3 центра

• Synergy Respiratory Care — Sherwood Park
• Dr. Syed Anees Medicine Professional Corporation — Windsor
• C.I.C. Mauricie inc. — Trois-Rivières

Аргентина · 2 центра

• IDIM - Instituto de Investigaciones Metabólicas — Ciudad Autonoma de Buenos Aires
• Instituto de Salud Respiratoria - (INSARES) — Mendoza

Идентификаторы

NCT: NCT07363694 · C4531031 · 2024-518587-12-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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