Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

Ведущий спонсор: Sanofi

Коллаборационист: Regeneron Pharmaceuticals

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate and severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up.

• Chronic Obstructive Pulmonary Disease

Тип вмешательства: Drug

Название вмешательства: Dupilumab SAR231893

Описание: Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Этикетка Arm Group: Dupilumab

Другое имя: Dupixent

Тип вмешательства: Drug

Название вмешательства: Inhaled Corticosteroid

Описание: Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

Тип вмешательства: Drug

Название вмешательства: Inhaled Long-Acting Beta Agonist

Описание: Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

Тип вмешательства: Drug

Название вмешательства: Inhaled Long-Acting Muscarinic Antagonist

Описание: Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Этикетка Arm Group: Placebo

Критерии:

Inclusion criteria: - Participants with a physician diagnosis of COPD who meet the following criteria at screening: - Current or former smokers with a smoking history of ≥10 pack-years. - Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%). - Medical Research Council (MRC) Dyspnea Scale grade ≥2. - Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough. - Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization or observation >24 hours in emergency department/urgent care facility. - Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated. - Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1. Exclusion criteria: - COPD diagnosis for less than 12 months prior to randomization. - A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. - Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. - Cor pulmonale, evidence of right cardiac failure. - Treatment with oxygen of more than 12 hours per day. - Hypercapnia requiring Bi-level ventilation. - AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period. - Respiratory tract infection within 4 weeks prior to screening, or during the screening period. - History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included). - Diagnosis of α-1 anti-trypsin deficiency. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Пол:

All

Минимальный возраст:

40 Years

Максимальный возраст:

80 Years

Здоровые волонтеры:

No

Фамилия: Trial Transparency email recommended (Toll free number for US & Canada)

Телефон: 800-633-1610

Телефон доб.: 1 then #

Argentina

Bulgaria

Canada

Chile

China

Czechia

Denmark

Finland

Germany

Hungary

Israel

Italy

Japan

Korea, Republic of

Mexico

Poland

Romania

Russian Federation

Slovakia

Spain

Sweden

Turkey

Ukraine

United States

2022-01-11

Тип: Sponsor

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Inflammation

Метка: Dupilumab

Тип: Experimental

Описание: Dupilumab administered every 2 weeks

Метка: Placebo

Тип: Placebo Comparator

Описание: Placebo dose administered every 2 weeks

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)