None listed
Conditions
Interventions
Dupilumab 300 mg q2w Type of group
Dupilumab 300 mg for SC administration is supplied as
150 mg/mL solution in 2.25 mL prefilled glass syringes to deliver 300 mg in 2.0 mL.
Group name:Placebo q2w Type of group
Placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 2 mL which will
match dupilumab 300 mg.
Sponsors
Sanofi Aventis Recherche & Development,
Eligibility
Inclusion criteria
Inclusion criteria: Age I 01. Participant must be ≥40 to ≤80 years of age, at the time of signing the informed consent. Type of participant and disease characteristics I 02. Participants with a physician diagnosis of COPD who meet the following criteria:  Current or former smokers with a smoking history of ≥10 pack-years - Current smokers are defined as those patients who are active smokers with ≥10 packyears of smoking (active smoking includes cigarettes, e-cigarettes, cigars, pipes, etc) - Former smokers are defined as those patients who were active smokers with ≥10 packyears of smoking (active smoking includes cigarettes, e-cigarettes, cigars, pipes, etc) and who have stopped smoking for at least 6 months prior to visit 1  Moderate to severe COPD (post-bronchodilator FEV1/FVC ratio 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 I 03. Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1 (Screening). Weight I 04. Body mass index (BMI) ≥16 kg/m2. Sex I 05. Male or Female Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A) Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 4 [Section 10.4], not breastfeeding, and at least one of the following conditions applies: - Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 (Section 10.4) OR - A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 (Section 10.4) during the intervention period and for at least 12 weeks after the last dose of study intervention. Informed Consent I 06. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1.2) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
Exclusion criteria: E 01. COPD diagnosis for less than 12 months prior to randomization. E 02. A patient with current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. E 03. Significant pulmonary disease other than COPD (eg, 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. E 04. Cor pulmonale, evidence of right cardiac failure. E 05. Treatment with oxygen of more than 12 hours per day. E 06. Hypercapnia requiring BiPAP. E 07. Acute exacerbation of COPD (AECOPD, as defined above in I 02) within 4 weeks prior to or during the screening period. E 08. Respiratory tract infection within 4 weeks prior to screening, or during the screening period. You could find other exclusions in section 5.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:*Moderate exacerbations are recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. **Severe exacerbations are recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for >24 hours in emergency department/urgent care facility or resulting in death Measure:Annualized rate of moderate* or severe** COPD exacerbations over the 52-week treatment period compared to placebo Timepoints:52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It will be analyzed using mixed-effect model with repeated measures (MMRM) Measure:Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo Timepoints:from baseline up to week 12 | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Colombia, France, Germany, Greece, Latvia, Lithuania, Mexico, Nederland, Poland, Portugal, Russian Federation, Serbia, South Africa, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactMiguel Angel Noel
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed