Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Itepekimab: Dose formulation: prefilled syringe
Unit dose strength(s) 150 mg/mL
Route of Administration: SC injection
Control Intervention1: Placebo matching itepekimab: Administered as
Sponsors
Sanofi Healthcare India Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participant must be 40 to 85 years of age inclusive, at the time of signing the informed consent. 2.Participants with a physician diagnosis of COPD for at least 1 year (based on GOLD definition). 3.Participants with a smoking history of ââ?°Â¥10 pack-years, but who are not currently smoking, and smoking cessation must have occurred ïâ??³6 months prior to Screening (Visit 1A) with an intention to quit permanently. Note: Urine cotinine levels will be tested at Screening (Visit 1A) and each subsequent visit during the study. 4.Participants with moderateââ?¬â??to-severe COPD with post-BD FEV1/FVC ratio ââ?°Â¤0.70 and a post-BD FEV1 % predicted ââ?°Â¥30% and 5.Participants with COPD Assessment Test (CAT) score ââ?°Â¥10 at Screening (Visit 1A) and Baseline/Randomization (Visit 2). 6.Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year prior to screening in a participant in whom other causes of chronic cough [eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] has been excluded). 7.Participants with SoC controller therapy, for ïâ??³3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the screening AND during the screening period, including either: Double therapy: ICS + LABA or LAMA + LABA OR Triple therapy: LAMA + LABA + ICS Participants with a documented history of high exacerbation risk defined as having had ââ?°Â¥2 moderate or ââ?°Â¥1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy: - Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics (however, use of antibiotics alone does not qualify as a moderate exacerbation unless documentation is available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). -Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility. 8.Body mass index (BMI) ââ?°Â¥18.0 kg/m2 or BMI ââ?°Â¥16.0kg/m2 for participants enrolled in East-Asian countries (Japan, South Korea, Singapore, China including Taiwan and Hong-Kong) 9.Capable of giving signed informed consent as described in Appendix 1 (Section 10.1.3) of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1.Participants with a current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18years of age and has not recurred. 2.Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1A). Participants with a confirmed positive cotinine test at Screening (Visit 1A) or Baseline/Randomization (Visit 2), in the absence of nicotine replacement therapy (NRT) with negative anabasine test at Screening (Visit 1A), are to be excluded from the study. 3.Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening (Visit 1A) that may affect the participantââ?¬•s participation in the study in the judgment of the Investigator. 4.Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of Ã?±-1 anti-trypsin deficiency, or another diagnosed pulmonary disease. 5.Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension. 6.Long-term treatment with oxygen >4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation >88%. 7.Hypercapnia requiring bilevel positive airway pressure (BiPAP). 8.Moderate or severe exacerbation of COPD (AECOPD, as defined above in I 07 within 4 weeks prior to Screening (Visit 1A) or during the screening period. 9.Prior history of/planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. 10.Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study. A specific example includes, but is not limited to, poorly controlled insulin-dependent diabetes. Male or female a) Male participants: No contraceptive measures required for this study b) Female participants: Contraceptive use by WOCBP should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 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 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 20 weeks after the last dose of study intervention. 11.Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A), or during the screening period. 12.Cardiomyopathy, as defined by Stage III-IV (New York Heart Association) cardiac failure, or other relevant cardiovascular disorder that in Investigatorââ?¬•s judgment may put the participant at risk or affect the study. 13.Uncontrolled hypertensio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)a over the 52-week placebo-controlled treatment period ââ?¬Â¢The primary estimand will be a treatment policy estimand.Timepoint: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change from baseline in pre-BD FEV1 at Week 24 -Change from baseline in post-BD FEV1 at Week 24 & at Week 52 -Change from baseline in pre-BD FEV1 at Week 52. -Time to first moderate or severe AECOPD over the 52-week placebo-controlled treatment period. -Annualized rate of severe AECOPD over the 52-week placebo-controlled treatment period. -Time to first severe AECOPD over the 52-week placebo-controlled treatment period.Timepoint: 52 weeks | — |
Countries
Argentina, Bulgaria, Chile, China, Czech Republic, Greece, Hungary, India, Italy, Mexico, Poland, Romania, Russian Federation, Slovakia, Taiwan, Ukraine, United States of America
Contacts
Public ContactSwapnil Sonje
Sanofi Healthcare India Pvt. Ltd
Outcome results
None listed