Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT04701983
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD
Secondary Objectives:
* Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
* Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
- Detailed Description
The study duration per participant:
* Screening period is 3-5 weeks
* Placebo-controlled treatment period is 52 weeks for first approximately 960 randomized participants, and 24 to 52 weeks for potential additional randomized participants
* Post-investigational medicinal product (IMP) treatment follow-up period is 20 weeks for participants not transitioning to the extension study LTS18133 Note: A long-term, double-blinded extension study (LTS18133) will be implemented to allow participants in this study to continue receiving active IMP for an additional period. Only participants completing their End-of-Treatment (EOT) visit per this study protocol will be offered to participate in the LTS18133 study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Itepekimab Q2W Itepekimab SAR440340 Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks Placebo Placebo SC administration of matching placebo Q2W for up to 52 weeks Itepekimab Q4W Itepekimab SAR440340 SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP Itepekimab Q4W Placebo SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP
- Primary Outcome Measures
Name Time Method Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
- Secondary Outcome Measures
Name Time Method Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) Baseline to Week 24 FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline in post-BD FEV1 Baseline to Week 24 and Week 52 FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline in pre-BD FEV1 Baseline to Week 52 FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time to first moderate or severe AECOPD Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Time to first moderate or severe AECOPD over the placebo-controlled treatment period
Annualized rate of severe AECOPD Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Annualized rate of severe AECOPD over the placebo-controlled treatment period
Annualized rate of corticosteroid-treated AECOPD Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation Baseline up to End-of-Study (EOS) (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133) Time to first severe AECOPD Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Time to first severe AECOPD over the placebo-controlled treatment period.
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score Baseline to Week 24 and Week 52 The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.
Functional itepekimab concentrations in serum Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133) Incidence of treatment-emergent anti-itepekimab antibodies responses Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133) Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope) Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline in St. George''s Respiratory Questionnaire (SGRQ) total score Baseline to Week 24 and Week 52 The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score Baseline to Week 24 and Week 52 The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Trial Locations
- Locations (248)
University of Alabama at Birmingham Site Number : 8400012
🇺🇸Birmingham, Alabama, United States
Jasper Summit Research Site Number : 8400178
🇺🇸Jasper, Alabama, United States
Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034
🇺🇸Chandler, Arizona, United States
Pulmonary Associates Site Number : 8400392
🇺🇸Phoenix, Arizona, United States
Noble Clinical Research Site Number : 8400182
🇺🇸Tucson, Arizona, United States
Tucson Clinical Research Institute Site Number : 8400431
🇺🇸Tucson, Arizona, United States
California Research Institute Site Number : 8400400
🇺🇸Huntington Park, California, United States
Modena Allergy + Asthma Site Number : 8400036
🇺🇸La Jolla, California, United States
Imax Clinical Trials LLC 1 Site Number : 8400419
🇺🇸La Palma, California, United States
Downtown LA Research Center Inc. Site Number : 8400027
🇺🇸Los Angeles, California, United States
Scroll for more (238 remaining)University of Alabama at Birmingham Site Number : 8400012🇺🇸Birmingham, Alabama, United States