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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,127
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
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
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
Time frame: Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline to Week 24
Change from baseline in post-BD FEV1
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline to Week 24 and Week 52
Change from baseline in pre-BD FEV1
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline to Week 52
Time to first moderate or severe AECOPD
Time to first moderate or severe AECOPD over the placebo-controlled treatment period
Time frame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Annualized rate of severe AECOPD
Annualized rate of severe AECOPD over the placebo-controlled treatment period
Time frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Time to first severe AECOPD
Time to first severe AECOPD over the placebo-controlled treatment period.
Time frame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Annualized rate of corticosteroid-treated AECOPD
Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.
Time frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score
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.
Time frame: Baseline to Week 24 and Week 52
Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope)
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Change from baseline in St. George''s Respiratory Questionnaire (SGRQ) total score
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.
Time frame: Baseline to Week 24 and Week 52
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score
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.
Time frame: Baseline to Week 24 and Week 52
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
Time frame: 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)
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
Time frame: 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)
Functional itepekimab concentrations in serum
Time frame: 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
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 238 more locations