Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: * The study duration will be up to 72 weeks * The treatment duration will be up to 52 weeks * A follow-up period of 20 weeks will be conducted * The number of on-site visits will be 7 and the number of phone contacts will be 5
Interventions
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
DRUGPlacebo
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
\- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.
Exclusion criteria
* Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin * Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status * Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study * Any situation that led to a permanent premature IMP discontinuation in parent trials The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation | Baseline up to Week 72 | All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent (TE) anti-drug antibody responses | Baseline up to Week 72 | — |
| Annualized rate of moderate-to-severe acute exacerbation of COPD (AECOPD) | Baseline up to Week 52 | — |
| Annualized rate of severe AECOPD | Baseline up to Week 52 | — |
| Time to first moderate-to-severe AECOPD | Baseline up to Week 52 | — |
| Time to first severe AECOPD | Baseline up to Week 52 | — |
| Functional itepekimab concentrations in serum | Baseline up to Week 52 | — |
| Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores | Baseline of the parent studies (EFC16750,EFC16819) up to Week 52 | The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. |
| Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score | Baseline of the parent studies (EFC16750,EFC16819) up to Week 52 | The European Quality of Life 5 Dimensions 5 Level Version (EQ 5D 5L) is a standardized health-related quality-of-life (HRQoL) questionnaire which consists of a descriptive system and the EuroQol visual analog scale (EQ-VAS). |
| Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS | Baseline of the parent studies (EFC16750,EFC16819) up to Week 52 | The EuroQol visual analog scale (EQ VAS) records the participant's self-rated health on a vertical VAS. |
| Change from Week 0 for CASA-Q | Baseline up to Week 52 | The cough and sputum assessment questionnaire (CASA-Q) was developed for use in COPD and chronic (non-obstructive) bronchitis patients. |
| Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1 | Baseline of the parent studies (EFC16750,EFC16819) up to Week 52 | FEV1 is force expiratory volume in 1 second |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, China, Czechia, Estonia, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed