Chronic Obstructive Pulmonary Disease
Conditions
Sponsors
Tanaka Tomoyuki
Eligibility
Sex/Gender
All
Inclusion criteria
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 visit occurred no later than 3 days before the enrolment visit of this study.
Exclusion criteria
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 or other infections whose nature or course may suggest an immunocompromised status - Anaphylactic reactions or systemic allergic reactions that are related to investigational medicinal product (IMP) and require treatment during the parent study - Any situation that led to a permanent premature IMP discontinuation in parent trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events (AEs), AEs of special interest, serious AEs, and AEs leading to permanent treatment discontinuation [Time Frame: Baseline up to Week 72] All AEs (serious or nonserious) will be collected from the signing of the informed consent form until the end of study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional itepekimab concentrations in serum [Time Frame: Baseline up to Week 52] 2. Incidence of treatment-emergent anti-drug antibody responses [Time Frame: Baseline up to Week 72] 3. Annualized rate of moderate-to-severe acute exacerbation of COPD (AECOPD) [Time Frame: Baseline up to Week 52] 4. Annualized rate of severe AECOPD [Time Frame: Baseline up to Week 52] 5. Time to first moderate-to-severe AECOPD [Time Frame: Baseline up to Week 52] 6. Time to first severe AECOPD [Time Frame: Baseline up to Week 52] 7. Change from baseline of the parent studies (EFC16750, EFC16819): Pre-bronchodilatory and post-bronchodilatory forced expiratory volume in 1 second (FEV1) [Time Frame: Baseline of the parent studies (EFC16750, EFC16819) up to Week 52] FEV1 is force expiratory volume in 1 second. 8. Change from baseline of the parent studies (EFC16750, EFC16819): St. George's Respiratory Questionnaire (SGRQ) total score and domain scores [Time Frame: Baseline of the parent studies (EFC16750, EFC16819) up to Week 52] The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. 9. Change from baseline of the parent studies (EFC16750, EFC16819): European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) single index score [Time Frame: Baseline of the parent studies (EFC16750, EFC16819) up to Week 52] The EQ-5D-5L is a standardized health-related quality-of-life questionnaire which consists of a descriptive system and the EuroQol visual analog scale (EQ-VAS). 10. Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS [Time Frame: Baseline of the parent studies (EFC16750, EFC16819) up to Week 52] The EQ-VAS records the participant's self-rated health on a vertical VAS. 11. Change from Week 0 for cough and sputum assessment questionnaire (CASA-Q) [Time Frame: Baseline up to Week 52] The CASA-Q was developed for use in COPD and chronic (non-obstructive) bronchitis patients. | — |
Countries
Chile, Japan, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed