A study to investigate long-term safety and tolerability of itepekimab in participants with COPD (AERIFY-4)
Recruiting
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- jRCT2071230130
- Lead Sponsor
- Sanofi K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 700
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (AEs), AEs of special interest, serious AEs, 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 until the end of study visit
- Secondary Outcome Measures
Name Time Method Change from baseline of the parent studies (EFC16750, EFC16819): Pre-bronchodilatory and post-bronchodilatory forced expiratory volume in 1 second (FEV1) Baseline of the parent studies (EFC16750, EFC16819) up to Week 52 FEV1 is force expiratory volume in 1 second.
Change from Week 0 for cough and sputum assessment questionnaire (CASA-Q) Baseline up to Week 52 The CASA-Q was developed for use in COPD and chronic (non-obstructive) bronchitis patients.
Change from baseline of the parent studies (EFC16750, EFC16819): St. George's Respiratory Questionnaire (SGRQ) total score and domain scores 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.
Change from baseline of the parent studies (EFC16750, EFC16819): European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) single index score 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).
Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS 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.