A study to investigate long-term safety and tolerability of itepekimab in participants with COPD

Phase 1

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 26.1Level: PTClassification code: 10009033Term: Chronic obstructive pulmonary disease Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-508085-15-00
• Lead Sponsor: Sanofi-Aventis Recherche & Developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-08
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 708

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified