A study to investigate long-term safety and tolerability of itepekimab in participants with COPD (AERIFY-4)
A study to investigate long-term safety and tolerability of itepekimab in participants with COPD (AERIFY-4)
ClinicalTrials.gov ID: NCT06208306
Sponsor: Sanofi
Information provided by: Sanofi (Responsible Party)
Last Update Posted: 2024-06-18
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
Official Title:
A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Participated in Either EFC16750 or EFC16819 Clinical Studies
Intervention / Treatment:
- Drug: Itepekimab (SAR440340)
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2024-01-11
|
| Primary Completion (Estimated) |
2026-12-01
|
| Study Completion (Estimated) |
2026-12-01
|
| Enrollment (Estimated) | 700 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
LTS18133
U1111-1295-3333 (Registry Identifier) (REGISTRY: ICTRP) 2023-508085-15 (Registry Identifier) (REGISTRY: CTIS) |