Status:
ACTIVE_NOT_RECRUITING
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
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 immunogenic...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06208306
Start Date
January 11 2024
End Date
December 1 2026
Last Update
June 12 2025
Active Locations (223)
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1
Chandler Clinical Research Trials- Site Number : 8401034
Chandler, Arizona, United States, 85224
2
Noble Clinical Research Site Number : 8401182
Tucson, Arizona, United States, 85704
3
Tucson Clinical Research Institute- Site Number : 8401431
Tucson, Arizona, United States, 85712
4
IMAX Clinical Trials- Site Number : 8401419
La Palma, California, United States, 90623