A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Chronic Obstructive Pulmonary Disease
In brief
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
Key facts
- Study ID
- NCT06208306
- Run by
- Sanofi
- People needed
- 700
- Starts
- 2024-01-11
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Noble Clinical Research Site Number : 8401182 — Tucson, Arizona, United States
- Tucson Clinical Research Institute- Site Number : 8401431 — Tucson, Arizona, United States
- IMAX Clinical Trials- Site Number : 8401419 — La Palma, California, United States
- Antelope Valley Clinical Trials Site Number : 8401003 — Lancaster, California, United States
- Downtown L.A. Research Center- Site Number : 8401027 — Los Angeles, California, United States
- Allianz Research Institute CO Site Number : 8402061 — Aurora, Colorado, United States
- Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180 — Boulder, Colorado, United States
- Helix Biomedics- Site Number : 8402049 — Boynton Beach, Florida, United States
- Beautiful Minds Clinical Research Center Site Number : 8401201 — Cutler Bay, Florida, United States
- Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031 — DeBary, Florida, United States
- Science Connections, LLC Site Number : 8402045 — Doral, Florida, United States
- Direct Helpers Research Center- Site Number : 8402065 — Hialeah, Florida, United States
- Premier Medical Associates Site Number : 8401388 — Lady Lake, Florida, United States
- Advanced Pulmonary Research Institute Site Number : 8402018 — Loxahatchee Groves, Florida, United States
- Finlay Medical Research- Site Number : 8402007 — Miami, Florida, United States
- Elite Clinical Research - Miami- Site Number : 8402009 — Miami, Florida, United States
- DL Research Solutions- Site Number : 8401033 — Miami, Florida, United States
- My Community Research Center Site Number : 8402060 — Miami, Florida, United States
- Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019 — Miami, Florida, United States
- Research Institute of South Florida- Site Number : 8401006 — Miami, Florida, United States
- Reed Medical Research Site Number : 8401032 — Miami, Florida, United States
- High Quality Research Site Number : 8401406 — Miami, Florida, United States
- Deluxe Health Center Site Number : 8401188 — Miami Lakes, Florida, United States
- Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015 — Ocala, Florida, United States
- Chandler Clinical Research Trials- Site Number : 8401034 — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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