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NCT06208306 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
A Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 700
- Enrollment target
- 20
- Study locations
NCT06208306: Active Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Sanofi.
NCT06208306 is a Phase 3 study of Chronic Obstructive Pulmonary Disease that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 700 participants, below the 1,746-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06208306, a Phase 3 study of Chronic Obstructive Pulmonary Disease, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 700 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Itepekimab (SAR440340)
Study Locations (20)
Florida
- Helix Biomedics- Site Number : 8402049 - Boynton Beach
- Beautiful Minds Clinical Research Center Site Number : 8401201 - Cutler Bay
- Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031 - DeBary
- Science Connections, LLC Site Number : 8402045 - Doral
- Direct Helpers Research Center- Site Number : 8402065 - Hialeah
- Premier Medical Associates Site Number : 8401388 - Lady Lake
- Advanced Pulmonary Research Institute Site Number : 8402018 - Loxahatchee Groves
- Finlay Medical Research- Site Number : 8402007 - Miami
- Elite Clinical Research - Miami- Site Number : 8402009 - Miami
- DL Research Solutions- Site Number : 8401033 - Miami
- My Community Research Center Site Number : 8402060 - Miami
- Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019 - Miami
Arizona
- Chandler Clinical Research Trials- Site Number : 8401034 - Chandler
- Noble Clinical Research Site Number : 8401182 - Tucson
- Tucson Clinical Research Institute- Site Number : 8401431 - Tucson
California
- IMAX Clinical Trials- Site Number : 8401419 - La Palma
- Antelope Valley Clinical Trials Site Number : 8401003 - Lancaster
- Downtown L.A. Research Center- Site Number : 8401027 - Los Angeles
Colorado
- Allianz Research Institute CO Site Number : 8402061 - Aurora
- Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180 - Boulder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2024-01-11 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 3 |
What the registry record for NCT06208306 still lists
NCT06208306 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 1,746-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06208306 names 20 study sites across 4 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT06208306 about?
NCT06208306 is a clinical study titled "A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD". 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 i...
What is the current status of trial NCT06208306?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2024-01-11. Estimated completion is 2026-12-01.
What conditions does trial NCT06208306 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT06208306?
The interventions under investigation include: Placebo (DRUG), Itepekimab (SAR440340) (DRUG).
Who is sponsoring clinical trial NCT06208306?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06208306 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06208306's enrollment target sits among peer trials
700 21st of 86 higher than 66 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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