A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Public ClinicalTrials.gov record NCT06208306. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06208306
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 669 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2024 (Actual)
- Primary completion
- Sep 10, 2026 (Actual)
- Completion
- Sep 10, 2026 (Actual)
- Last update posted
- Sep 18, 2026
2024 – 2026
United States locations
- U.S. sites
- 64
- U.S. states
- 19
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Chandler Clinical Research Trials- Site Number : 8401034 | Chandler | Arizona | 85224 | — |
| Noble Clinical Research Site Number : 8401182 | Tucson | Arizona | 85704 | — |
| Tucson Clinical Research Institute- Site Number : 8401431 | Tucson | Arizona | 85712 | — |
| IMAX Clinical Trials- Site Number : 8401419 | La Palma | California | 90623 | — |
| Antelope Valley Clinical Trials Site Number : 8401003 | Lancaster | California | 93534 | — |
| Downtown L.A. Research Center- Site Number : 8401027 | Los Angeles | California | 90017 | — |
| Allianz Research Institute CO Site Number : 8402061 | Aurora | Colorado | 80014 | — |
| Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180 | Boulder | Colorado | 80301 | — |
| Helix Biomedics- Site Number : 8402049 | Boynton Beach | Florida | 33435 | — |
| Beautiful Minds Clinical Research Center Site Number : 8401201 | Cutler Bay | Florida | 33157 | — |
| Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031 | DeBary | Florida | 32713 | — |
| Science Connections, LLC Site Number : 8402045 | Doral | Florida | 33178 | — |
| Direct Helpers Research Center- Site Number : 8402065 | Hialeah | Florida | 33012 | — |
| Premier Medical Associates Site Number : 8401388 | Lady Lake | Florida | 32159 | — |
| Advanced Pulmonary Research Institute Site Number : 8402018 | Loxahatchee Groves | Florida | 33470 | — |
| Finlay Medical Research- Site Number : 8402007 | Miami | Florida | 33126 | — |
| Elite Clinical Research - Miami- Site Number : 8402009 | Miami | Florida | 33144 | — |
| DL Research Solutions- Site Number : 8401033 | Miami | Florida | 33155 | — |
| My Community Research Center Site Number : 8402060 | Miami | Florida | 33155 | — |
| Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019 | Miami | Florida | 33165 | — |
| Research Institute of South Florida- Site Number : 8401006 | Miami | Florida | 33173 | — |
| Reed Medical Research Site Number : 8401032 | Miami | Florida | 33176 | — |
| High Quality Research Site Number : 8401406 | Miami | Florida | 33184 | — |
| Deluxe Health Center Site Number : 8401188 | Miami Lakes | Florida | 33014 | — |
| Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015 | Ocala | Florida | 34470 | — |
| Heuer M.D. Research- Site Number : 8402016 | Orlando | Florida | 32819 | — |
| Florida Institute for Clinical Research Site Number : 8401013 | Orlando | Florida | 32825 | — |
| Oviedo Medical Research Site Number : 8402026 | Oviedo | Florida | 32765 | — |
| Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067 | Palmetto Bay | Florida | 33157 | — |
| Pines Care Research Center- Site Number : 8402056 | Pembroke Pines | Florida | 33024 | — |
| Tellabio International Research Services Site Number : 8401411 | Pembroke Pines | Florida | 33025 | — |
| Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008 | Tampa | Florida | 33606 | — |
| Appalachian Clinical Research Site Number : 8400024 | Calhoun | Georgia | 30701 | — |
| Private Practice - Dr. David Kavtaradze- Site Number : 8401029 | Cordele | Georgia | 31015 | — |
| Alpha Clinical Research Group - Dunwoody- Site Number : 8401190 | Dunwoody | Georgia | 30350 | — |
| Covenant Pulmonary Critical Care Site Number : 8401183 | East Point | Georgia | 30344 | — |
| OSF Saint Fracis Medical Center- Site Number : 8402024 | Peoria | Illinois | 61637 | — |
| Benchmark Research - Covington- Site Number : 8401193 | Covington | Louisiana | 70433 | — |
| Care Access - Shreveport- Site Number : 8402047 | Shreveport | Louisiana | 71105 | — |
| Private Practice - Dr. Paul Shapero- Site Number : 8401016 | Bangor | Maine | 04401 | — |
| Care Access - Boston- Site Number : 8402276 | Boston | Massachusetts | 02110 | — |
| Revive Research Institute - Lathrup Village- Site Number : 8402186 | Lathrup Village | Michigan | 48076 | — |
| Pulmonary and Medicine Associates- Site Number : 8401403 | Warren | Michigan | 48088 | — |
| Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383 | Hannibal | Missouri | 63401-6890 | — |
| Midwest Chest Consultants- Site Number : 8401002 | Saint Charles | Missouri | 63301 | — |
| Washington University- Site Number : 8402035 | St Louis | Missouri | 63110 | — |
| Henderson Clinical Trials Site Number : 8401365 | Henderson | Nevada | 89052 | — |
| VA Western New York Healthcare System Site Number : 8402050 | Buffalo | New York | 14215 | — |
| Schenectady Pulmonary and Critical Care Associates - Schenectady Main Office- Site Number : 8402029 | Schenectady | New York | 12308 | — |
| East Carolina University- Site Number : 8401022 | Greenville | North Carolina | 27858 | — |
| Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022 | Huntersville | North Carolina | 28078 | — |
| OK Clinical Research- Site Number : 8402001 | Edmond | Oklahoma | 73034 | — |
| Clinical Research Associates of Central PA - Dubois- Site Number : 8401023 | DuBois | Pennsylvania | 15801 | — |
| Allegheny General Hospital- Site Number : 8402058 | Pittsburgh | Pennsylvania | 15212 | — |
| MedTrial- Site Number : 8402048 | Columbia | South Carolina | 29204 | — |
| Clinical Research of Rock Hill Site Number : 8401008 | Rock Hill | South Carolina | 29732 | — |
| REX Clinical Trials - Beaumont- Site Number : 8401371 | Beaumont | Texas | 77701 | — |
| South Texas Medical Research Institute - TTS Research- Site Number : 8402012 | Boerne | Texas | 78006 | — |
| ClinRx Research - Carrollton- Site Number : 8401021 | Carrollton | Texas | 75007 | — |
| Corsicana Medical Research- Site Number : 8401018 | Corsicana | Texas | 75110 | — |
| The Methodist Hospital Research Institute Site Number : 8401194 | Houston | Texas | 77030 | — |
| Metroplex Pulmonary and Sleep Center Site Number : 8401015 | McKinney | Texas | 75069 | — |
| Clear Lake Specialties Research Center, PLLC Site Number : 8401025 | Webster | Texas | 77598 | — |
| Rheumatology & Pulmonary Clinic- Site Number : 8402053 | Beckley | West Virginia | 25801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 159 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06208306, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06208306 live on ClinicalTrials.gov.