ACTIVE_NOT_RECRUITING

A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-01-11
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06208306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin
  2. * Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status
  3. * Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study
  4. * Any situation that led to a permanent premature IMP discontinuation in parent trials

Contacts and Locations

Principal Investigator

Clinical Sciences & Operations
STUDY_DIRECTOR
Sanofi

Study Locations (Sites)

Chandler Clinical Research Trials- Site Number : 8401034
Chandler, Arizona, 85224
United States
Noble Clinical Research Site Number : 8401182
Tucson, Arizona, 85704
United States
Tucson Clinical Research Institute- Site Number : 8401431
Tucson, Arizona, 85712
United States
IMAX Clinical Trials- Site Number : 8401419
La Palma, California, 90623
United States
Antelope Valley Clinical Trials Site Number : 8401003
Lancaster, California, 93534
United States
Downtown L.A. Research Center- Site Number : 8401027
Los Angeles, California, 90017
United States
Allianz Research Institute CO Site Number : 8402061
Aurora, Colorado, 80014
United States
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180
Boulder, Colorado, 80301
United States
Helix Biomedics- Site Number : 8402049
Boynton Beach, Florida, 33435
United States
Beautiful Minds Clinical Research Center Site Number : 8401201
Cutler Bay, Florida, 33157
United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031
DeBary, Florida, 32713
United States
Science Connections, LLC Site Number : 8402045
Doral, Florida, 33178
United States
Direct Helpers Research Center- Site Number : 8402065
Hialeah, Florida, 33012
United States
Premier Medical Associates Site Number : 8401388
Lady Lake, Florida, 32159
United States
Advanced Pulmonary Research Institute Site Number : 8402018
Loxahatchee Groves, Florida, 33470
United States
Deluxe Health Center Site Number : 8401188
Miami Lakes, Florida, 33014
United States
Finlay Medical Research- Site Number : 8402007
Miami, Florida, 33126
United States
Elite Clinical Research - Miami- Site Number : 8402009
Miami, Florida, 33144
United States
DL Research Solutions- Site Number : 8401033
Miami, Florida, 33155
United States
My Community Research Center Site Number : 8402060
Miami, Florida, 33155
United States
Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019
Miami, Florida, 33165
United States
Research Institute of South Florida- Site Number : 8401006
Miami, Florida, 33173
United States
Reed Medical Research Site Number : 8401032
Miami, Florida, 33176
United States
High Quality Research Site Number : 8401406
Miami, Florida, 33184
United States
Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015
Ocala, Florida, 34470
United States
Heuer M.D. Research- Site Number : 8402016
Orlando, Florida, 32819
United States
Florida Institute for Clinical Research Site Number : 8401013
Orlando, Florida, 32825
United States
Oviedo Medical Research Site Number : 8402026
Oviedo, Florida, 32765
United States
Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067
Palmetto Bay, Florida, 33157
United States
Pines Care Research Center- Site Number : 8402056
Pembroke Pines, Florida, 33024
United States
Tellabio International Research Services Site Number : 8401411
Pembroke Pines, Florida, 33025
United States
Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008
Tampa, Florida, 33606
United States
Appalachian Clinical Research Site Number : 8400024
Calhoun, Georgia, 30701
United States
Private Practice - Dr. David Kavtaradze- Site Number : 8401029
Cordele, Georgia, 31015
United States
Alpha Clinical Research Group - Dunwoody- Site Number : 8401190
Dunwoody, Georgia, 30350
United States
Covenant Pulmonary Critical Care Site Number : 8401183
East Point, Georgia, 30344
United States
OSF Saint Fracis Medical Center- Site Number : 8402024
Peoria, Illinois, 61637
United States
Benchmark Research - Covington- Site Number : 8401193
Covington, Louisiana, 70433
United States
Care Access - Shreveport- Site Number : 8402047
Shreveport, Louisiana, 71105
United States
Private Practice - Dr. Paul Shapero- Site Number : 8401016
Bangor, Maine, 04401
United States
Care Access - Boston- Site Number : 8402276
Boston, Massachusetts, 02110
United States
Revive Research Institute - Lathrup Village- Site Number : 8402186
Lathrup Village, Michigan, 48076
United States
Pulmonary and Medicine Associates- Site Number : 8401403
Warren, Michigan, 48088
United States
Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383
Hannibal, Missouri, 63401-6890
United States
Midwest Chest Consultants- Site Number : 8401002
Saint Charles, Missouri, 63301
United States
Washington University- Site Number : 8402035
Saint Louis, Missouri, 63110
United States
Henderson Clinical Trials Site Number : 8401365
Henderson, Nevada, 89052
United States
VA Western New York Healthcare System Site Number : 8402050
Buffalo, New York, 14215
United States
Schenectady Pulmonary and Critical Care Associates - Schenectady Main Office- Site Number : 8402029
Schenectady, New York, 12308
United States
East Carolina University- Site Number : 8401022
Greenville, North Carolina, 27858
United States
Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022
Huntersville, North Carolina, 28078
United States
OK Clinical Research- Site Number : 8402001
Edmond, Oklahoma, 73034
United States
Clinical Research Associates of Central PA - Dubois- Site Number : 8401023
DuBois, Pennsylvania, 15801
United States
Allegheny General Hospital- Site Number : 8402058
Pittsburgh, Pennsylvania, 15212
United States
MedTrial- Site Number : 8402048
Columbia, South Carolina, 29204
United States
Clinical Research of Rock Hill Site Number : 8401008
Rock Hill, South Carolina, 29732
United States
REX Clinical Trials - Beaumont- Site Number : 8401371
Beaumont, Texas, 77701
United States
South Texas Medical Research Institute - TTS Research- Site Number : 8402012
Boerne, Texas, 78006
United States
ClinRx Research - Carrollton- Site Number : 8401021
Carrollton, Texas, 75007
United States
Corsicana Medical Research- Site Number : 8401018
Corsicana, Texas, 75110
United States
The Methodist Hospital Research Institute Site Number : 8401194
Houston, Texas, 77030
United States
Metroplex Pulmonary and Sleep Center Site Number : 8401015
McKinney, Texas, 75069
United States
Clear Lake Specialties Research Center, PLLC Site Number : 8401025
Webster, Texas, 77598
United States
Rheumatology & Pulmonary Clinic- Site Number : 8402053
Beckley, West Virginia, 25801
United States

Collaborators and Investigators

Sponsor: Sanofi

  • Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-11
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2024-01-11
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease