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

Chronic Obstructive Pulmonary Disease Clinical Trial

— AERIFY-4  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208306
• Other study ID #: LTS18133
• Secondary ID: U1111-1295-33332
• Status: Recruiting
• Phase: Phase 3
• Start date: January 11, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Itepekimab (SAR440340)
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
• Placebo
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320009	Buenos Aires	Ciudad De Buenos Aires
Argentina	Investigational Site Number : 0320004	Mendoza
Argentina	Investigational Site Number : 0320007	Rosario	Santa Fe
Argentina	Investigational Site Number : 0320008	Rosario	Santa Fe
Argentina	Investigational Site Number : 0320011	Rosario	Santa Fe
Bulgaria	Investigational Site Number : 1000003	Stara Zagora
Canada	Investigational Site Number : 1240004	Sherbrooke	Quebec
Canada	Investigational Site Number : 1240006	Sherwood Park	Alberta
Canada	Investigational Site Number : 1240009	Toronto	Ontario
Canada	Investigational Site Number : 1240001	Trois-Rivieres	Quebec
Canada	Investigational Site Number : 1240018	Windsor
Chile	Investigational Site Number : 1520005	Quillota	Valparaíso
Chile	Investigational Site Number : 1520001	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520002	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520003	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520007	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520006	Talca	Maule
Chile	Investigational Site Number : 1520008	Valdivia	Los Ríos
China	Investigational Site Number : 1560009	Chengdu
China	Investigational Site Number : 1560002	Jinan
China	Investigational Site Number : 1560007	Xuzhou
Czechia	Investigational Site Number : 2030001	Jindrichuv Hradec III
Hungary	Investigational Site Number : 3480002	Mosonmagyaróvár
Hungary	Investigational Site Number : 3480003	Puspokladany
Israel	Investigational Site Number : 3760008	Haifa
Israel	Investigational Site Number : 3760002	Jerusalem
Israel	Investigational Site Number : 3760004	Rehovot
Japan	Investigational Site Number : 3920003	Fukuoka-shi	Fukuoka
Japan	Investigational Site Number : 3920006	Himeji-shi	Hyogo
Japan	Investigational Site Number : 3920005	Kiyose-City	Tokyo
Japan	Investigational Site Number : 3920007	Kure-shi	Hiroshima
Japan	Investigational Site Number : 3920002	Kurume-shi	Fukuoka
Japan	Investigational Site Number : 3920001	Matsusaka-shi	Mie
Japan	Investigational Site Number : 3920004	Shinagawa-ku	Tokyo
Korea, Republic of	Investigational Site Number : 4100001	Seoul	Seoul-teukbyeolsi
Poland	Investigational Site Number : 6160001	Bialystok	Podlaskie
Poland	Investigational Site Number : 6160002	Ostrowiec Swietokrzyski	Swietokrzyskie
Portugal	Investigational Site Number : 6200006	Aveiro
Slovakia	Investigational Site Number : 7030002	Humenne
Slovakia	Investigational Site Number : 7030001	Levice
South Africa	Investigational Site Number : 7100001	Durban
Taiwan	Investigational Site Number : 1580006	Taichung
United Kingdom	Investigational Site Number : 8260005	Liverpool
United States	Appalachian Clinical Research Site Number : 8400024	Adairsville	Georgia
United States	Covenant Pulmonary Critical Care Site Number : 8401183	Atlanta	Georgia
United States	Paul A Shapero, MD, PA Site Number : 8401016	Bangor	Maine
United States	The Rheumatology and Pulmonary Clinic Site Number : 8402053	Beckley	West Virginia
United States	Care Access Site Number : 8402276	Boston	Massachusetts
United States	~Alpine Clinical Research Center Site Number : 8401180	Boulder	Colorado
United States	Helix Biomedics, LLC Site Number : 8402049	Boynton Beach	Florida
United States	Medtrial, LLC Site Number : 8402048	Columbia	South Carolina
United States	David Kavtaradze MD, Inc. Site Number : 8401029	Cordele	Georgia
United States	Benchmark Research Site Number : 8401193	Covington	Louisiana
United States	Beautiful Minds Clinical Research Center Site Number : 8401201	Cutler Bay	Florida
United States	Omega Research Site Number : 8402031	DeBary	Florida
United States	Clinical Research of Central PA Site Number : 8401023	DuBois	Pennsylvania
United States	OK Clinical Research, LLC Site Number : 8402001	Edmond	Oklahoma
United States	Advanced Respiratory and Sleep Medicine Site Number : 8400022	Huntersville	North Carolina
United States	Revive Research Institute Site Number : 8402186	Lathrup Village	Michigan
United States	Advanced Pulmonary Research Institute Site Number : 8402018	Loxahatchee Groves	Florida
United States	Metroplex Pulmonary and Sleep Center Site Number : 8401015	McKinney	Texas
United States	Finlay Medical Research Corp. Site Number : 8402007	Miami	Florida
United States	Phoenix Medical Research Site Number : 8402019	Miami	Florida
United States	Reed Medical Research Site Number : 8401032	Miami	Florida
United States	Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8402009	Miami	Florida
United States	Deluxe Health Center Site Number : 8401188	Miami Lakes	Florida
United States	Renstar Medical Research Site Number : 8402015	Ocala	Florida
United States	Florida Institute for Clinical Research Site Number : 8401013	Orlando	Florida
United States	HMD Research LLC Site Number : 8402016	Orlando	Florida
United States	Oviedo Medical Research Site Number : 8402026	Oviedo	Florida
United States	Pines Care Research Center LLC Site Number : 8402056	Pembroke Pines	Florida
United States	OSF Saint Francis Medical Center Site Number : 8402024	Peoria	Illinois
United States	Midwest Chest Consultants, P.C. Site Number : 8401002	Saint Charles	Missouri
United States	Washington University School Of Medicine / Center for Human Nutrition Site Number : 8402035	Saint Louis	Missouri
United States	Schenectady Pulmonary and Critical Care Associates Site Number : 8402029	Schenectady	New York
United States	Care Access Shreveport Site Number : 8402047	Shreveport	Louisiana
United States	Clinical Research of West Florida, Inc Site Number : 8402008	Tampa	Florida
United States	Noble Clinical Research Site Number : 8401182	Tucson	Arizona
United States	Clear Lake Specialties Research Center, PLLC Site Number : 8401025	Webster	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Chile,  China,  Czechia,  Hungary,  Israel,  Japan,  Korea, Republic of,  Poland,  Portugal,  Slovakia,  South Africa,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation	All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit	Baseline up to Week 72
Secondary	Functional itepekimab concentrations in serum		Baseline up to Week 52
Secondary	Incidence of treatmentemergent (TE) anti-drug antibody responses		Baseline up to Week 72
Secondary	Annualized rate of moderatetosevere acute exacerbation of COPD (AECOPD)		Baseline up to Week 52
Secondary	Annualized rate of severe AECOPD		Baseline up to Week 52
Secondary	Time to first moderate-to-severe AECOPD		Baseline up to Week 52
Secondary	Time to first severe AECOPD		Baseline up to Week 52
Secondary	Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1	FEV1 is force expiratory volume in 1 second	Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
Secondary	Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores	The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation.	Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
Secondary	Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score	The European Quality of Life 5 Dimensions 5 Level Version (EQ 5D 5L) is a standardized health-related quality-of-life (HRQoL) questionnaire which consists of a descriptive system and the EuroQol visual analog scale (EQ-VAS).	Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
Secondary	Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS	The EuroQol visual analog scale (EQ VAS) records the participant's self-rated health on a vertical VAS.	Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
Secondary	Change from Week 0 for CASA-Q	The cough and sputum assessment questionnaire (CASA-Q) was developed for use in COPD and chronic (non-obstructive) bronchitis patients.	Baseline up to Week 52