A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Launched by SANOFI · Jan 5, 2024
Trial Information
Current as of May 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the long-term safety and tolerability of a medication called itepekimab for people with Chronic Obstructive Pulmonary Disease (COPD). It's designed for patients who have already participated in earlier studies and are looking to see how well they can handle continued treatment. The study will last up to 72 weeks, including 52 weeks of treatment and a 20-week follow-up period. Participants will have a total of 7 in-person visits and 5 phone check-ins during the study.
To be eligible for this trial, participants must have completed the treatment phase of a previous itepekimab study and should not have had serious health issues such as certain types of cancer or severe infections during that time. This trial is open to adults aged 18 and older, and it aims to gather more information about how safe the treatment is over the long term. If you or someone you know has COPD and is interested, it’s important to discuss this opportunity with a healthcare provider to see if it might be a good fit.
Gender
ALL
Eligibility criteria
- 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.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chengdu, , China
Adairsville, Georgia, United States
Caba, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Mendoza, , Argentina
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Santiago, Reg Metropolitana De Santiago, Chile
Quillota, Valparaíso, Chile
Xuzhou, , China
Jindrichuv Hradec Iii, , Czechia
Tbilisi, , Georgia
Tbilisi, , Georgia
Palaio Faliro, Athens, , Greece
Gödöllö, , Hungary
Mosonmagyaróvár, , Hungary
Hyderabad, , India
Jaipur, , India
Kozhikode, , India
Nagpur, , India
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Bialystok, Podlaskie, Poland
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Kaohsiung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Huntersville, North Carolina, United States
Rosario, Santa Fe, Argentina
Salvador, Bahia, Brazil
Vitoria, Espírito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Botucatu, São Paulo, Brazil
Sao Bernardo Do Campo, São Paulo, Brazil
Gabrovo, , Bulgaria
Sherwood Park, Alberta, Canada
Ajax, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Windsor, Ontario, Canada
Sherbrooke, Quebec, Canada
Trois Rivieres, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Tartu, , Estonia
Lyon, , France
Tbilisi, , Georgia
Berlin, , Germany
Frankfurt Am Main, , Germany
Koblenz, , Germany
Leipzig, , Germany
Leipzig, , Germany
Lübeck, , Germany
Mainz, , Germany
Rosenheim, , Germany
Budapest, , Hungary
Puspokladany, , Hungary
Szombathely, , Hungary
Wonju, Gangwon Do, Korea, Republic Of
Kaunas, , Lithuania
Durango, , Mexico
Breda, , Netherlands
Lørenskog, , Norway
Aveiro, , Portugal
Madrid / Madrid, Madrid, Comunidad De, Spain
Pozuelo De Alarcón, Madrid, Spain
Madrid, , Spain
Málaga, , Spain
Zaragoza, , Spain
Ankara, , Turkey
Chertsey, Surrey, United Kingdom
Bradford, , United Kingdom
Liverpool, , United Kingdom
Milton Keynes, , United Kingdom
Buenos Aires, Ciudad De Buenos Aires, Argentina
Talca, Maule, Chile
Mersin, , Turkey
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Istanbul, , Turkey
Rosario, Santa Fe, Argentina
Changchun, , China
Barcelona, Barcelona [Barcelona], Spain
Portsmouth, Hampshire, United Kingdom
Santiago, Reg Metropolitana De Santiago, Chile
Miami Lakes, Florida, United States
Tampa, Florida, United States
Shreveport, Louisiana, United States
Webster, Texas, United States
Cordele, Georgia, United States
Lathrup Village, Michigan, United States
Durban, , South Africa
Boulder, Colorado, United States
Boynton Beach, Florida, United States
Debary, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Windsor, , Canada
Miami, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Covington, Louisiana, United States
Bangor, Maine, United States
Saint Charles, Missouri, United States
Mckinney, Texas, United States
Kurume Shi, Fukuoka, Japan
Himeji Shi, Hyogo, Japan
Kiyose City, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Victoriaville, Quebec, Canada
Tucson, Arizona, United States
Loxahatchee Groves, Florida, United States
Atlanta, Georgia, United States
Peoria, Illinois, United States
Schenectady, New York, United States
Chengdu, , China
Fukuoka Shi, Fukuoka, Japan
Matsusaka Shi, Mie, Japan
Cutler Bay, Florida, United States
Edmond, Oklahoma, United States
Dubois, Pennsylvania, United States
Columbia, South Carolina, United States
Beckley, West Virginia, United States
Boulder, Colorado, United States
Miami, Florida, United States
Oviedo, Florida, United States
Pembroke Pines, Florida, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Valdivia, Los Ríos, Chile
Jinan, , China
Kure Shi, Hiroshima, Japan
Humenne, , Slovakia
Levice, , Slovakia
Los Angeles, California, United States
Miami, Florida, United States
Greenville, North Carolina, United States
Vicente Lopez, Ciudad De Buenos Aires, Argentina
Haskovo, , Bulgaria
Luebeck, , Germany
Thessaloniki, , Greece
Hajdunanas, , Hungary
India, , India
Nagpur, , India
Benoni, , South Africa
Lancaster, California, United States
Miami, Florida, United States
Boerne, Texas, United States
Caba, Buenos Aires, Argentina
Jaipur, , India
Petah Tikva, , Israel
Chandler, Arizona, United States
Aurora, Colorado, United States
Campinas, São Paulo, Brazil
Ruse, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Bendorf, , Germany
Calicut, , India
Chandigarh, , India
Kfar Saba, , Israel
Cona (Ferrara), , Italy
Nagoya Shi, Aichi, Japan
Konan Ku, Yokohama Shi, Kanagawa, Japan
Presov, , Slovakia
Durban, , South Africa
Durban, , South Africa
Palma De Mallorca, , Spain
Adana, , Turkey
Trois Rivières, Quebec, Canada
Jerusalem, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Kiyose, Tokyo, Japan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei City, , Taiwan
Akdeniz, , Turkey
Püspökladány, , Hungary
Buenos Aires, , Argentina
Buenos Aires, Ciudad De Buenos Aires, Argentina
Talca, Maule, Chile
Wonju Si, Gangwon Do, Korea, Republic Of
Chandler, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Boulder, Colorado, United States
Boynton Beach, Florida, United States
Debary, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Calhoun, Georgia, United States
Cordele, Georgia, United States
Peoria, Illinois, United States
Covington, Louisiana, United States
Bangor, Maine, United States
Saint Charles, Missouri, United States
Saint Louis, Missouri, United States
Buffalo, New York, United States
Schenectady, New York, United States
Greenville, North Carolina, United States
Huntersville, North Carolina, United States
Edmond, Oklahoma, United States
Dubois, Pennsylvania, United States
Boerne, Texas, United States
Beckley, West Virginia, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Salvador, Bahia, Brazil
Brasília, Distrito Federal, Brazil
Vitoria, Espírito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Botucatu, São Paulo, Brazil
Campinas, São Paulo, Brazil
São Bernardo Do Campo, São Paulo, Brazil
Stara Zagora, , Bulgaria
Veliko Tarnovo, , Bulgaria
Shenyang, , China
Wuhan, , China
Xuzhou, , China
Jindřichův Hradec, , Czechia
Tbilisi, , Georgia
Tbilisi, , Georgia
Palaio Faliro, , Greece
Chandigarh, , India
Nagpur, , India
Haifa, , Israel
Jerusalem, , Israel
Kefar Sava, , Israel
Ferrara, , Italy
Nagoya, Aichi, Japan
Kurume, Fukuoka, Japan
Kure, Hiroshima, Japan
Himeji, Hyogo, Japan
Yokohama, Kanagawa, Japan
Matsusaka, Mie, Japan
Tokyo, , Japan
Porto, , Portugal
Humenné, , Slovakia
Prešov, , Slovakia
Spišská Nová Ves, , Slovakia
Madrid, Madrid, Comunidad De, Spain
Ankara, , Turkey
Liverpool, , United Kingdom
Cincinnati, Ohio, United States
Gödöllő, , Hungary
Ankara, , Turkey
Doral, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
East Point, Georgia, United States
Shreveport, Louisiana, United States
Lathrup Village, Michigan, United States
Columbia, South Carolina, United States
Berazategui, Buenos Aires, Argentina
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, , Brazil
Frankfurt, , Germany
Pune, , India
Fukuoka, , Japan
Boston, Massachusetts, United States
Warren, Michigan, United States
Shanghai, , China
Xiangtan, , China
Kanpur, , India
Chandler, Arizona, United States
Rock Hill, South Carolina, United States
Beaumont, Texas, United States
Carrollton, Texas, United States
Buenos Aires, , Argentina
Vidin, , Bulgaria
Haikou, , China
Nanchang, , China
Pingxiang, , China
Shanghai, , China
Yangzhou, , China
Havlíčkův Brod, , Czechia
Nagpur, , India
Sant Boi De Llobregat, Catalunya [Cataluña], Spain
Palma, , Spain
London, , United Kingdom
Tucson, Arizona, United States
Lady Lake, Florida, United States
Miami, Florida, United States
Palmetto Bay, Florida, United States
Pembroke Pines, Florida, United States
Dunwoody, Georgia, United States
Henderson, Nevada, United States
Pittsburgh, Pennsylvania, United States
Beaumont, Texas, United States
Corsicana, Texas, United States
Houston, Texas, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Hefei, , China
Hohhot, , China
Reims, , France
Batumi, , Georgia
Cluj Napoca, , Romania
Kirikkale, , Turkey
Hounslow, , United Kingdom
La Palma, California, United States
Hannibal, Missouri, United States
La Plata, Buenos Aires, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Porto Alegre, Rio Grande Do Sul, Brazil
Beijing, , China
Madrid, , Spain
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported