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NCT06033833

PHASE2

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

Official title: A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

335

Start Date

2023-09-05

Completion Date

2029-06-25

Last Updated

2025-09-22

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

Amlitelimab

Injection Solution: by subcutaneous injection (SCI)

DRUG

Placebo

Injection Solution: by subcutaneous injection (SCI)

Inclusion Criteria: * Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol * Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent. * Contraception for male and female participants; For female participants: * incapable of becoming pregnant * not pregnant or breast feeding * not to donate or cryopreserve eggs for female participants For male participants * No sperm donation or cryopreserving sperms Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Chronic lung disease other than asthma * Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation * Current smoker or active vaping of any products and/or marijuana smoking * Prescription drug or substance abuse, including alcohol, considered significant by the Investigator * Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures * Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Locations (68)

Bensch Clinical Research LLC- Site Number : 8400004

Stockton, California, United States

Helix Biomedics, LLC - Site Number : 8400029

Boynton Beach, Florida, United States

Savin Medical Group - Miami- Site Number : 8400015

Miami, Florida, United States

Pines Care Research Center LLC- Site Number : 8400028

Pembroke Pines, Florida, United States

Treasure Valley Medical Research- Site Number : 8400031

Boise, Idaho, United States

Johns Hopkins University School of Medicine- Site Number : 8400012

Baltimore, Maryland, United States

OK Clinical Research, LLC- Site Number : 8400001

Edmond, Oklahoma, United States

TTS Research- Site Number : 8400011

Boerne, Texas, United States

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320008

La Plata, Buenos Aires, Argentina

Investigational Site Number : 0320009

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320005

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320004

Ciudad Autonoma Bs As, Argentina

Investigational Site Number : 0320003

Ciudad Autonoma Buenos Aires, Argentina

Investigational Site Number : 0320001

Ciudad Autonoma Buenos Aires, Argentina

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002

Vitória, Espírito Santo, Brazil

Proar- Site Number : 0760004

Salvador, Estado de Bahia, Brazil

Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001

Passo Fundo, Rio Grande do Sul, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760007

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas da PUCRS- Site Number : 0760006

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas de Sao Paulo- Site Number : 0760008

São Paulo, São Paulo, Brazil

Clínica de Alergia Martti Antila- Site Number : 0760003

Sorocaba, Brazil

Investigational Site Number : 1240008

Ottawa, Ontario, Canada

Investigational Site Number : 1240007

Trois-Rivières, Quebec, Canada

Investigational Site Number : 1520006

Talca, Maule Region, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520005

Quillota, Región de Valparaíso, Chile

Investigational Site Number : 3480009

Edelény, Hungary

Investigational Site Number : 3480011

Gödöllö, Hungary

Investigational Site Number : 3480006

Püspökladány, Hungary

Investigational Site Number : 3480012

Százhalombatta, Hungary

Investigational Site Number : 3800003

Rome, Roma, Italy

Investigational Site Number : 3800004

Naples, Italy

Investigational Site Number : 3800001

Verona, Italy

Investigational Site Number : 3920010

Sakai, Osaka, Japan

Investigational Site Number : 3920005

Chuo-ku, Tokyo, Japan

Investigational Site Number : 3920004

Chuo-ku, Tokyo, Japan

Investigational Site Number : 3920001

Shinagawa-ku, Tokyo, Japan

Investigational Site Number : 3920019

Hiroshima, Japan

Investigational Site Number : 4840001

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840005

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840002

Chihuahua City, Mexico

Investigational Site Number : 4840008

Mérida, Mexico

Investigational Site Number : 6160001

Poznan, Greater Poland Voivodeship, Poland

Investigational Site Number : 6160006

Krakow, Lesser Poland Voivodeship, Poland

Investigational Site Number : 6160004

Bialystok, Podlaskie Voivodeship, Poland

Investigational Site Number : 6160003

Elblag, Poland

Investigational Site Number : 6160002

Gdansk, Poland

Investigational Site Number : 6160007

Tarnów, Poland

Investigational Site Number : 7100007

Benoni, South Africa

Investigational Site Number : 7100002

Cape Town, South Africa

Investigational Site Number : 7100001

Cape Town, South Africa

Investigational Site Number : 7100004

Middelburg, South Africa

Investigational Site Number : 4100004

Daegu, Daegu, South Korea

Investigational Site Number : 4100006

Moncton, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100005

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7920001

Istanbul, Turkey (Türkiye)

Investigational Site Number : 7920003

Izmir, Turkey (Türkiye)

Investigational Site Number : 7920008

Kayseri, Turkey (Türkiye)

Investigational Site Number : 7920005

Kocaeli, Turkey (Türkiye)

Investigational Site Number : 7920002

Mersin, Turkey (Türkiye)

Investigational Site Number : 8260001

Bradford, United Kingdom

Clinical Research Directory

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)