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

Last updated: February 16, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Amlitelimab

Placebo

Clinical Study ID

NCT06033833
LTS17510
2023-503385-24
U1111-1280-5321
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with moderate-to-severe asthma who completed the treatment period ofthe parent study per protocol

  • Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg offluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/dayof fluticasone propionate or clinically comparable) in combination with a second orthird controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up toa maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) asmaintained 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

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 anestablished medical condition or require a new treatment or medication prior toenrollment, which (per Investigator's medical judgment) would adversely affect theparticipation 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 bythe Investigator

  • Any new development with the participant's disease or condition or any significantlaboratory test abnormality during the parent study that, in the opinion of theInvestigator, may present an unreasonable risk for the participant

  • Sensitivity to any of the study interventions, or components thereof, or drug orother allergy that, in the opinion of the Investigator, contraindicatesparticipation 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 theInvestigator, including medical or clinical conditions, or participants potentiallyat risk of noncompliance to study procedures

  • Participants are employees of the investigative site or other individuals directlyinvolved in the conduct of the study, or immediate family members of suchindividuals

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: Amlitelimab
Phase: 2
Study Start date:
September 05, 2023
Estimated Completion Date:
June 25, 2029

Study Description

The duration of the study for each participant will be up to 156 weeks.

Connect with a study center

  • Investigational Site Number : 0320001

    Caba, Buenos Aires C1425BEN
    Argentina

    Site Not Available

  • Investigational Site Number : 0320002

    Caba, Buenos Aires C1425FVH
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320008

    La Plata, Buenos Aires 1900
    Argentina

    Site Not Available

  • Investigational Site Number : 0320009

    Buenos Aires, Ciudad De Buenos Aires 1650
    Argentina

    Site Not Available

  • Investigational Site Number : 0320005

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Investigational Site Number : 0320006

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Investigational Site Number : 0320007

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Investigational Site Number : 0320001

    Buenos Aires, 1425
    Argentina

    Site Not Available

  • Investigational Site Number : 0320002

    Buenos Aires, 1425
    Argentina

    Site Not Available

  • Investigational Site Number : 0320003

    Buenos Aires, 1414
    Argentina

    Site Not Available

  • Investigational Site Number : 0320004

    Buenos Aires, 1121
    Argentina

    Site Not Available

  • Investigational Site Number : 0320004

    Ciudad Autonoma Bs As, C1121ABE
    Argentina

    Site Not Available

  • Investigational Site Number : 0320001

    Ciudad Autonoma Buenos Aires, C1425BEN
    Argentina

    Site Not Available

  • Investigational Site Number : 0320003

    Ciudad Autonoma Buenos Aires, C1414AIF
    Argentina

    Active - Recruiting

  • Associacao Proar- Site Number : 0760004

    Salvador, Bahia 40060-330
    Brazil

    Site Not Available

  • Proar Site Number : 0760004

    Salvador, Bahia 40060-330
    Brazil

    Active - Recruiting

  • Proar- Site Number : 0760004

    Salvador, Bahia 40060-330
    Brazil

    Active - Recruiting

  • CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760002

    Vitoria, Espírito Santo 29055 450
    Brazil

    Active - Recruiting

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

    Vitoria, Espírito Santo 29055-450
    Brazil

    Site Not Available

  • Hospital São Vicente de Paulo - Passo Fundo- Site Number : 0760001

    Passo Fundo, Rio Grande Do Sul 99010-080
    Brazil

    Site Not Available

  • Instituto Mederi de Pesquisa e Saude Site Number : 0760001

    Passo Fundo, Rio Grande Do Sul 99010-120
    Brazil

    Active - Recruiting

  • Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001

    Passo Fundo, Rio Grande Do Sul 99010-170
    Brazil

    Site Not Available

  • Hospital Sao Lucas da PUCRS Site Number : 0760006

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Active - Recruiting

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

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

    Porto Alegre, Rio Grande Do Sul 90020-090
    Brazil

    Active - Recruiting

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

    Porto Alegre, Rio Grande Do Sul 90020-090
    Brazil

    Site Not Available

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

    Porto Alegre, Rio Grande Do Sul 90020-090
    Brazil

    Site Not Available

  • Hospital das Clinicas de Sao Paulo Site Number : 0760008

    Sao Paulo, São Paulo 05403-000
    Brazil

    Site Not Available

  • Clinica de Alergia Martti Antila- Site Number : 0760003

    Sorocaba, 18040-425
    Brazil

    Site Not Available

  • Clínica de Alergia Martti Antila Site Number : 0760003

    Sorocaba, 18040-425
    Brazil

    Active - Recruiting

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Investigational Site Number : 1240008

    Ottawa, Ontario K1G 6C6
    Canada

    Site Not Available

  • Investigational Site Number : 1240007

    Trois-Rivieres, Quebec G8T 7A1
    Canada

    Site Not Available

  • Investigational Site Number : 1240007

    Trois-rivières, Quebec G8T 7A1
    Canada

    Site Not Available

  • Investigational Site Number : 1520006

    Talca, Maule 3465584
    Chile

    Site Not Available

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana De Santiago 7500692
    Chile

    Site Not Available

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana De Santiago 7750495
    Chile

    Site Not Available

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana De Santiago 8380465
    Chile

    Site Not Available

  • Investigational Site Number : 1520005

    Quillota, Valparaíso 2260877
    Chile

    Site Not Available

  • Investigational Site Number : 3480009

    Edelény, 3780
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480011

    Gã¶dã¶llã¶, 2100
    Hungary

    Site Not Available

  • Investigational Site Number : 3480011

    Gödöllö, 2100
    Hungary

    Site Not Available

  • Investigational Site Number : 3480011

    Gödöllő, 2100
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480006

    Puspokladany, 4150
    Hungary

    Site Not Available

  • Investigational Site Number : 3480006

    Püspökladány, 4150
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480012

    Szazhalombatta, 2440
    Hungary

    Site Not Available

  • Investigational Site Number : 3480012

    Százhalombatta, 2440
    Hungary

    Site Not Available

  • Investigational Site Number : 3800003

    Rome, Roma 00168
    Italy

    Site Not Available

  • Investigational Site Number : 3800004

    Naples, 80131
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800004

    Napoli, 80131
    Italy

    Site Not Available

  • Investigational Site Number : 3800003

    Roma, 00168
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800001

    Verona, 37134
    Italy

    Active - Recruiting

  • Investigational Site Number : 3920010

    Sakai, Osaka 591-8555
    Japan

    Site Not Available

  • Investigational Site Number : 3920010

    Sakai-shi, Osaka 591-8555
    Japan

    Site Not Available

  • Investigational Site Number : 3920004

    Chuo, Tokyo 104-0031
    Japan

    Site Not Available

  • Investigational Site Number : 3920004

    Chuo-ku, Tokyo 104-0031
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920005

    Chuo-ku, Tokyo 103-0027
    Japan

    Site Not Available

  • Investigational Site Number : 3920019

    Hiroshima, 732-0052
    Japan

    Site Not Available

  • Investigational Site Number : 3920019

    Hiroshima-shi, 730-0013
    Japan

    Site Not Available

  • Investigational Site Number : 3920001

    Tokyo, 140-8522
    Japan

    Site Not Available

  • Investigational Site Number : 3920005

    Tokyo, 103-0027
    Japan

    Site Not Available

  • Investigational Site Number : 4100004

    Daegu, Daegu-gwangyeoksi 42415
    Korea, Republic of

    Site Not Available

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Investigational Site Number : 4100005

    Seoul, Seoul-teukbyeolsi 05030
    Korea, Republic of

    Site Not Available

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Investigational Site Number : 4840001

    Guadalajara, Jalisco 44100
    Mexico

    Site Not Available

  • Investigational Site Number : 4840005

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Investigational Site Number : 4840002

    Chihuahua, 31000
    Mexico

    Site Not Available

  • Investigational Site Number : 4840008

    Mérida, 97070
    Mexico

    Site Not Available

  • Investigational Site Number : 4840008

    Yucatan, 97070
    Mexico

    Site Not Available

  • Investigational Site Number : 6160006

    Krakow, Malopolskie 31-209
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160004

    Bialystok, Podlaskie 15-044
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160001

    Poznan, Wielkopolskie 60-693
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160003

    Elblag, 82-300
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160002

    Gdansk, 80-405
    Poland

    Site Not Available

  • Investigational Site Number : 6160007

    Tarnow, 33-100
    Poland

    Active - Recruiting

  • Investigational Site Number : 7100007

    Benoni, 1500
    South Africa

    Active - Recruiting

  • Investigational Site Number : 7100001

    Cape Town, 7700
    South Africa

    Active - Recruiting

  • Investigational Site Number : 7100002

    Cape Town, 7530
    South Africa

    Active - Recruiting

  • Investigational Site Number : 7100007

    Johannesburg, 1500
    South Africa

    Site Not Available

  • Investigational Site Number : 7100004

    Middelburg, 1055
    South Africa

    Active - Recruiting

  • Investigational Site Number : 7920002

    Akdeniz, 33070
    Turkey

    Site Not Available

  • Investigational Site Number : 7920001

    Istanbul, 34098
    Turkey

    Site Not Available

  • Investigational Site Number : 7920003

    Izmir, 35100
    Turkey

    Site Not Available

  • Investigational Site Number : 7920005

    Izmit, 41001
    Turkey

    Site Not Available

  • Investigational Site Number : 7920008

    Kayseri, 38039
    Turkey

    Site Not Available

  • Investigational Site Number : 7920005

    Kocaeli, 41100
    Turkey

    Site Not Available

  • Investigational Site Number : 7920002

    Mersin, 33070
    Turkey

    Site Not Available

  • Investigational Site Number : 8260001

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Bensch Clinical Research LLC Site Number : 8400004

    Stockton, California 95207
    United States

    Active - Recruiting

  • Bensch Research Associates- Site Number : 8400004

    Stockton, California 95207
    United States

    Site Not Available

  • Allianz Research Institute Site Number : 8400023

    Westminster, California 92683
    United States

    Site Not Available

  • Helix Biomedics, LLC Site Number : 8400029

    Boynton Beach, Florida 33435
    United States

    Active - Recruiting

  • Helix Biomedics- Site Number : 8400029

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Savin Medical Group - Miami- Site Number : 8400015

    Miami, Florida 33126
    United States

    Site Not Available

  • Savin Medical Group, LLC Site Number : 8400015

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Savin Medical Group, LLC- Site Number : 8400015

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Pines Care Research Center LLC Site Number : 8400028

    Pembroke Pines, Florida 33023
    United States

    Active - Recruiting

  • Pines Care Research Center- Site Number : 8400028

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Treasure Valley Medical Research Site Number : 8400031

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Treasure Valley Medical Research- Site Number : 8400031

    Boise, Idaho 83706
    United States

    Site Not Available

  • Johns Hopkins Bayview Medical Center- Site Number : 8400012

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • OK Clinical Research, LLC Site Number : 8400001

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

  • OK Clinical Research- Site Number : 8400001

    Edmond, Oklahoma 73034
    United States

    Site Not Available

  • Site number 8400001

    Edmond, Oklahoma 73034-3257
    United States

    Active - Recruiting

  • South Texas Medical Research Institute - TTS Research- Site Number : 8400011

    Boerne, Texas 78006
    United States

    Site Not Available

  • TTS Research Site Number : 8400011

    Boerne, Texas 78006
    United States

    Active - Recruiting

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