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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT06033833

Run by

Sanofi

People needed

335

Starts

2023-09-05

Expected to finish

2026-09-29

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Helix Biomedics- Site Number : 8400029 — Boynton Beach, Florida, United States
• Savin Medical Group - Miami Lakes- Site Number : 8400015 — Miami Lakes, Florida, United States
• Pines Care Research Center- Site Number : 8400028 — Pembroke Pines, Florida, United States
• Treasure Valley Medical Research- Site Number : 8400031 — Boise, Idaho, United States
• Johns Hopkins Bayview Medical Center- Site Number : 8400012 — Baltimore, Maryland, United States
• OK Clinical Research- Site Number : 8400001 — Edmond, Oklahoma, United States
• South Texas Medical Research Institute - TTS Research- Site Number : 8400011 — Boerne, Texas, United States
• Investigational Site Number : 0320008 — La Plata, Buenos Aires, Argentina
• Investigational Site Number : 0320005 — Rosario, Santa Fe Province, Argentina
• Investigational Site Number : 0320006 — Rosario, Santa Fe Province, Argentina
• Investigational Site Number : 0320007 — Rosario, Santa Fe Province, Argentina
• Investigational Site Number : 0320004 — Buenos Aires, Argentina
• Investigational Site Number : 0320003 — Buenos Aires, Argentina
• Investigational Site Number : 0320001 — Buenos Aires, Argentina
• Investigational Site Number : 0320002 — Buenos Aires, Argentina
• Investigational Site Number : 0320009 — Buenos Aires, Argentina
• Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002 — Vitória, Espírito Santo, Brazil
• Associacao 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 Misericórdia de Porto Alegre- Site Number : 0760007 — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006 — Porto Alegre, Rio Grande do Sul, Brazil
• Clinica de Alergia Martti Antila- Site Number : 0760003 — Sorocaba, São Paulo, Brazil
• Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008 — São Paulo, Brazil
• Investigational Site Number : 1240008 — Ottawa, Ontario, Canada
• Bensch Research Associates- Site Number : 8400004 — Stockton, California, United States

Full record on ClinicalTrials.gov

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