🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06033833
Active, not recruiting Phase 2

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

NCT06033833 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2023-09-05
Last updated
2026-05-20

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

Amlitelimab →Placebo

Amlitelimab: Injection Solution: by subcutaneous injection (SCI)

Placebo: Injection Solution: by subcutaneous injection (SCI)

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Bensch Research Associates- Site Number : 8400004 Stockton California
Helix Biomedics- Site Number : 8400029 Boynton Beach Florida
Savin Medical Group - Miami Lakes- Site Number : 8400015 Miami Lakes Florida
Pines Care Research Center- Site Number : 8400028 Pembroke Pines Florida
Treasure Valley Medical Research- Site Number : 8400031 Boise Idaho
Johns Hopkins Bayview Medical Center- Site Number : 8400012 Baltimore Maryland
OK Clinical Research- Site Number : 8400001 Edmond Oklahoma
South Texas Medical Research Institute - TTS Research- Site Number : 8400011 Boerne Texas
Investigational Site Number : 0320008 La Plata Buenos Aires
Investigational Site Number : 0320005 Rosario Santa Fe Province
Investigational Site Number : 0320006 Rosario Santa Fe Province
Investigational Site Number : 0320007 Rosario Santa Fe Province
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
Associacao Proar- Site Number : 0760004 Salvador Estado de Bahia
Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001 Passo Fundo Rio Grande do Sul
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007 Porto Alegre Rio Grande do Sul
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006 Porto Alegre Rio Grande do Sul
Clinica de Alergia Martti Antila- Site Number : 0760003 Sorocaba São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008 São Paulo Brazil
Investigational Site Number : 1240008 Ottawa Ontario
Investigational Site Number : 1240007 Trois-Rivières Quebec
Investigational Site Number : 1520006 Talca Maule Region
Investigational Site Number : 1520001 Santiago Reg Metropolitana de Santiago
Investigational Site Number : 1520003 Santiago Reg Metropolitana de Santiago
Investigational Site Number : 1520008 Santiago Reg Metropolitana de Santiago
Investigational Site Number : 1520005 Quillota Valparaiso
Investigational Site Number : 3480009 Edelény Hungary
Investigational Site Number : 3480011 Gödöllő Hungary
Investigational Site Number : 3480006 Püspökladány Hungary
Investigational Site Number : 3480012 Százhalombatta Hungary
Investigational Site Number : 3800004 Naples Napoli
Investigational Site Number : 3800003 Rome Roma
Investigational Site Number : 3800001 Verona Italy
Investigational Site Number : 3920010 Sakai Osaka
Investigational Site Number : 3920004 Chūō Tokyo

+ 28 more sites — see the full list on the official registry below.

More Sanofi trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06033833 on ClinicalTrials.gov ↗ ← All trials in the USA