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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

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

NCT06033833•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.

Detailed Description

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Key Dates

Start Date

September 5, 2023

Primary Completion Date

June 25, 2029

Completion Date

June 25, 2029

Last Updated

September 22, 2025

Enrollment

335

ACTUAL participants

Conditions

Asthma

Interventions

Amlitelimab

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma