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Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma

NCT05421598•Sanofi

View on ClinicalTrials.gov

Summary

This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: * The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. * The randomized treatment duration will be up to approximately 60 weeks. * The scheduled number of visits will be 13.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent.
•Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ).
•Participants on existing therapy with medium to high doses of ICS (≥500 μg fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist \[LABA\], leukotriene receptor antagonist \[LTRA\], long-acting muscarinic antagonist \[LAMA\], methylxanthines) for at least 3 months.
•≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable).
•Participants with pre-BD forced expiratory volume in 1 second (FEV1) \> 40% and \< 80% of predicted normal at the screening visit.
•5-item ACQ-5 score \>1.5 at randomization.
•Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test.
•Weight ≥40 kg and ≤150 kg at the randomization visit.

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•Chronic lung disease other than asthma.
•Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of \>10 pack-years.
•Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening.
•Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
•Active infection or history of clinically significant infection
•Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
•Active or latent tuberculosis (TB)
•A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured \>3 years prior to baseline).
•History of solid organ transplant.
+6 more criteria

Locations (113)

University of California San Diego Health Site Number : 8400026

La Jolla, California, United States

California Allergy and Asthma Medical Group, Inc. Site Number : 8400002

Los Angeles, California, United States

Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019

San Jose, California, United States

Bensch Clinical Research LLC Site Number : 8400004

Stockton, California, United States

Allianz Research Institute Site Number : 8400023

Westminster, California, United States

Helix Biomedics, LLC Site Number : 8400029

Boynton Beach, Florida, United States

Renaissance Research and Medical Group, Inc Site Number : 8400030

Cape Coral, Florida, United States

Beautiful Minds Clinical Research Center Site Number : 8400027

Cutler Bay, Florida, United States

Reliable Clinical Research, LLC Site Number : 8400020

Hialeah, Florida, United States

Savin Medical Group, LLC Site Number : 8400015

Miami, Florida, United States

Key Dates

Start Date

June 30, 2022

Primary Completion Date

October 11, 2024

Completion Date

March 20, 2025

Last Updated

October 9, 2025

Enrollment

446

ACTUAL participants

Conditions

Asthma

Interventions

Amlitelimab

DRUG

Placebo

DRUG

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

NCT07219173

Asthma

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RECRUITINGNA

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

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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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: October 9, 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

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

Inclusion Criteria

Exclusion Criteria

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)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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