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

Inclusion Criteria:

• The participant must be between the ages of 18 and 75 inclusive at the time ofsigning the informed consent.

• Moderate to severe asthma diagnosed by a physician for ≥ 12 months according tostages 4 and 5 of the Global Initiative for Asthma (GINA ).

• Participants on existing therapy with medium to high doses of ICS (≥500 μgfluticasone propionate daily or comparable ICS dose in combination with at least oneadditional controller (e.g., long-acting beta agonist [LABA], leukotriene receptorantagonist [LTRA], long-acting muscarinic antagonist [LAMA], methylxanthines) for atleast 3 months.

• ≥ 1 severe asthma exacerbation in the past year, with at least one exacerbationduring treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionatedaily 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 afteradministration of albuterol/salbutamol or levalbuterol/levosalbutamol at screeningor 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 marijuanawith cessation within 6 months of screening or history of >10 pack-years.

• Participants who experience a deterioration of asthma that results in emergencytreatment or hospitalization, or treatment with systemic steroids at any time from 1month prior to screening.

• Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during thescreening period including known history of COVID-19 infection within 4 weeks priorto Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO)secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection whohave not yet sufficiently recovered to participate in the procedures of a clinicaltrial.

• Active infection or history of clinically significant infection

• Known history of, or suspected, significant current immunosuppression, includinghistory of invasive opportunistic or helminthic infections despite infectionresolution or otherwise recurrent infections of abnormal frequency or prolongedduration.

• Active or latent tuberculosis (TB)

• A history of malignancy of any type (excluding basal and squamous cell skin cancerand in situ cervical carcinoma that has been excised and cured >3 years prior tobaseline).

• History of solid organ transplant.

• Hepatitis B, C or HIV.

• Pregnant or breastfeeding.

• History (within last 2 years prior to Baseline) of prescription drug or substanceabuse, including alcohol, considered significant by the Investigator.

• Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab.

• 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.

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