The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma

Current smoker (cigarette or e-cigarette) or cessation of smoking within 1 year prior randomization

Previous smoker with a smoking history \>10 pack-years

Known hypersensitivity to dupilumab or any of its excipients

A subject who experiences an asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids) during screening

Current acute bronchospasm or status asthmaticus

Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts

History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, etc)

Active tuberculosis, latent untreated tuberculosis or a history of incompletely treated tuberculosis or non-tuberculous mycobacterial infection unless it is well documented by a specialist that the participants has been adequately treated and the treatment with a biologic agent can be initiated, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would only be performed on a country by country basis according to the routine clinical practice and the local guidelines, if required by regulatory authorities or ethics committees

History of or current evidence of clinically significant disease in any non-respiratory system (e.g. cardiovascular, hepatic, nervous system, gastrointestinal, endocrinological, rheumatological, dermatological), which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study

Current evidence of clinically significant oncological disease, which in the opinion of the investigator may interfere with the objectives of the study or put the subject at undue risk

Participants with any of the following results at V1:

* Positive (or indeterminate) hepatitis B surface antigen (HBs Ag) or

* Positive Hepatitis B IgM core antibody (IgM HBc Ab) or

* Positive total hepatitis B core antibody (total HBc Ab) confirmed by positive HBV DNA or

* Positive hepatitis C antibody (HCV Ab) confirmed by positive HCV RNA

History of human immunodeficiency virus (HIV) infection or positive HIV serology at V1

Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant within 3 months prior to V1

Treatment with live (attenuated) vaccine within 4 weeks before V1. For participants who have vaccination with live, attenuated vaccines planned during the course of the study (based on national vaccination schedule/local guidelines), it will be determined, after consultation with a physician, whether the administration of vaccine can be postponed until after the end of the study, or preponed to before the start of the study without compromising the health of the participant:

* Participants for whom administration of live (attenuated) vaccine can be safely postponed would be eligible to enroll into the study.

* Participants who have their vaccination preponed can enroll in the study only after a gap of 4 weeks following administration of the vaccine.

Treatment with oral corticosteroids (OCS) within 2 weeks prior to V1

Enrolled in other ongoing studies regardless of the investigational product

Treatment with an investigational drug within 1 month or within 5 half-lives (if known), whichever is longer, prior to V1

Suspected or high risk of parasitic infection (helminthic infection), unless clinical and (if necessary) laboratory assessments have ruled out active infection prior to randomization

Females who are lactating, breastfeeding, or who are pregnant

Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized

Participants are dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH GCP Ordinance E6)

Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals

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

Any country-related specific regulation that would prevent the subject from entering the study

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

What this study is about