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

  • STATUS
    Recruiting
  • participants needed
    153
  • sponsor
    Sanofi
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Updated on 12 November 2020
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ct scan
bronchodilator
pulmonary function test
spirometry
leukotriene receptor antagonist
fractional exhaled nitric oxide
dupilumab
airway resistance
respiratory imaging

Summary

Primary Objective:

  • To assess the effect of dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging

Secondary Objective:

  • To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
  • To evaluate safety of dupilumab

Description

The study duration for each participant will be a total of minimum 29 weeks and up to 41 weeks. This includes 4 weeks +/-1 week screening period, 24 weeks of treatment period and a follow-up period up to 12 weeks or until the patients switch to commercialized dupilumab (or other biologic products), whatever comes first.

Details
Condition Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma
Age 18years - 70years
Treatment Placebo, Dupilumab SAR231893
Clinical Study IdentifierNCT04400318
SponsorSanofi
Last Modified on12 November 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

to 70 years of age inclusive with the diagnosis of asthma based on Global Strategy for Asthma Management and Prevention (GINA) 2019 at the time of signing the informed consent
History of 1 exacerbation (s) in the previous year
Uncontrolled moderate to severe asthma (ACQ-5 1.5) at V1 and V2, prior to randomization
Pre-bronchodilator FEV1 80% of predicted normal at V1 and V2, prior to randomization
Exhibit bronchodilator reversibility (12% and 200 mL improvement in FEV1 post SABA administration) during screening, prior to randomization
Blood eosinophil 300 cells /L and FeNO 25 ppb during screening, prior to randomization
Existing treatment with medium to high dose ICS in combination with a second controller (e.g. LABA, LTRA) a third controller. The dose regimen should be stable 1 month prior V1 and during screening

Exclusion Criteria

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
Asthma exacerbation during the screening, prior to randomization
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 patient 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, 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 Visit (V) 1
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 V 1
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 12 weeks before V1
Chronic treatment with oral corticosteroids (OCS) for more than 2 weeks before V1
Enrolled in other ongoing studies regardless of the investigational product
Treatment with an investigational drug within 8 weeks 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
Patients are dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH GCP Ordinance E6)
Patients 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
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