Dupilumab Asthma Sleep Study

STATUS

Recruiting
participants needed

260
sponsor

Sanofi

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Updated on 19 February 2024

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corticosteroids

eosinophil count

bronchodilator

pulmonary function test

forced expiratory volume

leukotriene receptor antagonist

fractional exhaled nitric oxide

polysomnography

dupilumab

Summary

Primary Objective:

To assess the effect of dupilumab on sleep

Secondary Objectives:

To evaluate the effect of dupilumab on additional patient reported sleep outcomes
To evaluate the effect of dupilumab on objective sleep assessment
To evaluate the effect of dupilumab on asthma symptoms
To evaluate the effect of dupilumab on lung function
To evaluate the safety of dupilumab

Description

Study duration per participant will be approximately 16 weeks and up to 29 weeks including up to 5 weeks screening period, a 12-week treatment period and up to 12 weeks post-treatment follow-up period

Details

Condition	Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma
Age	18-65 years
Treatment	Placebo, SAR231893
Clinical Study Identifier	NCT04502862
Sponsor	Sanofi
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020 Guidelines for 12 months treated with medium to high dose inhaled corticosteroid (ICS) and a second controller (ie, long-acting beta agonist, leukotriene receptor antagonist). A third controller is allowed but not mandatory. The dose regimen should be stable for at least 1 month before the study and during the screening period
	History of at least one asthma exacerbation within 1 year prior to screening. Exacerbation is defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids (oral or injectable)
	Eosinophils 150 cells/L and fractional exhaled nitric oxide (FeNO) 25 ppb during screening, prior to randomization
	Asthma control questionnaire (ACQ)-5 2.5 at screening Visit 1 and Visit 2, prior to randomization
	Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) 80% of predicted normal during screening, prior to randomization
	Exhibit bronchodilator reversibility (12% and 200 mL improvement in FEV1 post short-acting beta agonist administration) during screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 6 months prior to screening Visit 1
	Weekly average nocturnal awakenings due to asthma symptoms in the week prior to screening Visit 1 is 1
Exclusion Criteria
	Current smoker
	Former smoker for 10 years with a smoking history of >10 pack-years
	Asthma exacerbation during screening, prior to randomization
	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)
	History of or current evidence of clinically significant non-respiratory diseases that in the opinion of the investigator may interfere with the aims of the study or put the participant at undue risk
	Active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would be performed on a country by country basis, according to local guidelines if required by Regulatory Authorities or ethics boards
	Diagnosed active endoparasitic infection; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
	History of human immunodeficiency (HIV) infection or positive HIV test at screening Visit 1
	Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before screening
	Known or suspected immunodeficiency including history of invasive opportunistic infections, despite infection resolution
	Current evidence of clinically significant oncological disease
	History of systemic hypersensitivity or anaphylaxis to any biologic therapy
	Severe uncontrolled depression
	Sleep disturbances not related to asthma, including sleep apnea, hypersomnia, or insomnia secondary to chronic pain, atopic dermatitis (AD), COPD or other conditions
	Participant who works night shift (ie, any work between 8 pm and 6 am)
	Erratic sleep habits, as determined by the Investigator
	Restless leg syndrome or periodic limb movement disorder
	Chronic treatment with oral corticosteroid (OCS) for more than 2 weeks before screening Visit 1
	Participant taking sedative, anxiolytic, or hypnotic treatments, including melatonin, within 3 months before randomization
	Participant taking systemic sedative antihistamines (excluding newer generations of antihistamines) or theophylline
	Current treatment with antidepressants, lipophilic beta blockers, clonidine, opioids, or other medications known to interfere with sleep and may confound the study assessments, as determined by the Investigator
	Treatment with live (attenuated) vaccine within 4 weeks before screening Visit 1
	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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Dupilumab Asthma Sleep Study