Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04502862 | COMPLETED | Asthma

A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma
Sponsor:

Sanofi

Brief Summary:

Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: * To evaluate the effect of dupilumab on additional participant 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

Condition or disease

Asthma

Intervention/treatment

SAR231893

Placebo

Phase

PHASE4

Detailed Description:

Study duration per participant was 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 or until the participant switched to commercialized dupilumab (or other biologic product), whichever came first.

Study Type : INTERVENTIONAL
Estimated Enrollment : 202 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma
Actual Study Start Date : 2020-08-10
Estimated Primary Completion Date : 2023-10-03
Estimated Study Completion Date : 2023-11-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 severe asthma exacerbation within 1 year prior to screening. Severe 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/μL and fractional exhaled nitric oxide (FeNO) ≥25 ppb during screening, prior to randomization
  • * NOTES:
  • * Historical values of blood eosinophil count meeting the eligibility criterion measured within 6 months prior to screening Visit 1 in the absence of oral corticosteroid (OCS) treatment are allowed
  • * FeNO value to be checked for eligibility at Visit 2 as well
  • * 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 and at Visit 2, 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
  • * Severe 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
  • * Participant who has taken biologic therapy (including dupilumab)/systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc) within 2 months or 5 half-lives before screening Visit 1, whichever is longer
  • * Treatment with live (attenuated) vaccine within 4 weeks before screening Visit 1
  • * NOTE: 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, (i.e. after the 12 week follow-up period off-treatment or until the participant switches to commercialized dupilumab or other biologic product, whichever comes first), or preponed to before the start of the study without compromising the health of the participant:
  • * Participant for whom administration of live (attenuated) vaccine can be safely postponed would be eligible to enroll into the study
  • * Participant who have their vaccination preponed can enroll in the study only after a gap of 4 weeks following administration of the vaccine
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma

Location Details

NCT04502862

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Kern Allergy and Medical Research. Inc. Site Number : 8400003

Bakersfield, California, United States, 93301

Not yet recruiting

United States, California

Todd Astor MD Site Number : 8400016

Culver City, California, United States, 90230

Not yet recruiting

United States, California

Southern California Institute for Respiratory Diseases Site Number : 8400009

Los Angeles, California, United States, 90048

Not yet recruiting

United States, California

Allergy & Asthma Associates of Santa Clara Valley Site Number : 8400001

San Jose, California, United States, 95117

Not yet recruiting

United States, Colorado

Asthma and Allergy Associates, PC Site Number : 8400011

Colorado Springs, Colorado, United States, 80907

Not yet recruiting

United States, Florida

Sarasota Clinical Research Site Number : 8400012

Sarasota, Florida, United States, 34239

Not yet recruiting

United States, Kentucky

Allergy & Asthma Specialists, PSC Site Number : 8400004

Owensboro, Kentucky, United States, 42301

Not yet recruiting

United States, Nebraska

The Asthma and Allergy Center Site Number : 8400010

Bellevue, Nebraska, United States, 68123

Not yet recruiting

United States, Oklahola

OK Clinical Research LLC Site Number : 8400005

Edmond, Okholohan, United States, 73034

Not yet recruiting

United States, Oregon

Velocity Clinical Research, Medford Site Number : 8400007

Medford, Oregon, United States, 97504

Not yet recruiting

United States, South Carolina

National Allergy and Asthma Research, LLC Site Number : 8400008

Charleston, South Carolina, United States, 29407

Not yet recruiting

United States, Texas

TTS Research Site Number : 8400006

Boerne, Texas, United States, 78006

Not yet recruiting

Argentina, Buenos Aires

Investigational Site Number : 0320003

CABA, Buenos Aires, Argentina, C1414AIF

Not yet recruiting

Argentina, Buenos Aires

Investigational Site Number : 0320001

CABA, Buenos Aires, Argentina, C1425FVH

Not yet recruiting

Argentina, Santa Fe

Investigational Site Number : 0320004

Rosario, Santa Fe, Argentina, S2000dej

Not yet recruiting

Argentina, Santa Fe

Investigational Site Number : 0320005

Rosario, Santa Fe, Argentina, S2002OJP

Not yet recruiting

Argentina,

Investigational Site Number : 0320002

Buenos Aires, Argentina, C1121ABE

Not yet recruiting

Canada, Ontario

Investigational Site Number : 1240012

Ajax, Ontario, Canada, L1S 2J5

Not yet recruiting

Canada, Ontario

Investigational Site Number : 1240005

Toronto, Ontario, Canada, M9V 4B4

Not yet recruiting

Canada,

Investigational Site Number : 1240009

Quebec, Canada, G1G 3Y8

Not yet recruiting

Canada,

Investigational Site Number : 1240008

Windsor, Canada, N8X 5A6

Not yet recruiting

Germany,

Investigational Site Number : 2760002

Berlin, Germany, 10787

Not yet recruiting

Germany,

Investigational Site Number : 2760005

Frankfurt am Main, Germany, 60596

Not yet recruiting

Germany,

Investigational Site Number : 2760003

Hannover, Germany, 30173

Not yet recruiting

Germany,

Investigational Site Number : 2760001

Koblenz, Germany, 56068

Not yet recruiting

Germany,

Investigational Site Number : 2760004

Leipzig, Germany, 04347

Not yet recruiting

Germany,

Investigational Site Number : 2760006

Lübeck, Germany, 23552

Not yet recruiting

Italy, Cagliari

Investigational Site Number : 3800006

Monserrato, Cagliari, Italy, 09042

Not yet recruiting

Italy, Torino

Investigational Site Number : 3800001

Orbassano, Torino, Italy, 10043

Not yet recruiting

Italy,

Investigational Site Number : 3800005

Reggio Emilia, Italy, 42123

Not yet recruiting

Netherlands,

Investigational Site Number : 5280005

Arnhem, Netherlands, 6815 AD

Not yet recruiting

Netherlands,

Investigational Site Number : 5280001

Breda, Netherlands, 4818 CK

Not yet recruiting

Netherlands,

Investigational Site Number : 5280002

Leeuwarden, Netherlands, 8934 AD

Not yet recruiting

Portugal,

Investigational Site Number : 6200001

Aveiro, Portugal, 3810-501

Not yet recruiting

Portugal,

Investigational Site Number : 6200007

Guimarães, Portugal, 4810-061

Not yet recruiting

Portugal,

Investigational Site Number : 6200006

Lisboa, Portugal, 1769

Not yet recruiting

Portugal,

Investigational Site Number : 6200003

Matosinhos, Portugal, 4464-513

Not yet recruiting

Portugal,

Investigational Site Number : 6200004

Porto, Portugal, 4202-451

Not yet recruiting

Russian Federation,

Investigational Site Number : 6430001

Moscow, Russian Federation, 115093

Not yet recruiting

Russian Federation,

Investigational Site Number : 6430002

Moscow, Russian Federation, 115280

Not yet recruiting

Russian Federation,

Investigational Site Number : 6430006

Moscow, Russian Federation, 115478

Not yet recruiting

Russian Federation,

Investigational Site Number : 6430005

Moscow, Russian Federation, 117546

Not yet recruiting

Russian Federation,

Investigational Site Number : 6430007

St-Petersburg, Russian Federation, 193231

Not yet recruiting

Russian Federation,

Investigational Site Number : 6430004

St-Petersburg, Russian Federation, 194354

Not yet recruiting

Spain, GALICIA [GALICIA]

Investigational Site Number : 7240001

Lugo / Lugo, Galicia [Galicia], Spain, 27003

Not yet recruiting

Spain, Valenciana, community

Investigational Site Number : 7240002

Valencia, Valenciana, community, Spain, 46017

Not yet recruiting

Spain,

Investigational Site Number : 7240005

Madrid, Spain, 28006

Not yet recruiting

Ukraine,

Investigational Site Number : 8040002

Ivano-Frankivsk, Ukraine, 76018

Not yet recruiting

Ukraine,

Investigational Site Number : 8040006

Ivano-Frankivsk, Ukraine, 76018

Not yet recruiting

Ukraine,

Investigational Site Number : 8040003

Kharkiv, Ukraine, 61166

Not yet recruiting

Ukraine,

Investigational Site Number : 8040008

Kyiv, Ukraine, 01023

Not yet recruiting

Ukraine,

Investigational Site Number : 8040007

Kyiv, Ukraine, 01033

Not yet recruiting

Ukraine,

Investigational Site Number : 8040005

Vinnytsya, Ukraine, 21001

Not yet recruiting

United Kingdom, Cambridgeshire

Investigational Site Number : 8260001

Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ

Not yet recruiting

United Kingdom, London, City Of

Investigational Site Number : 8260002

London, London, City Of, United Kingdom, EC1M 6BQ