Brief Summary

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma.

The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Conditions

• Asthma

Intervention / Treatment

• Drug: Dupilumab
• Drug: Placebo

Primary Outcome Measures

• Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population (Week 8 to Week 52)
  Rate of change from week 8 to week 52 on post-bronchodilator (BD) forced expiratory volume in one second (FEV1) slope in FeNO population.

Countries

Belgium, Brazil, Bulgaria, Canada, China, Greece, Hungary, India, Ireland, Mexico, Oman, Peru, Puerto Rico, Romania, Saudi Arabia, Slovakia, South Africa, South Korea, Taiwan, Turkey (Türkiye), United Arab Emirates, United Kingdom, United States

Locations and Investigators

• Cullman Research Center- Site Number : 8400001, Cullman, United States
• Shoals Primary Care - Sheffield- Site Number : 8400015, Sheffield, United States
• Chandler Clinical Research Trials- Site Number : 8400147, Chandler, United States
• Pulmonary Associates - Deer Valley Office- Site Number : 8400155, Phoenix, United States
• Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130, Phoenix, United States
• Del Sol Research Management - Tucson- Site Number : 8400017, Tucson, United States
• Kern Allergy and Medical Research- Site Number : 8400037, Bakersfield, United States
• Vitality Clinical Research- Site Number : 8400142, Beverly Hills, United States
• Ascada Research - Fullerton- Site Number : 8400076, Fullerton, United States
• Allergy and Asthma Specialists Medical Group- Site Number : 8400162, Huntington Beach, United States
• Newport Native MD- Site Number : 8400054, Newport Beach, United States
• Prospective Research Innovations- Site Number : 8400131, Rancho Cucamonga, United States
• Mercy Medical Group - Midtown- Site Number : 8400164, Sacramento, United States
• Integrated Research of Inland- Site Number : 8400156, Upland, United States
• Allianz Research Institute- Site Number : 8400018, Westminster, United States
• Woodland Clinic - Woodland- Site Number : 8400171, Woodland, United States
• Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035, Altamonte Springs, United States
• Florida Center for Allergy & Asthma Research- Site Number : 8400032, Aventura, United States
• Beautiful Minds Clinical Research Center- Site Number : 8400141, Cutler Bay, United States
• Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023, DeBary, United States
• Florida Lung, Asthma and Sleep Specialists (FLASS) - Polynesian- Site Number : 8400098, Kissimmee, United States
• Ivetmar Medical Group- Site Number : 8400063, Miami, United States
• My Preferred Research- Site Number : 8400073, Miami, United States
• Research Institute of South Florida- Site Number : 8400079, Miami, United States
• Floridian Clinical Research - Miami Lakes- Site Number : 8400091, Miami Lakes, United States
• Heuer M.D. Research- Site Number : 8400024, Orlando, United States
• JSV Clinical Research- Site Number : 8400150, Tampa, United States
• Appalachian Clinical Research- Site Number : 8400129, Adairsville, United States
• Alpha Clinical Research Group - Dunwoody- Site Number : 8400116, Dunwoody, United States
• Aeroallergy Research Laboratory- Site Number : 8400114, Savannah, United States
• Rush University Medical Center- Site Number : 8400146, Chicago, United States
• NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400138, Skokie, United States
• Family Allergy & Asthma - Louisville - Goss Avenue- Site Number : 8400160, Louisville, United States
• Allergy and Asthma Specialist- Site Number : 8400007, Owensboro, United States
• Avant Research Associates - Crowley- Site Number : 8400117, Crowley, United States
• Investigational Site Number : 3560016, Houma, United States
• Tandem Clinical Research - Metairie- Site Number : 8400163, Metairie, United States
• Javara Privia Mid-Atlantic - Annapolis- Site Number : 8400087, Annapolis, United States
• Urgent Care Clinical Trials and KUR Research- Site Number : 8400169, Columbia, United States
• Chesapeake Clinical Research - White Marsh- Site Number : 8400119, White Marsh, United States
• Genesis Clinical Research - Fall River- Site Number : 8400050, Fall River, United States
• University of Michigan Health System - Ann Arbor- Site Number : 8400030, Ann Arbor, United States
• Revival Research Institute - Dearborn- Site Number : 8400097, Dearborn, United States
• Revive Research Institute - Lathrup Village- Site Number : 8400100, Lathrup Village, United States
• Romedica- Site Number : 8400043, Rochester, United States
• Great Lakes Research Institute Site Number : 8400111, Southfield, United States
• Great Lakes Research Institute - Southfield- Site Number : 8400111, Southfield, United States
• Allergy & Immunology Associates of Ann Arbor- Site Number : 8400107, Ypsilanti, United States
• The Asthma and Allergy Center- Site Number : 8400055, Bellevue, United States
• Jersey City Breathing Center: Elamir Mazhar- Site Number : 8400143, Jersey City, United States

And 199 other sites.