A Randomized, Double-Blind, Placebo Controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients With Uncontrolled Moderate to Severe Asthma

Who is this study for? Adults with uncontrolled moderate to severe asthma
What treatments are being studied? Dupilumab
Status: Recruiting
Location: See all (245) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.

• Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for ≥12 months

• Treatment with medium to high dose inhaled corticosteroids (ICS) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), leukotriene receptor antagonists (LTRA) with a stable dose ≥1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be on stable dose ≥1 month prior to Visit 1. Patients requiring an additional controller as a fourth controller (Montelukast) for another type 2 comorbid condition such as allergic rhinitis will be considered eligible for this study, and should be on a stable dose for ≥1 month prior to Visit 1.

• Pre-bronchodilator forced expiratory volume (FEV1) ≤ 80% of predicted normal for adults at Visits 1 and 2, prior to randomization

• Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 and 2, prior to randomization.

• Variable airflow obstruction as documented by one or more of the following (at least 1 needs to be met):

• i) Positive reversibility test: ≥12% and 200 mL improvement in FEV1 after SABA administration prior to randomization, or documented in the 24 months prior to Visit 1. OR, ii) Positive bronchial challenge test: fall in FEV1 of ≥20% with standard doses of methacholine, or ≥15% with standardized hyperventilation, hypertonic saline or mannitol challenge prior to randomization or documented in the 24 months prior to Visit 1 OR, iii) Average daily diurnal Peak flow variability of \>10% over a 2-week period, documented in the past 24 months prior to Screening Visit 1. OR, iv) Airflow variability in clinic FEV1 \>12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Screening Visit 1. OR v) FEV1 increases by more than 12% and 200mL from baseline after 4 weeks of anti-inflammatory treatment.

• Reversibility test: Three attempts may be made during the Screening Period until the Baseline visit to meet the qualifying criteria for reversibility. This is only required if reversibility or other evidence of expiratory airflow limitation eligibility criteria was not performed within 24 months prior to Visit 1.

• FeNO ≥35 ppb at Visit 2, prior to randomization.

• History of ≥1 severe exacerbation(s) in the previous year before Visit1 defined as a deterioration of asthma requiring:

• i) Use of systemic corticosteroids for ≥3 days; or ii) Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.

Locations
United States
Alabama
Cullman Research Center- Site Number : 8400001
COMPLETED
Cullman
Shoals Primary Care - Sheffield- Site Number : 8400015
COMPLETED
Sheffield
Arizona
Chandler Clinical Research Trials- Site Number : 8400147
RECRUITING
Chandler
Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130
RECRUITING
Phoenix
Pulmonary Associates - Deer Valley Office- Site Number : 8400155
RECRUITING
Phoenix
Del Sol Research Management - Tucson- Site Number : 8400017
COMPLETED
Tucson
California
Kern Allergy and Medical Research- Site Number : 8400037
RECRUITING
Bakersfield
Vitality Clinical Research- Site Number : 8400142
ACTIVE_NOT_RECRUITING
Beverly Hills
Ascada Research - Fullerton- Site Number : 8400076
COMPLETED
Fullerton
Allergy and Asthma Specialists Medical Group- Site Number : 8400162
RECRUITING
Huntington Beach
Newport Native MD- Site Number : 8400054
RECRUITING
Newport Beach
Prospective Research Innovations- Site Number : 8400131
RECRUITING
Rancho Cucamonga
Mercy Medical Group - Midtown- Site Number : 8400164
RECRUITING
Sacramento
Integrated Research of Inland- Site Number : 8400156
RECRUITING
Upland
Allianz Research Institute- Site Number : 8400018
ACTIVE_NOT_RECRUITING
Westminster
Woodland Clinic - Woodland- Site Number : 8400171
RECRUITING
Woodland
Florida
Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035
COMPLETED
Altamonte Springs
Florida Center for Allergy & Asthma Research- Site Number : 8400032
RECRUITING
Aventura
Beautiful Minds Clinical Research Center- Site Number : 8400141
RECRUITING
Cutler Bay
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023
COMPLETED
Debary
Florida Lung, Asthma and Sleep Specialists (FLASS) - Polynesian- Site Number : 8400098
RECRUITING
Kissimmee
Ivetmar Medical Group- Site Number : 8400063
RECRUITING
Miami
My Preferred Research- Site Number : 8400073
RECRUITING
Miami
Research Institute of South Florida- Site Number : 8400079
RECRUITING
Miami
Floridian Clinical Research - Miami Lakes- Site Number : 8400091
RECRUITING
Miami Lakes
Heuer M.D. Research- Site Number : 8400024
RECRUITING
Orlando
JSV Clinical Research- Site Number : 8400150
COMPLETED
Tampa
Georgia
Appalachian Clinical Research- Site Number : 8400129
RECRUITING
Adairsville
Alpha Clinical Research Group - Dunwoody- Site Number : 8400116
RECRUITING
Dunwoody
Aeroallergy Research Laboratory- Site Number : 8400114
RECRUITING
Savannah
Illinois
Rush University Medical Center- Site Number : 8400146
RECRUITING
Chicago
NorthShore University HealthSystem - Skokie- Site Number : 8400138
RECRUITING
Skokie
Kentucky
Family Allergy & Asthma - Louisville - Goss Avenue- Site Number : 8400160
RECRUITING
Louisville
Allergy and Asthma Specialist- Site Number : 8400007
RECRUITING
Owensboro
Louisiana
Avant Research Associates - Crowley- Site Number : 8400117
COMPLETED
Crowley
Tandem Clinical Research - Metairie- Site Number : 8400163
RECRUITING
Metairie
Massachusetts
Genesis Clinical Research - Fall River- Site Number : 8400050
RECRUITING
Fall River
Maryland
Javara - Privia Medical Group - Annapolis- Site Number : 8400087
RECRUITING
Annapolis
Kur Research - Columbia Medical- Site Number : 8400169
RECRUITING
Columbia
Chesapeake Clinical Research - White Marsh- Site Number : 8400119
COMPLETED
White Marsh
Michigan
University of Michigan Health System - Ann Arbor- Site Number : 8400030
RECRUITING
Ann Arbor
Revival Research Institute - Dearborn- Site Number : 8400097
RECRUITING
Dearborn
Revive Research Institute - Lathrup Village- Site Number : 8400100
RECRUITING
Lathrup Village
Romedica- Site Number : 8400043
COMPLETED
Rochester
Great Lakes Research Institute - Southfield- Site Number : 8400111
RECRUITING
Southfield
Great Lakes Research Institute Site Number : 8400111
RECRUITING
Southfield
Allergy & Immunology Associates of Ann Arbor- Site Number : 8400107
RECRUITING
Ypsilanti
North Carolina
Clinical Research Of Gastonia- Site Number : 8400012
RECRUITING
Gastonia
Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400056
RECRUITING
Huntersville
Lapis Clinical Research - Mooresville- Site Number : 8400112
COMPLETED
Mooresville
Southeastern Research Center- Site Number : 8400153
RECRUITING
Winston-salem
Nebraska
The Asthma and Allergy Center- Site Number : 8400055
RECRUITING
Bellevue
New Jersey
Jersey City Breathing Center: Elamir Mazhar- Site Number : 8400143
RECRUITING
Jersey City
New York
Urban Health Plan- Site Number : 8400144
RECRUITING
The Bronx
Ohio
Asthma & Allergy Center - Toledo- Site Number : 8400051
RECRUITING
Toledo
Pennsylvania
St. Luke's University Hospital- Site Number : 8400099
RECRUITING
Bethlehem
Temple University Hospital- Site Number : 8400038
RECRUITING
Philadelphia
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400042
RECRUITING
Pittsburgh
South Carolina
Bogan Sleep Consultants- Site Number : 8400102
RECRUITING
Columbia
ADAC Research, PA- Site Number : 8400026
RECRUITING
Greenville
Main Street Physician's Care- Site Number : 8400077
COMPLETED
Little River
National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400092
RECRUITING
North Charleston
South Dakota
Health Concepts- Site Number : 8400006
RECRUITING
Rapid City
Texas
REX Clinical Trials - Beaumont- Site Number : 8400135
RECRUITING
Beaumont
South Texas Medical Research Institute - TTS Research- Site Number : 8400009
RECRUITING
Boerne
Discovery Clinical Trials - Dallas- Site Number : 8400123
COMPLETED
Dallas
IntraCare- Site Number : 8400003
RECRUITING
Dallas
C & R Research Services - Houston- Site Number : 8400067
RECRUITING
Houston
Clear Brook Medical Associates- Site Number : 8400080
COMPLETED
Houston
Metroplex Pulmonary and Sleep Center- Site Number : 8400014
RECRUITING
Mckinney
Andante Research- Site Number : 8400140
RECRUITING
San Antonio
DM Clinical Research - 710 Lawrence Street- Site Number : 8400103
RECRUITING
Tomball
Virginia
Burke Internal Medicine and Research- Site Number : 8400170
RECRUITING
Burke
University of Virginia- Site Number : 8400082
RECRUITING
Charlottesville
Other Locations
Belgium
Investigational Site Number : 0560002
RECRUITING
Brussels
Investigational Site Number : 0560003
RECRUITING
Liège
Brazil
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760006
RECRUITING
Belo Horizonte
Hospital Dia do Pulmão- Site Number : 0760002
RECRUITING
Blumenau
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760005
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760003
RECRUITING
Porto Alegre
Associacao Proar- Site Number : 0760004
RECRUITING
Salvador
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760007
RECRUITING
São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
RECRUITING
São Paulo
Clinica de Alergia Martti Antila- Site Number : 0760009
RECRUITING
Sorocaba
Bulgaria
Investigational Site Number : 1000005
RECRUITING
Dupnitsa
Investigational Site Number : 1000012
RECRUITING
Plovdiv
Investigational Site Number : 1000011
RECRUITING
Rousse
Investigational Site Number : 1000002
RECRUITING
Sofia
Investigational Site Number : 1000008
RECRUITING
Sofia
Investigational Site Number : 1000009
RECRUITING
Sofia
Investigational Site Number : 1000014
RECRUITING
Sofia
Investigational Site Number : 1000013
RECRUITING
Vratsa
Canada
Investigational Site Number : 1240015
RECRUITING
Ajax
Investigational Site Number : 1240028
RECRUITING
Calgary
Investigational Site Number : 1240020
RECRUITING
Kelowna
Investigational Site Number : 1240010
RECRUITING
Moncton
Investigational Site Number : 1240014
COMPLETED
Montreal
Investigational Site Number : 1240017
RECRUITING
Montreal
Investigational Site Number : 1240023
RECRUITING
Montreal
Investigational Site Number : 1240018
RECRUITING
Niagara Falls
Investigational Site Number : 1240002
RECRUITING
Québec
Investigational Site Number : 1240024
RECRUITING
Saskatoon
Investigational Site Number : 1240025
RECRUITING
Sherbrooke
Investigational Site Number : 1240001
RECRUITING
Toronto
Investigational Site Number : 1240007
RECRUITING
Toronto
Investigational Site Number : 1240011
RECRUITING
Toronto
Investigational Site Number : 1240004
RECRUITING
Vancouver
Investigational Site Number : 1240022
RECRUITING
Vancouver
Investigational Site Number : 1240003
RECRUITING
Windsor
China
Investigational Site Number : 1560017
RECRUITING
Beijing
Investigational Site Number : 1560022
RECRUITING
Beijing
Investigational Site Number : 1560030
RECRUITING
Beijing
Investigational Site Number : 1560024
RECRUITING
Bengbu
Investigational Site Number : 1560006
RECRUITING
Dongguan
Investigational Site Number : 1560007
RECRUITING
Guangzhou
Investigational Site Number : 1560019
RECRUITING
Guiyang
Investigational Site Number : 1560003
RECRUITING
Hebei
Investigational Site Number : 1560023
RECRUITING
Hefei
Investigational Site Number : 1560029
RECRUITING
Luzhou
Investigational Site Number : 1560002
RECRUITING
Nanchang
Investigational Site Number : 1560014
RECRUITING
Nanjing
Investigational Site Number : 1560008
RECRUITING
Ningbo
Investigational Site Number : 1560031
RECRUITING
Ningbo
Investigational Site Number : 1560001
RECRUITING
Shanghai
Investigational Site Number : 1560011
RECRUITING
Taiyuan
Investigational Site Number : 1560012
RECRUITING
Taiyuan
Investigational Site Number : 1560004
RECRUITING
Tianjin
Investigational Site Number : 1560025
RECRUITING
Tianjin
Investigational Site Number : 1560009
RECRUITING
Wuxi
Investigational Site Number : 1560028
RECRUITING
Xi'an
Investigational Site Number : 1560020
RECRUITING
Xiamen
Investigational Site Number : 1560013
RECRUITING
Yichang
Investigational Site Number : 1560010
RECRUITING
Yueyang
Investigational Site Number : 1560021
RECRUITING
Zhengzhou
Greece
Investigational Site Number : 3000003
RECRUITING
Athens
Investigational Site Number : 3000004
RECRUITING
Athens
Investigational Site Number : 3000005
RECRUITING
Athens
Investigational Site Number : 3000006
RECRUITING
Athens
Investigational Site Number : 3000007
RECRUITING
Athens
Investigational Site Number : 3000010
RECRUITING
Athens
Investigational Site Number : 3000002
RECRUITING
Ioannina
Investigational Site Number : 3000009
RECRUITING
Palaió Fáliro
Investigational Site Number : 3000001
RECRUITING
Thessaloniki
Investigational Site Number : 3000008
RECRUITING
Thessaloniki
Hungary
Investigational Site Number : 3480011
RECRUITING
Budapest
Investigational Site Number : 3480012
RECRUITING
Budapest
Investigational Site Number : 3480008
ACTIVE_NOT_RECRUITING
Debrecen
Investigational Site Number : 3480005
RECRUITING
Edelény
Investigational Site Number : 3480004
RECRUITING
Hajdúnánás
Investigational Site Number : 3480007
RECRUITING
Mosonmagyaróvár
Investigational Site Number : 3480003
RECRUITING
Püspökladány
Investigational Site Number : 3480001
RECRUITING
Százhalombatta
Investigational Site Number : 3480013
RECRUITING
Szekszárd
Investigational Site Number : 3480006
RECRUITING
Szombathely
India
Investigational Site Number : 3560011
RECRUITING
Ahmedabad
Investigational Site Number : 3560003
RECRUITING
Chandigarh
Investigational Site Number : 3560008
RECRUITING
Coimbatore
Investigational Site Number : 3560016
RECRUITING
Faridabad
Investigational Site Number : 3560001
RECRUITING
Jaipur
Investigational Site Number : 3560019
RECRUITING
Jodhpur
Investigational Site Number : 3560002
RECRUITING
Kozhikode
Investigational Site Number : 3560014
RECRUITING
Lucknow
Investigational Site Number : 3560006
RECRUITING
Mangaluru
Investigational Site Number : 3560018
RECRUITING
Mysuru
Investigational Site Number : 3560009
RECRUITING
Nagpur
Investigational Site Number : 3560012
RECRUITING
Nagpur
Investigational Site Number : 3560015
RECRUITING
New Delhi
Investigational Site Number : 3560020
RECRUITING
Pune
Investigational Site Number : 3560004
RECRUITING
Vadodara
Ireland
Investigational Site Number : 3720001
RECRUITING
Cork
Investigational Site Number : 3720003
RECRUITING
Dublin
Mexico
Investigational Site Number : 4840012
RECRUITING
Chihuahua City
Investigational Site Number : 4840016
RECRUITING
Chihuahua City
Investigational Site Number : 4840001
RECRUITING
Durango
Investigational Site Number : 4840002
RECRUITING
Guadalajara
Investigational Site Number : 4840006
RECRUITING
Mexico City
Investigational Site Number : 4840005
RECRUITING
Monterrey
Investigational Site Number : 4840008
RECRUITING
Monterrey
Investigational Site Number : 4840013
RECRUITING
Oaxaca City
Investigational Site Number : 4840014
RECRUITING
San Juan Del Río
Investigational Site Number : 4840003
RECRUITING
Veracruz
Investigational Site Number : 4840010
RECRUITING
Villahermosa
Oman
Investigational Site Number : 5120001
RECRUITING
Muscat
Investigational Site Number : 5120002
RECRUITING
Muscat
Peru
Investigational Site Number : 6040001
RECRUITING
Lima
Investigational Site Number : 6040002
RECRUITING
Lima
Investigational Site Number : 6040003
RECRUITING
Piura
Puerto Rico
Cardio Pulmonary Research Center- Site Number : 8400126
RECRUITING
Guaynabo
FDI Clinical Research- Site Number : 8400121
RECRUITING
San Juan
University of Puerto Rico - Medical Sciences Campus- Site Number : 8400128
RECRUITING
San Juan
Republic of Korea
Investigational Site Number : 4100010
RECRUITING
Bupyeong-gu
Investigational Site Number : 4100007
RECRUITING
Busan
Investigational Site Number : 4100006
RECRUITING
Daegu
Investigational Site Number : 4100001
RECRUITING
Seoul
Investigational Site Number : 4100002
RECRUITING
Seoul
Investigational Site Number : 4100003
RECRUITING
Seoul
Investigational Site Number : 4100004
RECRUITING
Seoul
Investigational Site Number : 4100005
RECRUITING
Seoul
Investigational Site Number : 4100009
RECRUITING
Seoul
Investigational Site Number : 4100008
RECRUITING
Wŏnju
Romania
Investigational Site Number : 6420010
RECRUITING
Baia Mare
Investigational Site Number : 6420005
RECRUITING
Bragadiru
Investigational Site Number : 6420002
RECRUITING
Brasov
Investigational Site Number : 6420007
RECRUITING
Brasov
Investigational Site Number : 6420004
RECRUITING
Codlea
Investigational Site Number : 6420011
RECRUITING
Craiova
Investigational Site Number : 6420001
RECRUITING
Deva
Investigational Site Number : 6420008
RECRUITING
Piteşti
Investigational Site Number : 6420009
RECRUITING
Timișoara
Saudi Arabia
Investigational Site Number : 6820008
RECRUITING
Makkah Al Mukarramah
Slovakia
Investigational Site Number : 7030003
RECRUITING
Levice
Investigational Site Number : 7030001
RECRUITING
Poprad
Investigational Site Number : 7030002
RECRUITING
Spišská Nová Ves
Investigational Site Number : 7030005
RECRUITING
Topoľčany
South Africa
Investigational Site Number : 7100006
RECRUITING
Benoni
Investigational Site Number : 7100001
RECRUITING
Cape Town
Investigational Site Number : 7100004
RECRUITING
Cape Town
Investigational Site Number : 7100013
RECRUITING
Cape Town
Investigational Site Number : 7100012
RECRUITING
Chatsworth
Investigational Site Number : 7100003
RECRUITING
Durban
Investigational Site Number : 7100009
RECRUITING
Durban
Investigational Site Number : 7100014
RECRUITING
Johannesburg
Investigational Site Number : 7100002
RECRUITING
Pretoria
Investigational Site Number : 7100008
RECRUITING
Somerset West
Investigational Site Number : 7100007
RECRUITING
Vereeniging
Taiwan
Investigational Site Number : 1580003
RECRUITING
Douliu
Investigational Site Number : 1580001
RECRUITING
Kaohsiung City
Investigational Site Number : 1580004
RECRUITING
Taichung
Investigational Site Number : 1580002
RECRUITING
Taipei
Turkey
Investigational Site Number : 7920007
RECRUITING
Ankara
Investigational Site Number : 7920008
COMPLETED
Ankara
Investigational Site Number : 7920003
ACTIVE_NOT_RECRUITING
Balcali Adana
Investigational Site Number : 7920001
RECRUITING
Istanbul
Investigational Site Number : 7920006
RECRUITING
Izmir
Investigational Site Number : 7920009
RECRUITING
Kayseri
Investigational Site Number : 7920004
RECRUITING
Kırıkkale
Investigational Site Number : 7920002
ACTIVE_NOT_RECRUITING
Mersin
United Arab Emirates
Investigational Site Number : 7840001
RECRUITING
Abu Dhabi
Investigational Site Number : 7840002
RECRUITING
Abu Dhabi
United Kingdom
Investigational Site Number : 8260002
RECRUITING
Bradford
Investigational Site Number : 8260004
RECRUITING
Cambridge
Investigational Site Number : 8260005
RECRUITING
Liverpool
Investigational Site Number : 8260001
RECRUITING
Newcastle Upon Tyne
Investigational Site Number : 8260003
RECRUITING
Oxford
Investigational Site Number : 8260008
RECRUITING
Wakefield
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2021-12-16
Estimated Completion Date: 2030-01-22
Participants
Target number of participants: 1324
Treatments
Experimental: Dupilumab
Dupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1
Placebo_comparator: Placebo
Matching placebo administered Q2W after an initial loading dose (2 injections) on Day 1
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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