Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:10/25/2018
Start Date:April 27, 2015
End Date:November 23, 2017

Use our guide to learn which trials are right for you!

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent
asthma.

Secondary Objectives:

- To evaluate the safety and tolerability of dupilumab.

- To evaluate the effect of dupilumab on improving participant-reported outcomes including
health-related quality of life.

- To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

The total duration of study period for each participant is 67 to 69 weeks, including a
screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up
period of 12 weeks.

Inclusion criteria:

-Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months,
based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following
criteria:

a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate
twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone
propionate or equivalent) in combination with a second controller (eg, long-acting beta
agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month
prior to Visit 1.

i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of
fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS
must be ≥100 mcg of fluticasone propionate twice daily or equivalent).

ii) Participants requiring a third controller for their asthma will be considered eligible
for this study, and it should also be used for at least 3 months with a stable dose ≥1
month prior to Visit 1.

Exclusion criteria:

- Participants <12 years of age or the minimum legal age for adolescents in the country
of the investigative site, whichever is higher (For those countries where local
regulations permit enrollment of adults only, participant recruitment will be
restricted to those who are ≥18 years of age).

- Weight is less than 30 kilograms.

- Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary
fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.

- A participant who experiences a severe asthma exacerbation (defined as a deterioration
of asthma that results in emergency treatment, hospitalization due to asthma, or
treatment with systemic steroids at any time from 1 month prior to the Screening Visit
up to and including the Baseline Visit).

- Evidence of lung disease(s) other than asthma, either clinical evidence or imaging
(Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per
local standard of care.

- Note for Japan: According to the request from the health authority, chest X-ray should
be performed at screening visit if there is no chest imaging (Chest X-ray, computed
tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to
screening to exclude participants with suspected active or untreated latent
tuberculosis.

- Current smoker or cessation of smoking within 6 months prior to Visit 1.

- Previous smoker with a smoking history >10 pack-years.

- Comorbid disease that might interfere with the evaluation of Investigational Medicinal
Product.

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
We found this trial at
114
sites
?
mi
from
Plano, TX
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Bahía Blanca,
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boerne, TX
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Brandon, FL
Click here to add this to my saved trials
?
mi
from
Brick, NJ
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clackamas, OR
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
?
mi
from
Cypress, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Draper, UT
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Edmond, OK
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Flagstaff, AZ
Click here to add this to my saved trials
?
mi
from
Fort Mitchell, KY
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
?
mi
from
Gaithersburg, MD
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Jamaica, NY
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Killeen, TX
Click here to add this to my saved trials
?
mi
from
Lincoln, RI
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Live Oak, TX
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Loxahatchee Groves, Florida 33470
?
mi
from
Loxahatchee Groves, FL
Click here to add this to my saved trials
?
mi
from
McKinney, TX
Click here to add this to my saved trials
?
mi
from
Medford, OR
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mission Viejo, California 92691
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
?
mi
from
Missoula, MT
Click here to add this to my saved trials
?
mi
from
Murray, UT
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Ocean City, NJ
Click here to add this to my saved trials
?
mi
from
Ocoee, FL
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
?
mi
from
Papillion, NE
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
River Forest, IL
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rolling Hills Estates, California 90274
?
mi
from
Rolling Hills Estates, CA
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Jose, CA
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Savannah, GA
Click here to add this to my saved trials