Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 80
Updated:3/27/2019
Start Date:November 23, 2017
End Date:September 18, 2020
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to
Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe
Uncontrolled Asthma

This is a multicentre, randomized, double-blind, placebo controlled, parallel group study
designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with
severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma
controller medication with or without OCS. Approximately 1060 subjects will be randomized
globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous
injection at the study site, over a 52-week treatment period. The study also includes a
post-treatment follow-up period of 12 weeks.

Inclusion Criteria:

- Age. 12-80

- Documented physician-diagnosed asthma for at least 12 months

- Subjects who have received a physician-prescribed asthma controller medication with
medium or high dose ICS for at least 12 months.

- Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500
µg fluticasone propionate dry powder formulation equivalent total daily dose) for at
least 3 months.

- At least one additional maintenance asthma controller medication is required according
to standard practice of care and must be documented for at least 3 months.

- Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 yrs)

- Evidence of asthma as documented by either: Documented historical reversibility of
FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol)
reversibility of FEV1 ≥12% and ≥200 mL during screening.

- Documented history of at least 2 asthma exacerbation events within 12 months.

- ACQ-6 score ≥1.5 at screening and on day of randomization

Exclusion Criteria:

- Pulmonary disease other than asthma.

- History of cancer.

- History of a clinically significant infection.

- Current smokers or subjects with smoking history ≥10 pack-yrs.

- History of chronic alcohol or drug abuse within 12 months.

- Hepatitis B, C or HIV.

- Pregnant or breastfeeding.

- History of anaphylaxis following any biologic therapy.

- Subject randomized in the current study or previous tezepelumab studies.
We found this trial at
111
sites
?
mi
from
Warwick, RI
Click here to add this to my saved trials
?
mi
from
Allen, 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
Anderson, SC
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Auburn, AL
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Bayside, NY
Click here to add this to my saved trials
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
?
mi
from
Blue Ridge, GA
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Celebration, FL
Click here to add this to my saved trials
?
mi
from
Centennial, CO
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
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
?
mi
from
Cudahy, WI
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
Dothan, AL
Click here to add this to my saved trials
?
mi
from
Edmond, OK
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
?
mi
from
Fayetteville, GA
Click here to add this to my saved trials
?
mi
from
Flint, MI
Click here to add this to my saved trials
?
mi
from
Foley, AL
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 Wayne, IN
Click here to add this to my saved trials
?
mi
from
Gaffney, SC
Click here to add this to my saved trials
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
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
Hendersonville, North Carolina 28791
?
mi
from
Hendersonville, NC
Click here to add this to my saved trials
?
mi
from
Hendersonville, TN
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
Hollywood, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
?
mi
from
Kailua, HI
Click here to add this to my saved trials
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
?
mi
from
Lake Wales, FL
Click here to add this to my saved trials
?
mi
from
Lampasas, TX
Click here to add this to my saved trials
?
mi
from
Lansing, MI
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lathrup Village, Michigan 48076
?
mi
from
Lathrup Village, MI
Click here to add this to my saved trials
?
mi
from
Lenoir, NC
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
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
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Manassas, VA
Click here to add this to my saved trials
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
?
mi
from
Maumee, OH
Click here to add this to my saved trials
?
mi
from
Mayfield Heights, OH
Click here to add this to my saved trials
?
mi
from
McAllen, 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
Michigan City, IN
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
New Bern, NC
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 Windsor, NY
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
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Northfield, NJ
Click here to add this to my saved trials
?
mi
from
Northridge, CA
Click here to add this to my saved trials
?
mi
from
Novi, MI
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
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Oviedo, FL
Click here to add this to my saved trials
?
mi
from
Palm Desert, CA
Click here to add this to my saved trials
?
mi
from
Panama City, FL
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
?
mi
from
Port Huron, MI
Click here to add this to my saved trials
?
mi
from
Quincy, MA
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
Rolling Hills Estates, California 90274
?
mi
from
Rolling Hills Estates, CA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
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
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Savannah, GA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Sebring, FL
Click here to add this to my saved trials
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials