Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

  • STATUS
    Recruiting
  • participants needed
    396
  • sponsor
    AstraZeneca
Send
Updated on 16 February 2024
See if I qualify
fluticasone
albuterol
tezepelumab

Summary

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

Description

This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 396 subjects will be randomized regionally (China/non-China). 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.

Details
Condition Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma
Age 18years - 80years
Treatment Placebo, Experimental: Tezepelumab
Clinical Study IdentifierNCT03927157
SponsorAstraZeneca
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age. 18-80 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 6 months. Documented treatment with
a total daily dose of either medium or high dose ICS ( 500 g 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 Evidence of asthma
as documented by either: Documented historical reversibility of FEV1 12% and
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, and at least one of
the exacerbations should occur during the treatment of medium-to-high dose
ICS. 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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

fluticasone
albuterol
tezepelumab

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.