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Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Asthma

Interventions: Experimental: Tezepelumab, Placebo

Countries: China, Philippines, South Korea

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

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age. 18-80
* Documented physician-diagnosed asthma for at least 12 months
* Participants 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 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
* 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, 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 participants 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.
* participant randomized in the current study or previous tezepelumab studies.

Locations (72)

Baotou, China
Beijing, China
Beijing, China
Beijing, China
Beijing, China
Beijing, China
Beijing, China
Changchun, China
Changsha, China
Changsha, China
Chengdu, China
Chongqing, China
Chongqing, China
Chongqing, China
Fuzhou, China
Guangzhou, China
Guangzhou, China
Guangzhou, China
Guangzhou, China
Guiyang, China
Haikou, China
Hangzhou, China
Hefei, China
Hengyang, China
Hohhot, China
Hohhot, China
Huzhou, China
Jinan, China
Jinhua, China
Kunming, China
+ 42 more on CT.gov