Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma (DIRECTION)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Biological: Experimental: Tezepelumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03927157

D5180C00021

Details and patient eligibility

About

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

Full 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 participants will be randomized regionally (China/non-China). Participants 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

Enrollment: 405 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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405 participants in 2 patient groups, including a placebo group

Tezepelumab

Experimental group

Description:

Tezepelumab: Tezepelumab subcutaneous injection

Treatment:

Biological: Experimental: Tezepelumab

Placebo

Placebo Comparator group

Description:

Placebo: Placebo subcutaneous injection

Treatment:

Other: Placebo