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

  • End date
    Aug 19, 2024
  • participants needed
  • sponsor
Updated on 5 May 2022


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


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.

Condition Asthma
Treatment Placebo, Experimental: Tezepelumab
Clinical Study IdentifierNCT03927157
Last Modified on5 May 2022


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 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 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
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