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Study Complete
Sponsor ID
D5180C00021

Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled AsthmaDIRECTION

Sponsor ID
D5180C00021
Clinicaltrials.gov ID
NCT03927157
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
405
Additional Study Details

Protocol Summary

Primary Outcome Measures

Annual Asthma Exacerbation Rate (AERR)

Timeframe: Randomization to Week 52

Secondary Outcome Measures

Mean Change From Baseline in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 52

Timeframe: Randomization to Week 52

Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score at Week 52

Timeframe: Randomization to Week 52

Mean Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score at Week 52

Timeframe: Randomization to Week 52

Mean Change From Baseline in Weekly Mean Daily Asthma Symptom Diary Score at Week 52

Timeframe: Randomization to Week 52

Time to First Asthma Exacerbation

Timeframe: Randomization to Week 52

Mean Change From Baseline in Fractional Exhaled Nitric Oxide at Week 52

Timeframe: Randomization to Week 52

Number of Participants With Asthma Specific Resource Utilization Over 52 Weeks

Timeframe: Randomization to Week 52

Pharmacokinetics of Tezepelumab

Timeframe: Baseline, Week 24, Week 52, Week 64

Mean Change From Baseline in EQ-5D-5L VAS Score at Week 52

Timeframe: At Week 52

Mean Change From Baseline in Blood Eosinophils (Cells/uL) at Week 52

Timeframe: Randomization to Week 52

Mean Change From Baseline in Total Serum IgE (IU/mL) at Week 52

Timeframe: Randomization to Week 52

Mean Change From Baseline in Night Time Awakenings (Percentage) at Week 52

Timeframe: Randomization to Week 52

Immunogenicity of Tezepelumab

Timeframe: Baseline to Week 64

Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52

Timeframe: Randomization to Week 52

Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52

Timeframe: Randomization to Week 52

Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52

Timeframe: Randomization to Week 52

Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalization

Timeframe: Randomization to Week 52

Proportion of Participants Who Had no Asthma Exacerbations

Timeframe: Randomization to Week 52

Study Documents

Protocol
Available Language(s): English
Download Document(s)
Statistical Analysis Plan
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Baotou, China, 14010
Status
N/A
Location
Research Site
Beijing, China, 1000096
Status
N/A
Location
Research Site
Beijing, China, 100020
Status
N/A
Location
Research Site
Beijing, China, 100029
Status
N/A
Location
Research Site
Beijing, China, 100070
Status
N/A
Location
Research Site
Beijing, China, 100730
Status
N/A
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Study Info
Age
18 - 80 Years
Condition
  • Asthma
    • Sex
    All
    Trial Dates
    Jun 2019 - May 2024
    Inclusion and Exclusion 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.