Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma
DIRECTION
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
1 other identifier
interventional
405
3 countries
72
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Jun 2019
Longer than P75 for phase_3 asthma
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 25, 2019
CompletedStudy Start
First participant enrolled
June 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2024
CompletedResults Posted
Study results publicly available
July 1, 2025
CompletedJuly 1, 2025
June 1, 2025
4.9 years
April 23, 2019
May 9, 2025
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annual Asthma Exacerbation Rate (AERR)
The annual exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks
Randomization to Week 52
Secondary Outcomes (18)
Mean Change From Baseline in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 52
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
Randomization to Week 52
Mean Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score at Week 52
Randomization to Week 52
Mean Change From Baseline in Weekly Mean Daily Asthma Symptom Diary Score at Week 52
Randomization to Week 52
Time to First Asthma Exacerbation
Randomization to Week 52
- +13 more secondary outcomes
Study Arms (2)
Tezepelumab
EXPERIMENTALTezepelumab: Tezepelumab subcutaneous injection
Placebo
PLACEBO COMPARATORPlacebo: Placebo subcutaneous injection
Interventions
Tezepelumab subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Amgencollaborator
Study Sites (72)
Research Site
Baotou, 14010, China
Research Site
Beijing, 1000096, China
Research Site
Beijing, 100020, China
Research Site
Beijing, 100029, China
Research Site
Beijing, 100070, China
Research Site
Beijing, 100730, China
Research Site
Beijing, 100853, China
Research Site
Changchun, 130021, China
Research Site
Changsha, 410008, China
Research Site
Changsha, 410011, China
Research Site
Chengdu, 610041, China
Research Site
Chongqing, 400000, China
Research Site
Chongqing, 400016, China
Research Site
Chongqing, 400038, China
Research Site
Fuzhou, 350001, China
Research Site
Guangzhou, 510080, China
Research Site
Guangzhou, 510120, China
Research Site
Guangzhou, 510515, China
Research Site
Guangzhou, China
Research Site
Guiyang, 550004, China
Research Site
Haikou, 570311, China
Research Site
Hangzhou, 310020, China
Research Site
Hefei, 133500, China
Research Site
Hengyang, 421001, China
Research Site
Hohhot, 010017, China
Research Site
Hohhot, 10050, China
Research Site
Huzhou, 313003, China
Research Site
Jinan, 250013, China
Research Site
Jinhua, 321000, China
Research Site
Kunming, 650032, China
Research Site
Lanzhou, 730000, China
Research Site
Linhai, 317000, China
Research Site
Linyi, CN-276003, China
Research Site
Nanchang, 330006, China
Research Site
Nanjing, 2100008, China
Research Site
Nanjing, 210009, China
Research Site
Nanjing, 210029, China
Research Site
Nanning, 530007, China
Research Site
Quanzhou, 362000, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200050, China
Research Site
Shengyang, 110004, China
Research Site
Shenyang, 110015, China
Research Site
Shenzhen, 518035, China
Research Site
Shijiazhuang, 050000, China
Research Site
Tianjin, 300192, China
Research Site
Ürümqi, 830054, China
Research Site
Weifang, 261041, China
Research Site
Wenzhou, 325027, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430030, China
Research Site
Wuhan, 430033, China
Research Site
Xi'an, 710004, China
Research Site
Xining, 810007, China
Research Site
Xuzhou, 221000, China
Research Site
Xuzhou, 221009, China
Research Site
Yangzhou, 225001, China
Research Site
Zhengzhou, 450000, China
Research Site
Zhuhai, 519099, China
Research Site
Zibo, 255036, China
Research Site
Zunyi, 563100, China
Research Site
Iloilo City, 5000, Philippines
Research Site
Quezon City, 1100, Philippines
Research Site
Cheongju-si, 28644, South Korea
Research Site
Daegu, 42415, South Korea
Research Site
Jeonju, 54907, South Korea
Research Site
Seoul, 03312, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Suwon, 16499, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Nanshan Zhong, Bachelor
Guangzhou institute of Respiratory Disease, China
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 25, 2019
Study Start
June 14, 2019
Primary Completion
May 24, 2024
Study Completion
August 13, 2024
Last Updated
July 1, 2025
Results First Posted
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.