Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
TAPER
TAPER: A Prospective, Interventional, Multicentre, Single-Arm, Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Asthma Treated With Tezepelumab
1 other identifier
interventional
400
1 country
76
Brief Summary
This study aims to explore the potential for Tezepelumab-treated severe asthmatic patients to effectively and safely reduce their background maintenance medication while maintaining asthma symptom control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2026
Typical duration for phase_3
76 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
November 25, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
January 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
May 26, 2026
May 1, 2026
1.5 years
November 25, 2025
May 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess the potential for Tezepelumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population while maintaining asthma control
Main Endpoints: Proportion of patients with at least one controller medication category reduction at the end of reduction phase (week 36) while sustaining asthma control * discontinuation of LTRA, or * discontinuation of LAMA, or * discontinuation of theophylline, or * Reduce inhale therapy to MD ICS/LABA, or * Reduce inhale therapy to LD ICS/LABA
within 36 weeks after the first administration
To assess the potential for Tezepelumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population while maintaining asthma control
Supportive outcomes: * Proportion of patients with individual category reduction at end of reduction phase * Proportion of patients with ≥2 category reductions in controller medication
within 36 weeks after the first administration
Secondary Outcomes (18)
To assess standard asthma efficacy measures for Tezepelumab treated patients for pulmonary function measured by pre-BD FEV1
From week0~week48
To assess standard asthma efficacy measures for Tezepelumab treated patients for asthma symptoms control measured by Asthma Control Questionnaire-5(ACQ-5) score
From week0~week48
To assess standard asthma efficacy measures for Tezepelumab treated patients for asthma symptoms control measured by St. George's Respiratory Questionnaire (SGRQ) score
From week0~week48
To assess standard asthma efficacy measures for Tezepelumab treated patients for asthma symptoms control measured by Cough Evaluation Test (CET) score
From week0~week48
To assess if reductions in background therapies achieved at the end of reduction phase are maintained until the end of maintenance phase
From week36~week48
- +13 more secondary outcomes
Study Arms (1)
Tezepelumab
EXPERIMENTALSevere asthma taking medium-high dose ICS/LABA with up to one additional controller will be enrolled into this single arm treatment
Interventions
Severe asthma taking medium-high dose ICS/LABA with up to one additional controller will be enrolled into this single arm treatment
Eligibility Criteria
You may qualify if:
- ．Provision of informed consent prior to any study-specific procedures. Written informed consent, and assent when applicable for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent\[s\]/guardian\[s\]) and according to international guidelines and/or applicable local guidelines.
- Age 2. Patient must be aged 12-80 years old, inclusively, at the time of Visit 1(Week -1 to Week 0) For those patients, who are 17 on the day of Visit 1(Week -1 to Week 0) but will turn 18 after this day, will be considered an adolescent for the purposes of this study.
- Type of Patient and Disease Characteristics 3. Documented history of physician-diagnosed asthma prior to Visit 1
- Documented post-bronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1, or FEV1≥400 mL variability over time, or positive result of branchial provocation test within 12 months prior to Visit 1. If historical documentation is not available, reversibility must be demonstrated and documented at Visit 1.
- \. Documented current maintenance treatment with MD/HD ICS + LABA with up to one additional controller
- Other acceptable asthma controller includes LTRA, LAMA or theophylline 5. On stable MD/HD ICS (\>250μg fluticasone propionate dry powder formulation equivalents total daily dose) + LABA stable for ≥2 months prior to enrollment 6. On stable LTRA or LAMA or theophylline (≥2 weeks) is allowed 7. Documented ACQ-5 ≥ 1.5 in Visit 1 8. Documented at least one exacerbation in the year prior to enrolment
- A qualifying historical asthma exacerbation is a symptomatic worsening requiring systemic corticosteroid (i.e., oral, intravenous (IV) or intramuscular; any healthcare setting or temporary increase from a stable maintenance dose of oral corticosteroid) or that resulted in hospitalization or emergency room/urgent care visit.
- Examples of acceptable documentation of the asthma disease state and prior asthma exacerbations include clinic visit (primary or specialist Health care provider (HCP)), emergency room/urgent care, or hospital records listing asthma as a current problem, plus documentation of at least 1 asthma exacerbations during the 12 months prior to ICF.
- Weight 9. Weight of ≥40 kg at Visit 1. Sex and Contraceptive/Barrier Requirements 10. Male and/or female Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female patients:
- Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Females will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to Visit 1(Week -1 to Week 0) without an alternative medical cause. The following age-specific requirements apply:
- Females \< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range.
- Females ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
- Female patients of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Females of childbearing potential who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 8 weeks after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician.
- The following are not acceptable methods of contraception: periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea. Female condom and male condom should not be used together.
- +2 more criteria
You may not qualify if:
- Medical Conditions
- Unable to commit to the scheduled visits as required by the protocol, or unable to commit to undergoing protocol guided reductions in asthma therapy, as directed by the Investigator.
- Clinically important pulmonary disease other than asthma (e.g., active lung infection, chronic obstructive pulmonary disease \[COPD\], bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that is associated with elevated peripheral eosinophil counts (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
- Within the 12 months prior to Visit 1, a CT scan is required to exclude related diseases.
- Current smokers at Visit 1 are not allowed. Former smokers with smoking history ≥ 10 pack-years at Visit 1 are not allowed; Former smokers with a smoking history of \<10 pack years must have stopped for at least 6 months to be eligible.
- History of alcohol or drug abuse within 12 months prior to Visit 1(Week -1 to Week 0).
- A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1(Week -1 to Week 0) that has not been treated with, or has failed to respond to, standard of care therapy.
- History of anaphylaxis to any biologic therapy.
- Known history of allergy or reaction to any component of the study treatment formulation.
- Respiratory exacerbation requiring use of Systemic corticosteroids (SCS) or acute upper/lower respiratory infection that required antibiotics or antiviral medication within 30 days prior to Visit 1(Week -1 to Week 0). An extension of the screening period up to 3 months is allowed to ensure that a patient recovering from any repiratory exacerbation or acute upper/lower respiratory infection can be included.
- A history of known immunodeficiency disorder, including human immunodeficiency virus.
- Current or history of malignancy within 5 years before the screening visit with the following exceptions:
- In-situ carcinoma of the cervix where curative therapy has been completed and patients are in remission for at least 12 months prior to screening.
- Basal cell or superficial squamous skin cancer.
- Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (76)
Research Site
Beijing, 100020, China
Research Site
Beijing, 100191, China
Research Site
Beijing, 100730, China
Research Site
Beijing, 100730, China
Research Site
Beijing, 102300, China
Research Site
Beijing, 10730, China
Research Site
Beijing, 211405, China
Research Site
Binzhou, 256606, China
Research Site
Changsha, 410008, China
Research Site
Changsha, 430033, China
Research Site
Chengdu, 610041, China
Research Site
Chengdu, 610072, China
Research Site
Chengdu, 610095, China
Research Site
Chengdu, 610500, China
Research Site
Chongqing, 400042, China
Research Site
Chongqing, 400072, China
Research Site
Deyang, 618000, China
Research Site
Fuzhou, 350001, China
Research Site
Guangzhou, 510080, China
Research Site
Guangzhou, 510100, China
Research Site
Guangzhou, 510163, China
Research Site
Guangzhou, 510180, China
Research Site
Guangzhou, 510280, China
Research Site
Guangzhou, 510515, China
Research Site
Guangzhou, 510620, China
Research Site
Guiyang, 510630, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310006, China
Research Site
Hangzhou, 310016, China
Research Site
Hefei, 230061, China
Research Site
Hefei, 230601, China
Research Site
Hohhot, 010017, China
Research Site
Jiangmen, 529000, China
Research Site
Jinan, 250012, China
Research Site
Jinan, 250014, China
Research Site
Jinan, 250021, China
Research Site
Jining, 272006, China
Research Site
Kunming, 650032, China
Research Site
Leshan, 614000, China
Research Site
Linyi, CN-276003, China
Research Site
Luzhou, 646000, China
Research Site
Meizhou, 514700, China
Research Site
Mianyang, 621000, China
Research Site
Nanchang, 330006, China
Research Site
Nanjing, 210029, China
Research Site
Nanjing, 211100, China
Research Site
Nanning, 530000, China
Research Site
Ningbo, 315010, China
Research Site
Quanzhou, 362000, China
Research Site
Shanghai, 200000, China
Research Site
Shanghai, 200003, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200433, China
Research Site
Shanghai, 310000, China
Research Site
Shantou, 515041, China
Research Site
Shenyang, 110001, China
Research Site
Shenzhen, 518020, China
Research Site
Shenzhen, 518036, China
Research Site
Shijiazhuang, 054001, China
Research Site
Suining Shi, 629000, China
Research Site
Suzhou, 215006, China
Research Site
Taiyuan, 030001, China
Research Site
Taiyuan, 030032, China
Research Site
Tianjin, 300192, China
Research Site
Weifang, 261000, China
Research Site
Wenzhou, 325027, China
Research Site
Wuhan, 430030, China
Research Site
Wuhan, 430060, China
Research Site
Wuxi, 214023, China
Research Site
Xi'an, 710061, China
Research Site
Zhangzhou, 363099, China
Research Site
Zhanjiang, 524004, China
Research Site
Zhengzhou, 450003, China
Research Site
Zhengzhou, 450007, China
Research Site
Zhongshan, 528403, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KeFang Lai, Professor
The First Affiliated Hospital of Guangzhou Medical University
- PRINCIPAL INVESTIGATOR
FengMing Luo, Professor
Sichuan University West China Hospital
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2025
First Posted
January 23, 2026
Study Start
January 28, 2026
Primary Completion (Estimated)
August 7, 2027
Study Completion (Estimated)
March 31, 2029
Last Updated
May 26, 2026
Record last verified: 2026-05
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 PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, it indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.