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Clinical Trials/NCT07363642
NCT07363642
Recruiting
Phase 3

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

AstraZeneca83 sites in 1 country400 target enrollmentStarted: January 28, 2026Last updated:
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InterventionsTezepelumab

Overview

Phase
Phase 3
Status
Recruiting
Enrollment
400
Locations
83
Primary Endpoint
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
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Detailed Description

This is a prospective, multi-center, single-arm Phase 3b study designed to evaluate the potential and safety of stepping down background maintenance therapy following the initiation of Tezepelumab treatment in Chinese patients with maintenance of asthma control.

This study will be conducted at approximately 70 study sites in China. The study duration for each patient will be up to 52 weeks. Approximately 400 patients with severe asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs or theophylline will be enrolled into this single arm study.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •1．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.
  • •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
  • •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
  • •If historical documentation is not available, reversibility must be demonstrated and documented at Visit
  • •4\. Documented current maintenance treatment with MD/HD ICS + LABA with up to one additional controller
  • •Other acceptable asthma controller includes LTRA, LAMA or theophylline
  • •On stable MD/HD ICS (\>250μg fluticasone propionate dry powder formulation equivalents total daily dose) + LABA stable for ≥2 months prior to enrollment
  • •On stable LTRA or LAMA or theophylline (≥2 weeks) is allowed

Exclusion Criteria

  • •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.

Arms & Interventions

Tezepelumab

Experimental

Severe asthma taking medium-high dose ICS/LABA with up to one additional controller will be enrolled into this single arm treatment

Intervention: Tezepelumab (Drug)

Outcomes

Primary Outcomes

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

Time Frame: within 36 weeks after the first administration

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

Secondary Outcomes

  • 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)
  • To assess the proportion of patients achieving improvement in patient reported outcomes measured by ACQ-5 score for Tezepelumab treated patients(From week0~week52)
  • To assess overall asthma exacerbation rate during the study of severe asthma patients treated with Tezepelumab(from week0~week52)
  • To assess biomarkers of severe asthma patients treated with Tezepelumab in the overall patient population(From week0~week52)
  • To assess the potential for Tezepelumab Treated participants to obtain fast symptom control measured by Daily Diary questionnaire(from week0~week2)
  • To assess the change from baseline in nasal symptoms in severe asthma patients with comorbid CRSwNP measured by Sinonasal outcome test-22 (SNOT-22) score treated with Tezepelumab(from week0~week48)
  • To assess the potential for Tezepelumab Treated participants to obtain fast symptom control measured by lung function measured by PEF measured by liters per minute improvement(from week0~week2)
  • To assess the proportion of patients achieving improvement in lung function measured by pulmonary function measured by pre-BD FEV1 measured in litres for Tezepelumab treated patients(From week0~week52)
  • To assess the proportion of patients achieving improvement in patient reported outcomes measured by SGRQ score for Tezepelumab treated patients(From week0~week52)
  • To assess the proportion of patients achieving improvement in patient reported outcomes measured by CET score for Tezepelumab treated patients(From week0~week52)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (83)

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