STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma (STEP)

September 2, 2026 updated by: AstraZeneca

STEP: A Prospective, Interventional, Multicenter, Single-Arm Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

This is a prospective, multi-center, single-arm Phase 3b study designed to evaluate the potential benefit to patients if benralizumab treatment could enable reduction in asthma maintenance controllers while allowing patients to maintain asthma control in Chinese patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study population will be approximately 440-520 patients on MD/HD ICS/LABA with and without LTRA or LAMA or theophylline and meeting study inclusion and exclusion criteria in China. After patients sign the informed consent, they will undergo a screening visit (Visit 1, Week -1 to Week 0) to assess eligibility criteria. Patients who meet eligibility criteria and complete study baseline assessments will enter the study and receive the first dose of benralizumab at visit 2 (Week 0).

The benralizumab treatment includes 4 phases: Induction Phase (16 weeks), Reduction Phase (24 weeks), Maintenance Phase (16 weeks) and Follow-up Phase (4 weeks). After initiation of benralizumab 30 mg administered subcutaneously every 4 weeks (Q4W) for the first 3 doses (Visits 2 to 4), then every 8 weeks (Q8W) thereafter.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
504

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100020
        • Research Site
      • Beijing, China, 100730
        • Research Site
      • Beijing, China, 100029
        • Research Site
      • Beijing, China, 100191
        • Research Site
      • Changsha, China, 410011
        • Research Site
      • Changsha, China, 410008
        • Research Site
      • Changsha, China, 410005
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Chengdu, China, 610072
        • Research Site
      • Chengdu, China, 610014
        • Research Site
      • Chengdu, China, 610021
        • Research Site
      • Chongqing, China, 402260
        • Research Site
      • Guangzhou, China, 510515
        • Research Site
      • Guangzhou, China, 510630
        • Research Site
      • Guangzhou, China, 510280
        • Research Site
      • Guangzhou, China, 510163
        • Research Site
      • Guilin, China, 541001
        • Research Site
      • Guiyang, China, 510630
        • Research Site
      • Hangzhou, China, 310006
        • Research Site
      • Hangzhou, China, 310009
        • Research Site
      • Hefei, China, 230601
        • Research Site
      • Hefei, China, 230061
        • Research Site
      • Hohhot, China, 10050
        • Research Site
      • Hohhot, China, 010010
        • Research Site
      • Huzhou, China, 313003
        • Research Site
      • Jinan, China, 250012
        • Research Site
      • Jinan, China, 250014
        • Research Site
      • Jinan, China, 250030
        • Research Site
      • Kunming, China, CN-650034
        • Research Site
      • Lanzhou, China, 730000
        • Research Site
      • Luoyang, China, 471000
        • Research Site
      • Nanjing, China, 211100
        • Research Site
      • Nanjing, China, 210029
        • Research Site
      • Nanning, China, 530021
        • Research Site
      • Ningbo, China, 315010
        • Research Site
      • Qingdao, China, 266042
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200080
        • Research Site
      • Shanghai, China, 200025
        • Research Site
      • Shanghai, China, 200065
        • Research Site
      • Shanghai, China, 200092
        • Research Site
      • Shenyang, China, 110001
        • Research Site
      • Shenyang, China, 110004
        • Research Site
      • Shenzhen, China, 518039
        • Research Site
      • Shenzhen, China, 518036
        • Research Site
      • Shenzhen, China, 518101
        • Research Site
      • Shenzhen, China, 518001
        • Research Site
      • Shijiazhuang, China, 50051
        • Research Site
      • Shijiazhuang, China, 054001
        • Research Site
      • Suzhou, China, 215004
        • Research Site
      • Suzhou, China, 215006
        • Research Site
      • Taiyuan, China, 030001
        • Research Site
      • Taiyuan, China, 030032
        • Research Site
      • Tangshan, China, 63000
        • Research Site
      • Tianjin, China, 300192
        • Research Site
      • Tianjin, China, 300050
        • Research Site
      • Tianjin, China, 300222
        • Research Site
      • Weifang, China, 261000
        • Research Site
      • Wenzhou, China, 325000
        • Research Site
      • Wuhan, China, 430022
        • Research Site
      • Wuhan, China, 430060
        • Research Site
      • Wuhan, China, 430010
        • Research Site
      • Wuhu, China, 241000
        • Research Site
      • Xi'an, China, 710061
        • Research Site
      • Xi'an, China, 710068
        • Research Site
      • Xi'an, China, 710100
        • Research Site
      • Xiamen, China, 361004
        • Research Site
      • Xinxiang, China, 453100
        • Research Site
      • Xuzhou, China, 221009
        • Research Site
      • Yangzhou, China, 225001
        • Research Site
      • Zhangzhou, China, 363000
        • Research Site
      • Zhengzhou, China, 450052
        • Research Site
      • Zhengzhou, China, 450003
        • Research Site
      • Zhengzhou, China, 450007
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Informed Consent

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.

Age 2. Patient must be aged 12-75 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

  • The documentation requirements for demonstrating pulmonary function reversibility are as follows for Screening (Visit 1, Week -1 to Week 0):

    1. For patients diagnosed with asthma ≥1 year prior to enrolment, pulmonary function reports from within 12 months prior to Visit 1 are required: i. If pre- or post-bronchodilator FEV1/FVC ≥70% in reports within 12 months prior to Visit 1: Only objective records of prior reversibility testing confirming asthma diagnosis are required. ii. If both pre- and post-bronchodilator FEV1/FVC <70% in reports within 12 months prior to Visit 1: Must provide objective documentation within 12 months prior to Visit 1 of any of the following:

      • Positive bronchodilator response test, or
      • Positive bronchial provocation test, or
      • Positive PEF diurnal variability (≥10% for adults, ≥13% for children), or
      • PEF improvement ≥20% post-bronchodilator, or
      • Post-treatment FEV1 improvement ≥12% and ≥200mL after 4 weeks of therapy within 12 months prior to Visit 1, or
      • Documented FEV1 variability ≥12% and ≥200mL between two stable visits (non-acute, non-infectious states).
    2. For patients diagnosed with bronchial asthma <1 year prior to enrollment: Require submission of objective documentation within 12 months prior to Visit 1 of any of the above reversibility criteria.
    3. For all enrolled patients meeting inclusion/exclusion criteria: Bronchodilator testing will be conducted during the screening period to establish baseline data for further analysis.

  • Prior to screening (Visit 1, Week -1 to Week 0), patients must have either a documented asthma diagnosis for >6 months or a history of ICS/LABA use for >6 months.

    4. Documented diagnosis of severe eosinophilic asthma (EOS≥150 cells/μL at enrollment, and if EOS 150-<300 cells/μL at enrollment, must have EOS≥300 cells/μL at sometime within 1 year before enrollment) 5. Documented current maintenance treatment with MD/HD ICS + LABA with up to one additional controller

  • Other acceptable asthma controller includes LTRA and LAMA 6. On stable MD/HD ICS(>250μg fluticasone propionate dry powder formulation equivalents total daily dose) + LABA for ≥2 months prior to enrollment (see Appendix F for medium and high daily ICS doses by formulation) 7. For patients on MD ICS/LABA, stable LTRA or LAMA (≥2 weeks) is allowed 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.

    • Source documentation is required for physician-diagnosed asthma, ICS-LABA use and asthma exacerbations over the prior year. A patient verbal history suggestive of asthma symptoms and/or prior asthma exacerbations, but without supporting documentation, is not sufficient to satisfy these inclusion criteria.
    • 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. 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 12 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.
  • All WOCBP must have a negative serum pregnancy test result at Visit 1(Week -1 to Week 0).
  • Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the patient (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) [(periodic abstinence eg, calendar, ovulation,symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception], a vasectomised partner, Implanon®, bilateral tubal occlusion, intrauterine device/levonorgestrel intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™, Xulane™, or NuvaRing®.

Exclusion Criteria:

Medical Conditions

  1. 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.

  2. 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.

  3. 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.
  4. History of alcohol or drug abuse within 12 months prior to Visit 1(Week -1 to Week 0).
  5. 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.
  6. History of anaphylaxis to any biologic therapy.
  7. Known history of allergy or reaction to any component of the study treatment formulation.
  8. 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.
  9. A history of known immunodeficiency disorder, including human immunodeficiency virus.

  10. 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.

  11. Exclusion for any of the following:

    • Previous allogeneic bone marrow transplant.
    • Non-leucocyte depleted whole blood transfusion within 120 days of genetic sample collection.

  12. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:

    1. Affect the safety of the patient throughout the study,
    2. Confound the study results or impact the scientific validity of the data outcome, or
    3. Impede the patient's ability to complete the entire duration of study.

    Prior/Concomitant Therapy

  13. Oral corticosteroid use during 4 weeks prior to Visit 1(Week -1 to Week 0).
  14. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months or 5 halflives (whichever is longer) prior to the date informed consent is obtained.

  15. Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives (whichever is longer) prior to Visit 1(Week -1 to Week 0) or receipt of any investigational non biologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1(Week -1 to Week 0). Exception:

    1. For marketed non-respiratory biologics, it is allowed if the patient is stable on treatment for at least 3 months prior to Visit 1(Week -1 to Week 0) and throughout the study.
    2. Covid-related prevention and treatment
  16. Receipt of live attenuated vaccines 30 days prior to the date of first dose of benralizumab.
  17. Intention to use any concomitant medication that is not permitted or failure to complete the required washout period for a particular prohibited medication.
  18. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
  19. Received bronchial thermoplasty (BT) as treatment of asthma within 12 months prior to Visit 1.
  20. Received treatment with traditional Chinese herbs or proprietary Chinese medicines that have anti-asthmatic effects (excluding topical Chinese herbs) within 4 weeks prior to Visit 1 (Week -1 to Week 0) Prior/Concurrent Clinical Study Experience

  21. Concurrent participation in another clinical study with an Investigational Product or a post-authorization safety study.

    Diagnostic Assessments

  22. Any clinically significant abnormal findings in physical examination, medical history, vital signs, haematology, or clinical chemistry during the enrolment period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete the entire duration of the study.

    Other Exclusions

  23. For females only - currently pregnant (confirmed with positive pregnancy test), breast-feeding, or lactating.
  24. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  25. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  26. Previous enrolment in the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Benralizumab
Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be all treated by study Drug.
Drug: Benralizumab
Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be enrolled into this single arm treatment.
Other Names:
  • Fasenra

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen in the overall patient populationa and by subgroups of baseline background therapy
Time Frame: within 40 weeks after the first administration

Main outcomes: Proportion of patients with at least one controller medication category reduction at end of reduction phase

  • discontinuation of LTRA, or
  • discontinuation of LAMA, or
  • getting to MD ICS/LABA or
  • getting to LD ICS/LABA

Supportive outcomes:

  • Proportion of patients with individual category reduction at end of reduction phase
  • Proportion of patients with ≥2 category reductions in controller medication

  • In sub-group of patients who meet reduction criteria

    • proportion of patients with at least one controller medication category reduction,
    • proportion of patients with individual category reduction
    • proportion of patients with ≥2 reductions in controller medication at end of reduction phase
within 40 weeks after the first administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess overall asthma exacerbation rate during the study of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy
Time Frame: within 56 weeks after first administration
  • Annualized asthma exacerbation rate during the study (from first dose to EOT) and 1-year baseline period
  • Change in annualized asthma exacerbation rate during study phase vs. 1-year baseline period

Annualized asthma exacerbation rate Defined as Number of exacerbations×365.25/(Follow-Up Date-First Benralizumab dose date+1)
within 56 weeks after first administration
To assess standard asthma efficacy measures for benralizumab treated patients when reducing their standard of care asthma controller regimen in the overall patient population a and by subgroups of baseline background therapy
Time Frame: From 16~40 weeks
  • Change in pre-BD FEV1 from beginning of reduction phase to end of reduction phase
  • Change in ACQ-5 and SGRQ from beginning of reduction phase to end of reduction phase
  • Proportion of patients with no deterioration (defined as ACQ-5 change <0.5 since last visit and FEV1 < -100mL compared to beginning of reduction phase) during reduction phase
From 16~40 weeks
To assess if reductions in background therapies achieved at end of reduction phase aremaintained until end of maintenance phase in the overall patient population a and by subgroups of baseline background therapy
Time Frame: From 32-56 weeks
•Proportion of patients at the end of the maintenance phase who use the same background therapy that they achieved at the end of the reduction phase
From 32-56 weeks
To assess standard asthma efficacy measures for benralizumab treated patients at induction phase in the overall patient population and by subgroups of baseline background therapy
Time Frame: from 0-16 weeks
  • Change in FEV1 from beginning of induction phase to end of induction phase
  • Change in ACQ-5 and SGRQ from beginning of induction phase to end of induction phase
  • Proportion of patients achieving ACQ-5 MCID improvement (defined as change in ACQ-5 ≤-0.5 compared to beginning of induction phase) and SGRQ MCID improvement (defined as change in SGRQ ≤-4 compared to beginning of induction phase) during induction phase
from 0-16 weeks
To assess biomarkers of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy
Time Frame: from -1 week to 56 week

Baseline and follow-up visits, and change from baseline:

  • Blood EOS
  • FeNO
  • Total IgE
from -1 week to 56 week
To assess if reductions in background therapies achieved at end of reduction phase aremaintained until end of maintenance phase in the overall patient population a and by subgroups of baseline background therapy
Time Frame: From 40-56 weeks
•Change in ACQ-5, SGRQ and FEV1 from the end of the reduction phase to the end of the maintenance phase
From 40-56 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the changes in small - airway lung function indicators among patients treated with benralizumab in the overall patient populationa and by subgroups of baseline background therapy over the course of the study
Time Frame: from -1 week to 56 week

Change in small - airway lung function indicators from baseline to the end of the maintenance phase:

  • FEF 50%
  • FEF 75%
  • MMEF＆MMEF%pred
from -1 week to 56 week
To explore relationship between baseline characteristic and asthma control level at baseline
Time Frame: -1 week
Baseline characteristics and asthma control levels at baseline
-1 week
To assess the safety and tolerability of benralizumab during the study in patients with severe eosinophilic asthma, while reducing their standard of care asthma controller regimen and maintaining asthma symptom control
Time Frame: from -1 week to 60 week
Frequency of Adverse Events/Serious Adverse Events
from -1 week to 60 week
To assess the safety and tolerability of benralizumab during the study in patients with severe eosinophilic asthma, while reducing their standard of care asthma controller regimen and maintaining asthma symptom control
Time Frame: from -1 week to 56 week
Vital Signsb
from -1 week to 56 week
To assess the safety and tolerability of benralizumab during the study in patients with severe eosinophilic asthma, while reducing their standard of care asthma controller regimen and maintaining asthma symptom control
Time Frame: -1 week, 16 week, 40 week, 56 week
Laboratory variables (chemistry and hematology)
-1 week, 16 week, 40 week, 56 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min Zhang, Professor, ShangHai First General Hospital
  • Principal Investigator: HuaHao Shen, Professor, Second Affiliated Hospital, Zhejiang University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3250L00046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing 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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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