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Severe Eosinophilic AsthmaPhase 3STEPNCT06465485

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

A Phase 3 study testing Benralizumab in people with Severe Eosinophilic Asthma, run by AstraZeneca at 74 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Severe Eosinophilic Asthma
What is being tested?
Benralizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
504 participants
Where
74 sitesChina
Study dates
28 Feb 2024to 13 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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):
  • 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:
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  • 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).
  • 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.
  • 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®.

Who cannot join

  • 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).
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  • 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.
  • Exclusion for any of the following:
  • Previous allogeneic bone marrow transplant.
  • Non-leucocyte depleted whole blood transfusion within 120 days of genetic sample collection.
  • 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:
  • Affect the safety of the patient throughout the study,
  • Confound the study results or impact the scientific validity of the data outcome, or
  • Impede the patient's ability to complete the entire duration of study.
  • Prior/Concomitant Therapy
  • Oral corticosteroid use during 4 weeks prior to Visit 1(Week -1 to Week 0).
  • 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.
  • 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:
  • 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.
  • Covid-related prevention and treatment
  • Receipt of live attenuated vaccines 30 days prior to the date of first dose of benralizumab.
  • Intention to use any concomitant medication that is not permitted or failure to complete the required washout period for a particular prohibited medication.
  • Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
  • Received bronchial thermoplasty (BT) as treatment of asthma within 12 months prior to Visit 1.
  • 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
  • Concurrent participation in another clinical study with an Investigational Product or a post-authorization safety study.
  • Diagnostic Assessments
  • 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
  • For females only - currently pregnant (confirmed with positive pregnancy test), breast-feeding, or lactating.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • 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.
  • Previous enrolment in the present study.

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

China74 sites

  • Research Site

    Beijing, 100020

  • Research Site

    Beijing, 100029

  • Research Site

    Beijing, 100191

  • Research Site

    Beijing, 100730

  • Research Site

    Changsha, 410005

  • Research Site

    Changsha, 410008

  • Research Site

    Changsha, 410011

  • Research Site

    Chengdu, 610014

  • Research Site

    Chengdu, 610021

  • Research Site

    Chengdu, 610041

  • Research Site

    Chengdu, 610072

  • Research Site

    Chongqing, 402260

  • Research Site

    Guangzhou, 510163

  • Research Site

    Guangzhou, 510280

  • Research Site

    Guangzhou, 510515

  • Research Site

    Guangzhou, 510630

  • Research Site

    Guilin, 541001

  • Research Site

    Guiyang, 510630

  • Research Site

    Hangzhou, 310006

  • Research Site

    Hangzhou, 310009

  • Research Site

    Hefei, 230061

  • Research Site

    Hefei, 230601

  • Research Site

    Hohhot, 010010

  • Research Site

    Hohhot, 10050

  • Research Site

    Huzhou, 313003

  • Research Site

    Jinan, 250012

  • Research Site

    Jinan, 250014

  • Research Site

    Jinan, 250030

  • Research Site

    Kunming, CN-650034

  • Research Site

    Lanzhou, 730000

  • Research Site

    Luoyang, 471000

  • Research Site

    Nanjing, 210029

  • Research Site

    Nanjing, 211100

  • Research Site

    Nanning, 530021

  • Research Site

    Ningbo, 315010

  • Research Site

    Qingdao, 266042

  • Research Site

    Shanghai, 200025

  • Research Site

    Shanghai, 200032

  • Research Site

    Shanghai, 200065

  • Research Site

    Shanghai, 200080

  • Research Site

    Shanghai, 200092

  • Research Site

    Shenyang, 110001

  • Research Site

    Shenyang, 110004

  • Research Site

    Shenzhen, 518001

  • Research Site

    Shenzhen, 518036

  • Research Site

    Shenzhen, 518039

  • Research Site

    Shenzhen, 518101

  • Research Site

    Shijiazhuang, 054001

  • Research Site

    Shijiazhuang, 50051

  • Research Site

    Suzhou, 215004

  • Research Site

    Suzhou, 215006

  • Research Site

    Taiyuan, 030001

  • Research Site

    Taiyuan, 030032

  • Research Site

    Tangshan, 63000

  • Research Site

    Tianjin, 300050

  • Research Site

    Tianjin, 300192

  • Research Site

    Tianjin, 300222

  • Research Site

    Weifang, 261000

  • Research Site

    Wenzhou, 325000

  • Research Site

    Wuhan, 430010

  • Research Site

    Wuhan, 430022

  • Research Site

    Wuhan, 430060

  • Research Site

    Wuhu, 241000

  • Research Site

    Xi'an, 710061

  • Research Site

    Xi'an, 710068

  • Research Site

    Xi'an, 710100

  • Research Site

    Xiamen, 361004

  • Research Site

    Xinxiang, 453100

  • Research Site

    Xuzhou, 221009

  • Research Site

    Yangzhou, 225001

  • Research Site

    Zhangzhou, 363000

  • Research Site

    Zhengzhou, 450003

  • Research Site

    Zhengzhou, 450007

  • Research Site

    Zhengzhou, 450052

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Benralizumab
Medical subject headings
Pulmonary Eosinophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BenralizumabDrug

    Also called Fasenra

    Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be enrolled into this single arm treatment.

Study groups in NCT06465485
Study groupRoleWhat they receive
BenralizumabExperimentalSevere eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be all treated by study Drug.
Receives: Drug: Benralizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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

    Measured: within 40 weeks after the first administration

Secondary outcomes (6)

  1. 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

    • 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

    Measured: From 16~40 weeks

  2. 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

    •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

    Measured: From 32-56 weeks

  3. 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

    • 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

    Measured: from 0-16 weeks

  4. 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

    • 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)

    Measured: within 56 weeks after first administration

  5. To assess biomarkers of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy

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

    • Blood EOS
    • FeNO
    • Total IgE

    Measured: from -1 week to 56 week

  6. 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

    •Change in ACQ-5, SGRQ and FEV1 from the end of the reduction phase to the end of the maintenance phase

    Measured: From 40-56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start28 Feb 2024
  3. Primary completion13 May 2026
  4. Study completion13 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06465485
Sponsor's protocol ID
D3250L00046
Acronym
STEP
Status last verified
Sep 2026
First submitted
1 Feb 2024
Last updated
3 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benralizumab in people with Severe Eosinophilic Asthma, run by AstraZeneca at 74 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06465485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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