STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
STEP
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
1 other identifier
interventional
504
1 country
74
Brief 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.
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 Feb 2024
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2024
CompletedStudy Start
First participant enrolled
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 29, 2026
April 23, 2026
April 1, 2026
2.2 years
February 1, 2024
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population and by subgroups of baseline background therapy Subgroups of 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
within 40 weeks after the first administration
Secondary Outcomes (9)
To assess standard asthma efficacy measures for benralizumab treated patients when reducing their standard of care asthma controller regimen for pulmonary function measured by pre-BD FEV1
From 16~40 weeks
To assess standard asthma efficacy measures for benralizumab treated patients when reducing their standard of care asthma controller regimen for asthma symptoms control measured by ACQ-5 & SGRQ Score
From 16~40 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
from 0-16 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
within 0-16 weeks after first administration
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
within 56 weeks after first administration
- +4 more secondary outcomes
Study Arms (1)
Benralizumab
EXPERIMENTALSevere eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be all treated by study Drug.
Interventions
Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be enrolled into this single arm treatment.
Eligibility Criteria
You may qualify if:
- 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®.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (74)
Research Site
Beijing, 100020, China
Research Site
Beijing, 100029, China
Research Site
Beijing, 100191, China
Research Site
Beijing, 100730, China
Research Site
Changsha, 410005, China
Research Site
Changsha, 410008, China
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Changsha, 410011, China
Research Site
Chengdu, 610014, China
Research Site
Chengdu, 610021, China
Research Site
Chengdu, 610041, China
Research Site
Chengdu, 610072, China
Research Site
Chongqing, 402260, China
Research Site
Guangzhou, 510163, China
Research Site
Guangzhou, 510280, China
Research Site
Guangzhou, 510515, China
Research Site
Guangzhou, 510630, China
Research Site
Guilin, 541001, China
Research Site
Guiyang, 510630, China
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Hangzhou, 310006, China
Research Site
Hangzhou, 310009, China
Research Site
Hefei, 230061, China
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Hefei, 230601, China
Research Site
Hohhot, 010010, China
Research Site
Hohhot, 10050, China
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Huzhou, 313003, China
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Jinan, 250012, China
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Jinan, 250014, China
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Jinan, 250030, China
Research Site
Kunming, CN-650034, China
Research Site
Lanzhou, 730000, China
Research Site
Luoyang, 471000, China
Research Site
Nanjing, 210029, China
Research Site
Nanjing, 211100, China
Research Site
Nanning, 530021, China
Research Site
Ningbo, 315010, China
Research Site
Qingdao, 266042, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200065, China
Research Site
Shanghai, 200080, China
Research Site
Shanghai, 200092, China
Research Site
Shenyang, 110001, China
Research Site
Shenyang, 110004, China
Research Site
Shenzhen, 518001, China
Research Site
Shenzhen, 518036, China
Research Site
Shenzhen, 518039, China
Research Site
Shenzhen, 518101, China
Research Site
Shijiazhuang, 054001, China
Research Site
Shijiazhuang, 50051, China
Research Site
Suzhou, 215004, China
Research Site
Suzhou, 215006, China
Research Site
Taiyuan, 030001, China
Research Site
Taiyuan, 030032, China
Research Site
Tangshan, 63000, China
Research Site
Tianjin, 300050, China
Research Site
Tianjin, 300192, China
Research Site
Tianjin, 300222, China
Research Site
Weifang, 261000, China
Research Site
Wenzhou, 325000, China
Research Site
Wuhan, 430010, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430060, China
Research Site
Wuhu, 241000, China
Research Site
Xi'an, 710061, China
Research Site
Xi'an, 710068, China
Research Site
Xi'an, 710100, China
Research Site
Xiamen, 361004, China
Research Site
Xinxiang, 453100, China
Research Site
Xuzhou, 221009, China
Research Site
Yangzhou, 225001, China
Research Site
Zhangzhou, 363099, China
Research Site
Zhengzhou, 450003, China
Research Site
Zhengzhou, 450007, China
Research Site
Zhengzhou, 450052, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Zhang, Professor
ShangHai First General Hospital
- PRINCIPAL INVESTIGATOR
HuaHao Shen, Professor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2024
First Posted
June 18, 2024
Study Start
February 28, 2024
Primary Completion (Estimated)
May 29, 2026
Study Completion (Estimated)
May 29, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
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 refer 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. A 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", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.