STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
NCT ID: NCT06465485
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
504 participants
INTERVENTIONAL
2024-02-28
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Benralizumab
Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be all treated by study Drug.
Benralizumab
Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be enrolled into this single arm treatment.
Interventions
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Benralizumab
Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be enrolled into this single arm treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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®.
12 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Min Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
ShangHai First General Hospital
HuaHao Shen, Professor
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Research Site
Beijing, , China
Research Site
Beijing, , China
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Beijing, , China
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Beijing, , China
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Changsha, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chengdu, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guilin, , China
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Guiyang, , China
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Hangzhou, , China
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Hangzhou, , China
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Hefei, , China
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Hefei, , China
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Hohhot, , China
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Hohhot, , China
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Huzhou, , China
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Jinan, , China
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Jinan, , China
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Jinan, , China
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Kunming, , China
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Lanzhou, , China
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Luoyang, , China
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Nanjing, , China
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Nanjing, , China
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Nanning, , China
Research Site
Ningbo, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
Research Site
Shenyang, , China
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Shenyang, , China
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Shenzhen, , China
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Shenzhen, , China
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Shenzhen, , China
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Shenzhen, , China
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Shijiazhuang, , China
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Shijiazhuang, , China
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Suzhou, , China
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Suzhou, , China
Research Site
Taiyuan, , China
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Taiyuan, , China
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Tangshan, , China
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Tianjin, , China
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Tianjin, , China
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Tianjin, , China
Research Site
Weifang, , China
Research Site
Wenzhou, , China
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Wuhan, , China
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Wuhan, , China
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Wuhan, , China
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Wuhu, , China
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Xi'an, , China
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Xi'an, , China
Research Site
Xi'an, , China
Research Site
Xiamen, , China
Research Site
Xinxiang, , China
Research Site
Xuzhou, , China
Research Site
Yangzhou, , China
Research Site
Zhangzhou, , China
Research Site
Zhengzhou, , China
Research Site
Zhengzhou, , China
Research Site
Zhengzhou, , China
Countries
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Other Identifiers
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D3250L00046
Identifier Type: -
Identifier Source: org_study_id
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