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
Overview
- Phase
- Phase 3
- Intervention
- Benralizumab
- Conditions
- Severe Eosinophilic Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 504
- Locations
- 75
- Primary Endpoint
- 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
- Status
- Active, not recruiting
- Last Updated
- 9 days ago
Overview
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.
Detailed Description
The study population will be approximately 480 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.
Investigators
Eligibility Criteria
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 of ≥40 kg. Sex and Contraceptive/Barrier Requirements
- •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).
Exclusion Criteria
- Not provided
Arms & Interventions
Benralizumab
Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be all treated by study Drug.
Intervention: Benralizumab
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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(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)
- 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.(from -1 week to 60 week)
- To assess biomarkers of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy(from -1 week to 56 week)
- 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 biomarkers of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy(from -1 week to 60 week)