Trial · NCT06465485
STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
NCT06465485, Phase 3, Completed, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma. Trials, record NCT06465485. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06465485
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
- NCT number
- NCT06465485
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 504 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Severe Eosinophilic Asthma
- Interventions
- Benralizumab
- First posted
- 2024-06-18
- Last updated
- 2026-09-03
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | 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 | 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 |
| Secondary | 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 | 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 |
| Secondary | 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 | * 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 |
| Secondary | 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 | * 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) |
| Secondary | 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 | Baseline and follow-up visits, and change from baseline: * Blood EOS * FeNO * Total IgE |
| Secondary | 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 | 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 |
| Other | 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 | 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 |
| Other | To explore relationship between baseline characteristic and asthma control level at baseline | -1 week | Baseline characteristics and asthma control levels at baseline |
| Other | 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 | Frequency of Adverse Events/Serious Adverse Events |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06465485
GET https://conductscience.org/api/trials/v1/NCT06465485/registered