A trial to learn how well benralizumab works and how safe it is when given in addition to standard asthma treatments in people with eosinophilic asthma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

29 Apr 2025 → ongoing

Decision date (initial)

2025-03-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ORG-100001699

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy and safety of benralizumab in eosinophilic asthma patients uncontrolled on medium-dose ICS-LABA, comparing add-on benralizumab vs escalation therapy with high-dose ICS-LABA

Conditions and MedDRA coding

Eosinophilic Asthma

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001214-PIP01-11

Plan to share IPD

Yes

IPD plan description

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 shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Written informed consent
2. Participant must be 18 to 75 years of age
3. Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
4. Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).
5. Weight of ≥ 35 kg.
6. Pre-BD FEV1 of ≤ 90% predicted
7. Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent
8. ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3
9. Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol
10. Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol
11. At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.

Exclusion criteria 7

1. Important pulmonary disease other than asthma at the discretion of the investigator (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome).
2. Asthma exacerbation requiring use of SCS, or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
3. Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol
4. Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator’s discretion
5. Concurrent participation in another clinical study with an IP or a post-authorisation safety study.
6. Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.
7. History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Endpoint: AAER during the 48-week treatment period.

Secondary endpoints 1

1. Change from baseline in SGRQ total score to EOT (Week 48)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Third parties 9

Locations

7 EU/EEA countries · 75 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 89 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

17 submissions — initial application plus substantial / non-substantial modifications