A study to evaluate the efficacy and safety of repeating dose of benralizumab administered SC versus placebo in patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps.

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

14 Oct 2021 → 7 Apr 2025

Decision date (initial)

2024-02-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-507987-38-00

EudraCT number

2021-000267-72

ClinicalTrials.gov

NCT04157335

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the effect of benralizumab on nasal polyp burden (assessed
by nasal endoscopy) and patient-reported nasal blockage (NB).

Secondary objectives 2

1. To evaluate the effect of benralizumab on: •Sense of Smell •Sinus Opacification by computed tomography (CT) scan •Disease specific health-related quality of life (HRQoL) •Nasal polyp surgery •Systemic corticosteroid (SCS) use •Symptoms associated with CRSwNP
2. • Nasal polyp surgery and/or systemic corticosteroids (SCS) use for relief of nasal symptoms

Conditions and MedDRA coding

Severe CRSwNP patients with asthma.

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 1. Female or male patients aged 18 to 75 years inclusive
2. 2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
3. 3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
4. 4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
5. 5. Ongoing symptoms for at least 12 weeks prior to enrolment
6. 6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
7. 7. Bi-weekly mean NBS ≥ 1.5 at randomization
8. 8. SNOT-22 total score ≥ 20 at enrolment and randomization
9. 9. Documented physician-diagnosed asthma
10. 10. Blood eosinophil count of >2% or ≥150/μL at enrolment

Exclusion criteria 6

1. 1. Any nasal and/or sinus surgery within 3 months prior to enrolment
2. 2. Patients with conditions that makes them non evaluable for the coprimary efficacy endpoint including but not limited to: • Unilateral antrochoanal polyps • Nasal septal deviation that occludes at least one nostril • Current rhinitis medicamentosa • Allergic fungal rhinosinusitis or allergic fungal sinusitis;
3. 3. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
4. 4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
5. 5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
6. 6. Currently pregnant or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Change form baseline in endoscopic total nasal polyp score (NPS)
2. Change form baseline in mean nasal blockage score(NBS)

Secondary endpoints 8

1. • Change from baseline in difficulty with sense of smell (DSS) score
2. • Change from baseline in Lund Mackay score
3. • Change from baseline in SinoNasal Outcome Test (SNOT-22) score.
4. • Time to first nasal polyp surgery
5. • Time to first SCS course for NP
6. • Change from baseline in nasal symptom score(s)
7. Time to first NP surgery and/or SCS use for CRSwNP.
8. Proportion of patients with NP surgery and/or SCS use for CRSwNP.

Investigational products

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

Test 1

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674

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

Locations

5 EU/EEA countries · 25 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 37 files

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

Application history

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