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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.
EU CTIS ID: 2023-507987-38-00
What this study is testing
To evaluate the effect of benralizumab on nasal polyp burden (assessed by nasal endoscopy) and patient-reported nasal blockage (NB).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Female or male patients aged 18 to 75 years inclusive
- 10. Blood eosinophil count of >2% or ≥150/μL at enrolment
- 2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
- 3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
- 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. Ongoing symptoms for at least 12 weeks prior to enrolment
You likely can't join if
- 1. Any nasal and/or sinus surgery within 3 months prior to enrolment
- 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. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
- 4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
- 5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
- 6. Currently pregnant or breastfeeding
See the full eligibility criteria
- 1. Female or male patients aged 18 to 75 years inclusive
- 10. Blood eosinophil count of >2% or ≥150/μL at enrolment
- 2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
- 3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
- 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. Ongoing symptoms for at least 12 weeks prior to enrolment
- 6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
- 7. Bi-weekly mean NBS ≥ 1.5 at randomization
- 8. SNOT-22 total score ≥ 20 at enrolment and randomization
- 9. Documented physician-diagnosed asthma
- 1. Any nasal and/or sinus surgery within 3 months prior to enrolment
- 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. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
- 4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
- 5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
- 6. Currently pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Thailand
- China
- Turkey
- Australia
- Vietnam
- Russian Federation
- Chile
- United States
- Argentina
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Thailand; China; Turkey; Australia; Vietnam and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.