A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
ORCHID
AstraZeneca KK
-
-
RD-clinical-information-Japan@astrazeneca.com
AstraZeneca KK
-
-
RD-clinical-information-Japan@astrazeneca.com
completed
Nov. 25, 2019
40
Interventional
Randomized, Parallel Assignment, Triple
treatment purpose
3
1. Female or male patients aged 18 to 75 years inclusive
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 or more at enrolment
7. Bi-weekly mean NBS 1.5 or more at randomization
8. SNOT-22 total score 20 or more at enrolment and randomization
9. Documented physician-diagnosed asthma
10. Blood eosinophil count of >2% or 150/microL or more at enrolment
1. Any nasal and/or sinus surgery within 3 months prior to enrolment
2. Patients with conditions that makes them non evaluable for the co-primary 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
18age old over
75age old under
Both
Nasal Polyposis
investigational material(s)
Generic name etc : Benralizumab
INN of investigational material : -
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational material : Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses and every 8 weeks thereafter.
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Matching placebo subcutaneously will be injected every 4 weeks for the first 3 doses and every 8 weeks thereafter.
