Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID) (ORCHID)
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|ClinicalTrials.gov Identifier: NCT04157335|
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Nasal Polyposis||Biological: Benralizumab 30 mg Biological: Matched placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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)|
|Actual Study Start Date :||November 25, 2019|
|Estimated Primary Completion Date :||September 29, 2023|
|Estimated Study Completion Date :||July 29, 2024|
Benralizumab administered subcutaneously
Biological: Benralizumab 30 mg
Benralizumab is 30 mg/ml solution for injection in accessorized pre-filled syringe, 1 ml fill volume.
Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48).
Placebo Comparator: Placebo
Placebo administered subcutaneously
Biological: Matched placebo
Matching placebo solution for injection in accessorized pre-filled syringe. 1 ml fill volume.
Matching placebo subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48).
- Nasal Polyp Burden [ Time Frame: Baseline and Week 56 ]Change from baseline in endoscopic total nasal polyp score (NPS).
- Patient-reported Nasal Blockage (NB) [ Time Frame: Baseline and week 56 ]Change from baseline in mean nasal blockage score (NBS).
- Sense of Smell [ Time Frame: Week 56 ]Change from baseline in difficulty with sense of smell (DSS) score
- Sinus Opacification by CT Scan [ Time Frame: Week 56 ]Change from baseline in Lund Mackay score
- Disease specific health-related quality of life (HRQoL) [ Time Frame: Week 56 ]Change from baseline in SinoNasal Outcome Test (SNOT-22) score.
- Nasal Polyp Surgery [ Time Frame: Week 56 ]Time to first nasal polyp surgery
- Systemic corticosteroid (SCS) use [ Time Frame: Week 56 ]Time to first SCS course for NP
- Symptoms associated with CRSwNP [ Time Frame: Week 56 ]Change from baseline in nasal symptom score(s)
- Assessment the safety and tolerability of benralizumab [ Time Frame: Week 56 ]AEs, Vital signs, Clinical Laboratory and ECG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157335
|Contact: AstraZeneca Clinical Study Information Centerfirstname.lastname@example.org|
|Principal Investigator:||Luo Zhang, Prof. Dr.||Beijing Tongren Hospital|