Clinical Trials List
2020-07-01 - 2026-06-30
Phase III
Recruiting6
ICD-10J32.0
Chronic maxillary sinusitis
ICD-9473.0
Chronic sinusitis of maxillary
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)
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Trial Applicant
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Kang-Cheng Su Division of Thoracic Medicine
- Chien-Fu Yeh 未分科
- D.W. Peng Division of Thoracic Medicine
- 趙勻廷 無
- 葉建甫 無
- 黃毓雯 Division of Otolaryngology
- 洪莉婷 無
- Hsin-Kuo Ko Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林怡岑 Division of Otolaryngology
- Te-Huei Yeh Division of Otolaryngology
- 錢穎群 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shang-Fu Hsu 無
- 洪國維 未分科
- Chi-Li Chung 無
- 張廷碩 無
- 林哲玄 Division of Otolaryngology
- 陳彥均 未分科
- Kai-Ling Lee 無
- 呂亦翔 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王興萬 無
- 呂曉薇 無
- 陳美茜 無
- Tsung-Ming Chen 無
- Po-Hao Feng 無
- Pin-Zhir Chao 無
- 林以志 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Endoscopic total nasal polyp score [ Time Frame: Baseline and Week 56 ]
Change in endoscopic total nasal polyp score (nasal polyp score range from 0 to 8, higher scores mean a worse outcome)
Nasal blockage score [ Time Frame: Baseline and week 56 ]
Change in mean nasal blockage score (The severity of nasal blockage can be rated as 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe )
Inclution Criteria
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent form.
Patients with bilateral sinonasal polyps that, despite treatment with standard of care including a history of treatment with Systemic corticosteroids (oral, parenteral) or prior surgery for Nasal polyps have severity consistent with a need for surgery as described by:
A minimum total Nasal polyp score of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at Visit 1 and continuously maintained at Visit 2 to meet the randomisation criterion as determined by the study Imaging Core Lab
Ongoing symptoms for at least 12 weeks prior to Visit 1
Patient-reported moderate to severe nasal blockage (score 2 or 3) over the 2-weeks prior to Visit 1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).
CT Lund Mackay score for ethmoid ≥ maxillary as determined by the study Imaging Core lab.
Patients meet one of the following criteria:
Blood eosinophil count > 5% as determined by central lab
Blood eosinophil count is >2% and ≤ 5% as determined by central lab with a diagnosis of asthma and/or Aspirin exacerbated respiratory disease or NSAID exacerbated respiratory disease
Patients who are on Intranasal corticosteroids or leukotriene receptor antagonists (LTRAs), need to be at stable dose for at least 30 days prior to Visit 1.
SNOT-22 total score ≥ 20 at enrolment (Visit 1).
Exclusion Criteria
Patients who have undergone any nasal and/or sinus surgery within 3 months prior to Visit 1.
Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as:
Unilateral antrochoanal polyps;
Nasal septal deviation that occludes at least one nostril;
Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;
Current rhinitis medicamentosa;
Allergic fungal rhinosinusitis or allergic fungal sinusitis;
Nasal cavity tumours.
Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalisation (>24hrs) for treatment of asthma within 4 weeks prior to Visit 1.
Known history of allergy or reaction to any component of the Investigational product formulation.
Prior/concomitant therapy: use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1 and during the study period.
Alanine aminotransferase or aspartate aminotransferase level ≥ 3 times the upper limit of normal.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
250 participants
