The aim of this study is to investigate the use of benralizumab in patients with eosinophilic CRSwNP, and comorbid asthma, whose severity is consistent with a need for surgery despite ongoing treatment with intranasal corticosteroids and a history of treatment with systemic corticosteroids or prior surgery for CRSwNP. The effect of benralizumab 30 mg on nasal polyps will be assessed on top of standard of care therapy with INCS over a 56-week treatment period.
ORCHID
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)
Nasal polyps
All genders
18-75
Recruiting now
Overview
Principal Investigator: Christina Cruz, MD
Contact Us
Allison Reeves
Study details
Inclusion Criteria
- Patients with bilateral sinonasal polyps that, despite treatment with a stable daily dose of intranasal corticosteroids and/or prior surgery for nasal polyps, have severity consistent with a need for surgery.
- A documented physician-diagnosed asthma
- Blood eosinophil count of >2%
Exclusion Criteria
- Patients who have undergone any nasal and/or sinus surgery within 3 months prior to the first visit.
- Patients with conditions or concomitant disease like unilateral antrochoanal polyps, nasal septal deviation that occludes at least one nostril, acute sinusitis, nasal infections, upper respiratory infection, current rhinitis medicamentosa, allergic fungal rhinosinusitis, or nasal cavity tumors.
- Patients experiencing an asthma exacerbation requiring systemic corticosteroids treatment or hospitalization for treatment of asthma within 4 weeks prior to the first visit.
Study Requirements
- Make at least 11 in person visits to Tufts Medical Center for 56 weeks
- Provide your health history and medication usage
- Answer questionnaires about your symptoms
- Be examine by the study doctor
- Have 7 nasal endoscopies performed
- Have 2 sinus CT scans
- Give blood 6 times
- Receive the investigational drug by injection 8 times
- Have 10 urine pregnancy tests if you are a female of child-bearing age