Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis Wit… (NCT04157335) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
Stopped: The study has a double-blind period and an open-label period. The study did not meet its primary endpoints after the primary LSLV and the decision was taken to terminate the study early.
United States295 participantsStarted 2019-11-25
Plain-language summary
This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Female or male patients aged 18 to 75 years inclusive
✓. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening and DB period
✓. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
✓. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
✓. Ongoing symptoms for at least 12 weeks prior to enrolment
✓. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
✓. Bi-weekly mean NBS ≥ 1.5 at randomization
✓. SNOT-22 total score ≥ 20 at enrolment and randomization
Exclusion criteria
✕. Any nasal and/or sinus surgery within 3 months prior to enrolment
What they're measuring
1
Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56
Timeframe: Baseline to Week 56
2
Change From Baseline in Mean Nasal Blockage Score (NBS) at Week 56.
. Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to:
✕. Clinically important comorbidities (other eosinophil-driven diseases but CRSwNP) that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
✕. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
✕. Receipt of any marketed or investigational biologic product within 6 months of enrolment