Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-02 @ 4:51 AM
Study NCT ID:
NCT04157335
Status:
TERMINATED
Last Update Posted:
2025-09-08
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden'], 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-17', 'mcpReleaseN': 35, 'releaseDate': '2025-11-28'}], 'estimatedResultsFirstSubmitDate': '2025-11-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009298', 'term': 'Nasal Polyps'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571386', 'term': 'benralizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2025-08-04', 'completionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-11-05', 'dispFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment the safety and tolerability of benralizumab', 'timeFrame': 'Baseline to Week 56', 'description': 'The number of Adverse events (AEs)/serious adverse events (SAEs).'}], 'primaryOutcomes': [{'measure': 'Nasal Polyp Burden', 'timeFrame': 'Baseline to Week 56', 'description': 'Change from baseline in endoscopic total nasal polyp score (NPS).'}, {'measure': 'Patient-reported Nasal Blockage (NB)', 'timeFrame': 'Baseline to week 56', 'description': 'Change from baseline in mean nasal blockage score (NBS).'}], 'secondaryOutcomes': [{'measure': 'Sense of Smell', 'timeFrame': 'Baseline to Week 56', 'description': 'Change from baseline in difficulty with sense of smell (DSS) score'}, {'measure': 'Sinus Opacification by CT Scan', 'timeFrame': 'Baseline to Week 56', 'description': 'Change from baseline in Lund Mackay score'}, {'measure': 'Disease specific health-related quality of life (HRQoL)', 'timeFrame': 'Baseline to Week 56', 'description': 'Change from baseline in SinoNasal Outcome Test (SNOT-22) score.'}, {'measure': 'Nasal Polyp Surgery', 'timeFrame': 'Baseline to Week 56', 'description': 'Time to first nasal polyp surgery'}, {'measure': 'Systemic corticosteroid (SCS) use', 'timeFrame': 'Baseline to Week 56', 'description': 'Time to first SCS course for CRSwNP'}, {'measure': 'Symptoms associated with CRSwNP', 'timeFrame': 'Baseline to Week 56', 'description': 'Change from baseline in nasal symptom score(s)'}, {'measure': 'Nasal polyp surgery and/or systemic corticosteroids (SCS）for relief of nasal symptoms', 'timeFrame': 'Baseline to Week 56', 'description': 'Time to first NP surgery and/or SCS use for CRSwNP'}, {'measure': 'Nasal polyp surgery and/or systemic corticosteroids (SCS）for relief of nasal symptoms', 'timeFrame': 'Baseline to Week 56', 'description': 'Proportion of patients with NP urgery and/orSCS use for CRSwNP'}, {'measure': 'Nasal polyp surgery', 'timeFrame': 'Baseline to Week 56', 'description': 'Proportion of patients with surgery for CRSwNP'}, {'measure': 'Systemic corticosteroids (SCS) use for relief of nasal symptoms', 'timeFrame': 'Baseline to Week 56', 'description': 'Proportion of patients with SCS use for CRSwNP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benralizumab', 'Eosinophilic Chronic Rhinosinusitis with Nasal Polyps', 'Nasal Polyps', 'Asthma'], 'conditions': ['Nasal Polyposis', 'Eosinophilic Chronic Rhinosinusitis']}, 'referencesModule': {'references': [{'pmid': '33710614', 'type': 'DERIVED', 'citation': 'Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Approximately 250 patients will be randomized to receive benralizumab 30 mg SC or matching placebo. After enrolment, eligible patients will enter a 6-week screening/run in period. Patients who meet eligibility criteria will be randomised 1:1 at Week 0 (Day 0) to receive either placebo or benralizumab 30 mg SC 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). An end of treatment visit will be conducted at Week 56.All patients who complete the 56-week DB treatment period on investigational product (IP) may be eligible to continue into around one year OLE (Open Label Extension), during which all patients will receive 8 doses of benralizumab 30 mg. Patients in Benra arm during DB period will receive one dummy dose for the second dose during OLE (Open Label Extension). The last study visit will occur at 8 weeks after the last dose of IP (Week 112/FU). Patients who do not enter OLE (Open Label Extension), will have their last study visit at Week 56 (EoDB) for follow-up and without administration of IP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Female or male patients aged 18 to 75 years inclusive\n2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening and DB period\n3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP\n4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)\n5. Ongoing symptoms for at least 12 weeks prior to enrolment\n6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment\n7. Bi-weekly mean NBS ≥ 1.5 at randomization\n8. SNOT-22 total score ≥ 20 at enrolment and randomization\n9. Documented physician-diagnosed asthma\n10. Blood eosinophil count of \\>2% or ≥150/μL at enrolment\n11. LMS E≥M for Asian\n\nExclusion criteria:\n\n1. Any nasal and/or sinus surgery within 3 months prior to enrolment\n2. Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to:\n\n * Unilateral antrochoanal polyps\n * Nasal septal deviation that occludes at least one nostril\n * Current rhinitis medicamentosa\n * Allergic fungal rhinosinusitis or allergic fungal sinusitis;\n3. 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\n4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.\n5. Receipt of any marketed or investigational biologic product within 6 months of enrolment\n6. Currently pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04157335', 'acronym': 'ORCHID', 'briefTitle': 'Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'D3252C00002'}, 'secondaryIdInfos': [{'id': '2023-507987-38-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '2021-000267-72', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benralizumab', 'description': 'Benralizumab administered subcutaneously', 'interventionNames': ['Biological: Benralizumab 30 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered subcutaneously', 'interventionNames': ['Biological: Matched placebo']}], 'interventions': [{'name': 'Benralizumab 30 mg', 'type': 'BIOLOGICAL', 'description': 'Benralizumab is 30 mg/ml solution for injection in accessorized pre-filled syringe, 1 ml fill volume.\n\nBenralizumab 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).\n\nFor OLE, Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses and every 8 weeks for the rest 5 doses. For the patients on Benralizumab treatment during double blind period, placebo will be dosed at the second dose during OLE.', 'armGroupLabels': ['Benralizumab']}, {'name': 'Matched placebo', 'type': 'BIOLOGICAL', 'description': 'Matching placebo solution for injection in accessorized pre-filled syringe. 1 ml fill volume.\n\nMatching 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).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United 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