Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-31 @ 2:12 AM
Study NCT ID:
NCT05295459
Status:
COMPLETED
Last Update Posted:
2025-05-02
First Post:
2022-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-17'}], 'estimatedResultsFirstSubmitDate': '2025-12-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2022-03-08', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure at Week 24 in participants without nasal polyps.', 'timeFrame': 'Week 24', 'description': 'The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.'}], 'secondaryOutcomes': [{'measure': 'CFBL in the 7-day average composite score of 3CS at Week 24.', 'timeFrame': 'Week 24', 'description': 'The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.'}, {'measure': 'CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24.', 'timeFrame': 'Week 24', 'description': 'The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.'}, {'measure': 'CFBL in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis.', 'timeFrame': 'Week 20', 'description': 'Change from baseline in the 3-D volumetric CT score at Week 20.'}, {'measure': 'Rescue treatment requirement through Week 24.', 'timeFrame': 'Week 24', 'description': 'Number and percent of participants requiring rescue treatment through Week 24, this data will be conducted from pooled data from Enlighten 2 and the Enlighten I study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Sinusitis', 'Chronic Rhinosinusitis (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'Multicenter, phase III, randomized, blinded, controlled, parallel group.', 'detailedDescription': 'This is a 24-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18\n* Diagnosed as having CRS\n* Bilateral ethmoid disease confirmed on CT\n* Mean 3 cardinal symptom (3CS) score\n* Undergone at least 2 trials of medical treatments in the past\n* Has been informed of the nature of the study and provided written informed consent\n* Agrees to comply with all study requirements\n* If currently on a waiting list for sinonasal surgery, willing to be removed from the waiting list or have preplanned surgery date cancelled for the duration of the study. \\[Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study\\].\n\nExclusion Criteria:\n\n* Inability to tolerate topical anesthesia\n* Previous nasal surgery\n* Presence of nasal polyp grade 2 or higher\n* Seasonal allergic rhinitis\n* Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids\n* Severe asthma\n* History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis\n* Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy\n* Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT\n* Known history of hypersensitivity or intolerance to corticosteroids\n* Known history of hypothalamic pituitary adrenal axial dysfunction\n* Previous pituitary or adrenal surgery\n* Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.\n* Past or present acute or chronic intracranial or orbital complications of CRS\n* History or diagnosis (in either eye) of glaucoma or ocular hypertension\n* Past or present functional vision in only 1 eye\n* Past, present, or planned organ transplant or chemotherapy with immunosuppression\n* Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection\n* Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening\n* Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments\n* Currently participating in an investigational drug or device study\n* Determined by the investigator as not suitable to be enrolled'}, 'identificationModule': {'nctId': 'NCT05295459', 'briefTitle': 'Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lyra Therapeutics'}, 'officialTitle': 'ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults', 'orgStudyIdInfo': {'id': 'LYR-210-2021-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LYR-210', 'description': 'Single administration of LYR-210 drug matrix (7500 μg)', 'interventionNames': ['Drug: LYR-210', 'Other: Background therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham procedure control', 'description': 'Single mock administration procedure', 'interventionNames': ['Drug: Sham procedure control', 'Other: Background therapy']}], 'interventions': [{'name': 'LYR-210', 'type': 'DRUG', 'description': 'LYR-210 drug matrix (mometasone furoate)', 'armGroupLabels': ['LYR-210']}, {'name': 'Sham procedure control', 'type': 'DRUG', 'description': 'Sham procedure control', 'armGroupLabels': ['Sham procedure control']}, {'name': 'Background therapy', 'type': 'OTHER', 'description': 'Daily Saline Irrigation', 'armGroupLabels': ['LYR-210', 'Sham procedure control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novak Clinical Trials', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'Keck School of Medicine at USC Medical Center', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '90006', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Sensa Health Clinical Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California - 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