Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT05949593
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Eligible subjects will be randomly assigned to begin treatment in 2:1 ratio to receive the study drug (either Tinlarebant 5 mg or matching placebo)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 429}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size', 'timeFrame': 'From baseline to Month 24]'}], 'secondaryOutcomes': [{'measure': 'To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale', 'timeFrame': 'From baseline to Month 24'}, {'measure': 'To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)', 'timeFrame': 'From baseline to Month 24'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LBS-008', 'Tinlarebant', 'GA'], 'conditions': ['Geographic Atrophy']}, 'descriptionModule': {'briefSummary': 'This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.', 'detailedDescription': 'Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.\n* Minimum BCVA is required in the study eye\n\nExclusion Criteria:\n\n* The presence of diabetic macular edema or macular disease in either eye.\n* Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.\n* Uncontrolled diagnosed glaucoma in the study eye'}, 'identificationModule': {'nctId': 'NCT05949593', 'acronym': 'PHOENIX', 'briefTitle': 'Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Belite Bio, Inc'}, 'officialTitle': 'PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study)', 'orgStudyIdInfo': {'id': 'LBS-008-CT05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LBS-008, Tinlarebant', 'interventionNames': ['Drug: Tinlarebant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tinlarebant', 'type': 'DRUG', 'description': '5 mg tablet taken orally once a day', 'armGroupLabels': ['LBS-008, Tinlarebant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets for tinlarebant 5 mg prepared similarly.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92467', 'city': 'Huntington Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '11590', 'city': 'Westbury', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 40.75566, 'lon': -73.58763}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27587', 'city': 'Wake Forest', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 35.97987, 'lon': -78.50972}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15143', 'city': 'Sewickley', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 40.53646, 'lon': -80.1845}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '20186', 'city': 'Warrenton', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 38.71345, 'lon': -77.79527}}, {'zip': '2067', 'city': 'Chatswood', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': -33.8, 'lon': 151.18333}}, {'zip': '2135', 'city': 'Strathfield', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': -33.88096, 'lon': 151.07986}}, {'zip': '4101', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '6009', 'city': 'Crawley', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': -31.98418, 'lon': 115.81603}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '610093', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '10005', 'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510060', 'city': 'Guandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 32.17424, 'lon': 120.10228}}, {'zip': '325027', 'city': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}, {'zip': '70852', 'city': 'Ostrava', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '14000', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '14059', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69130', 'city': 'Écully', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 45.77437, 'lon': 4.77758}}, {'zip': '69317', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '130008', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '1001', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '40447', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '33305', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': 'NR31 6LA', 'city': 'Great Yarmouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 52.60831, 'lon': 1.73052}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'EC1V 2PD', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Belite Study Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Belitebio Clinical Operations', 'role': 'CONTACT', 'email': 'clinicaltrial@belitebio.com', 'phone': '+886 972 080 097'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belite Bio, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}