Ignite Creation Date:
2025-12-24 @ 12:59 PM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT03558061
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2018-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@alkahest.com', 'phone': '(650) 801-0474', 'title': 'Head of Communications', 'organization': 'Alkahest, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '11 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Active', 'description': 'ALK4290 800 mg daily', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 14, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'ALK4290 800 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '12.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Mean change in BCVA letter score as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) method. The ETDRS chart assesses changes in vision based on the number of letters correctly read by the subject.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Set'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment-emergent Adverse Events (Safety)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'ALK4290 800 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 10 weeks', 'description': 'Treatment-emergent adverse events identified by the Common Terminology Criteria for Adverse Events (CTCAE v4.03)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active', 'description': 'ALK4290 800 mg daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active', 'description': 'ALK4290 800 mg daily'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '8.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hungary', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-15', 'size': 709851, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-12T13:21', 'hasProtocol': True}, {'date': '2018-08-20', 'size': 1394402, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-12T13:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2018-05-15', 'resultsFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2018-06-13', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-13', 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Mean change in BCVA letter score as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) method. The ETDRS chart assesses changes in vision based on the number of letters correctly read by the subject.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (Safety)', 'timeFrame': 'Baseline to 10 weeks', 'description': 'Treatment-emergent adverse events identified by the Common Terminology Criteria for Adverse Events (CTCAE v4.03)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wet Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in newly diagnosed patients with wet age-related macular degeneration (wAMD).', 'detailedDescription': 'This study is designed to evaluate the therapeutic effects and safety of oral ALK4290 administered at 800 mg daily over a 6-week dosing period in newly diagnosed (treatment naïve) patients with wAMD. The study agent will be orally self-administered. All subjects will receive the study agent, ALK4290. This study does not contain a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women with newly diagnosed active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:\n\n * No prior treatment for wAMD in the study eye and no current or planned concomitant intravitreal anti-VEGF treatment in the fellow eye\n * Central subfield retinal thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)\n * Presence of SRF and/or IRF on SD-OCT\n * Any active CNV with subfoveal leakage as determined by FA\n * Total lesion size not greater than 12 disc areas on FA\n * If present, subretinal hemorrhage must comprise \\< 50% of the total lesion area on FA\n * No subfoveal fibrosis or atrophy on FA\n* BCVA letter score, as measured by ETDRS in the study eye, between 70 and 24 letters, inclusive, at screening\n* Patients 50 years of age or older at screening visit 1\n* Body mass index (BMI) between18 and ≤ 40 at screening visit 1\n* Female subjects must not be pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry.\n* Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions\n\nExclusion Criteria:\n\n* Previous participation in any studies of investigational drugs within 1 month preceding screening visit\n* Any form of macular degeneration that is not age-related (e.g., Best's disease, Stargardt's disease, Sorsby's disease, etc.)\n* Additional eye disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (intraocular pressure \\> 24) with visual field loss, clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, or genetic disorders such as retinitis pigmentosa; high myopia \\> 8 diopters)\n* The presence of polypoidal choroidal vasculopathy (PCV) or retinal angiomatous proliferation (RAP) in the study eye\n* Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with fundus photography/FA or SD-OCT\n* Intraocular surgery in the study eye within 3 months prior to screening\n* Aphakia or total absence of the posterior capsule (yttrium aluminum garnet (YAG) laser capsulotomy permitted, a minimum of 1 month prior to enrollment) in the study eye"}, 'identificationModule': {'nctId': 'NCT03558061', 'briefTitle': 'Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkahest, Inc.'}, 'officialTitle': 'A Single Arm Open-Label Study to Evaluate the Therapeutic Effects and Safety of a 6-Week Treatment Regimen of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD)', 'orgStudyIdInfo': {'id': 'ALK4290-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'ALK4290 800 mg daily', 'interventionNames': ['Drug: ALK4290']}], 'interventions': [{'name': 'ALK4290', 'type': 'DRUG', 'otherNames': ['AKST4290', 'BI 144807'], 'description': 'ALK4290 400 mg tablet twice a day', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Budapest', 'country': 'Hungary', 'facility': 'Jahn Ferenc South-Pest Hospital and Clinic', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Borsod-Abauj-Zemplen County Hospital and Teaching Hospital', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Szabolcs-Szatmar-Bereg County Hospital and University Hospital', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'University of Szeged Faculty of Medicine', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Szombathely', 'country': 'Hungary', 'facility': 'Markusovszky University Teaching Hospital', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}], 'overallOfficials': [{'name': 'Alkahest Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkahest, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkahest, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}