Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT05686551
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2022-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718631', 'term': 'tominersen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2022-12-16', 'studyFirstSubmitQcDate': '2023-01-06', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and Severity of Adverse Events (AEs), With Severity Determined According to the AE Severity Grading Scale', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Change From Baseline in Clinical Laboratory Results - Cerebrospinal Fluid (CSF) White Blood Cell (WBC)', 'timeFrame': 'From baseline visit (Day 1), and months 4, 8, 9, 12, 16'}, {'measure': 'Change From Baseline in Clinical Laboratory Results CSF Protein', 'timeFrame': 'From baseline visit (Day 1), and months 4, 8, 9, 12, 16'}, {'measure': 'Change From Baseline in Structural Magnetic Resonance Imaging (MRI) Assessing Any New Abnormalities Including Radiographic Features Consistent With Hydrocephalus and Other Relevant MRI Safety Findings', 'timeFrame': 'From baseline, months 4, 8, 12, 16 and up to approximately month 24'}, {'measure': 'Percentage Change From Baseline in Geometric Means of CSF Mutant Huntingtin (mHTT) Protein Levels at Month 9', 'timeFrame': 'Baseline, Month 9'}, {'measure': "Change From Baseline in Composite Unified Huntington's Disease Rating Scale (cUHDRS) Scores (non-U.S. Sites) at 16 Months", 'timeFrame': 'Baseline to 16 months', 'description': 'Change in scores on the scale.'}, {'measure': 'Change From Baseline in Total Functional Capacity (TFC) Scores (U.S. Sites) at 16 Months', 'timeFrame': 'Baseline to 16 months', 'description': 'Change in scores on the scale.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Montreal Cognitive Assessment (MoCA) Scores', 'timeFrame': 'From baseline, months 4, 8, 12, 16 and up to approximately month 24'}, {'measure': 'Percentage of Participants With Suicidal Ideation or Behavior (I/B) as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) at Each Visit, Including Detailed Focus on Any Individual Cases Identified as Having Severe I/B During the Study Conduct', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Change From Baseline at 16 Months for the Assessments of TFC (non-U.S. Sites) Scores', 'timeFrame': 'Baseline to 16 months'}, {'measure': 'Change From Baseline at 16 Months for the Assessments of cUHDRS (U.S. Sites) Scores', 'timeFrame': 'Baseline to 16 months'}, {'measure': 'Change From Baseline at 16 Months for the Assessments of Symbol Digit Modalities Test (SDMT) Scores', 'timeFrame': 'Baseline to 16 months'}, {'measure': 'Change From Baseline at 16 Months for the Assessments of Stroop Word Reading (SWR) Score', 'timeFrame': 'Baseline to 16 months'}, {'measure': 'Change From Baseline at 16 Months for the Assessment of Total Motor Score (TMS)', 'timeFrame': 'Baseline to 16 months'}, {'measure': 'Change From Baseline in CSF Neurofilament Light Chain (NfL) Levels at 16 Months', 'timeFrame': 'Baseline to 16 months'}, {'measure': 'Incidence of Anti-drug Antibodies (ADAs) at Specified Timepoints Relative to the Prevalence of ADAs at Baseline', 'timeFrame': 'From baseline, months 4, 8, 12, 16 and up to approximately month 24'}, {'measure': 'Titers Determined if ADAs are Identified', 'timeFrame': 'From baseline, months 4, 8, 12, 16 and up to approximately month 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Prodromal and Early Manifest Huntington's Disease"], 'conditions': ['Huntington Disease']}, 'referencesModule': {'references': [{'pmid': '38055260', 'type': 'DERIVED', 'citation': "McColgan P, Thobhani A, Boak L, Schobel SA, Nicotra A, Palermo G, Trundell D, Zhou J, Schlegel V, Sanwald Ducray P, Hawellek DJ, Dorn J, Simillion C, Lindemann M, Wheelock V, Durr A, Anderson KE, Long JD, Wild EJ, Landwehrmeyer GB, Leavitt BR, Tabrizi SJ, Doody R; GENERATION HD1 Investigators. Tominersen in Adults with Manifest Huntington's Disease. N Engl J Med. 2023 Dec 7;389(23):2203-2205. doi: 10.1056/NEJMc2300400. No abstract available."}]}, 'descriptionModule': {'briefSummary': "This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease (HD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n-HD gene expansion mutation carrier status with a cytosine-adenine-guanine-age product (CAP) score of 400-500 inclusive\n\nEither:\n\n* Prodromal HD (defined as Diagnostic Confidence Level (DCL) 2 to 3, Independence Scale (IS) ⩾70, and TFC ⩾8); or\n* Early manifest HD (defined as DCL 4, IS ⩾70, and TFC ⩾8);\n* Total body weight \\> 40 kilograms (kg) and a body mass index (BMI) within the range of 18-32 kilograms per meter square (kg/m2)\n* Study companion\n\nExclusion Criteria\n\n* Current or previous use of an antisense oligonucleotide (ASO) (including small interfering ribonucleic acid \\[RNA\\]) or any huntingtin gene/protein (HTT) lowering therapy (including tominersen)\n* Anti-platelet or anticoagulant therapy within 14 days prior to screening or anticipated use during the study, including, but not limited to, aspirin (unless ≤ 81 milligrams per day \\[mg/day\\]), clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban, apixaban, and heparin\n* History of gene therapy, cell transplantation, or brain surgery\n* Hydrocephalus\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of study drug\n* History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening'}, 'identificationModule': {'nctId': 'NCT05686551', 'briefTitle': "GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "A Phase II, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen in Individuals With Prodromal and Early Manifest Huntington's Disease", 'orgStudyIdInfo': {'id': 'BN42489'}, 'secondaryIdInfos': [{'id': 'Other', 'type': 'OTHER', 'domain': 'GENERATION HD2'}, {'id': '2022-001991-32', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-503928-10-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tominersen 60 milligrams (mg)', 'interventionNames': ['Drug: Tominersen 60 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tominersen 100 mg', 'interventionNames': ['Drug: Tominersen 100 mg']}], 'interventions': [{'name': 'Tominersen 60 mg', 'type': 'DRUG', 'otherNames': ['RO7234292;', 'RG6042'], 'description': '60 mg tominersen administered intrathecally every 16 weeks (Q16W).', 'armGroupLabels': ['Tominersen 60 milligrams (mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo administered intrathecally Q16W.', 'armGroupLabels': ['Placebo']}, {'name': 'Tominersen 100 mg', 'type': 'DRUG', 'otherNames': ['RO7234292;', 'RG6042'], 'description': '100 mg tominersen administered intrathecally Q16W.', 'armGroupLabels': ['Tominersen 100 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Uab Medicine', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 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