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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

StatusActive, Not Recruiting
PhasePhase 2
Started2023-02-03
View on ClinicalTrials.gov ↗

Amendment history

2026-08-07
Study Status v45
Completion moved earlier: 2027-04-01 → 2026-10-31
2026-05-21
Study Status v44
Primary completion dateestimated 2026-05-31→confirmed 2026-05-14
2026-02-26
Study Status, Arms and Interventions, Outcome Measures, Eligibility v43
InterventionsPlacebo (Drug), Tominersen 100 mg (Drug), Tominersen 60 mg (Drug)→Placebo (Drug), Tominersen (Drug)
Eligibility criteria+748 characters
Inclusion Criteria: -DB Period: HD gene expansion mutation carrier status with a cytosine-ad [...] stic Confidence Level (DCL) 2 to 3, Independence Scale (IS) ⩾≥70, and TFC ⩾≥8); orOr Early manifest HD (defined as DCL 4, IS ⩾≥70, and TFC ⩾≥8); Total body weight > 40 kilograms (kg) and a body mass index [...] I) within the range of 18-32 kilograms per meter square (kg/m2m^2) Study companion OLE Period: Participants must have completed the DB treatment period Participants must remain in the DB Safety follow-up period until OLE period starts Exclusion Criteria: DB Period: Current or previous use of an antisens [...] [...]
Secondary endpoints10 to 18 entries
DB Period: Change From Baseline in Montreal Cognitive Assessment (MoCA) Scores DB Period: Percentage of Participants With Suicidal Ideation or Behavior (I/B), as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Each Visit, Including Detailed Focus on Any Individual C [...] es Identified as Having Severe I/B During the Study Conduct DB Period: Change From Baseline at 16 Months for the Assessments ofin TFC (non-U.S. Sites) Scores DB Period: Change From Baseline at 16 Months for the Assessments ofin cUHDRS (U.S. Sites) Scores DB Period: Change From Baseline at 16 Months for the Asses [...] [...]
Primary endpoints7 to 11 entries
DB Period: Change From Baseline in Clinical Laboratory Results - CSF Protein DB Period: Change From Baseline in Clinical Laboratory Results - Cerebrospinal Fluid (CSF) White Blood Cell (WBC) ChangeDB FromPeriod: Baseline in Clinical Laboratory Results CSF Protein Change From Baseline in Composite Unified Huntington's Disea [...] Rating Scale (cUHDRS) Scores (non-U.S. Sites) at 16 Months DB Period: Change From Baseline in Structural Magnetic Resonance Imagin [...] t With Hydrocephalus and Other Relevant MRI Safety Findings DB Period: Change From Baseline in Total Functional Capacity (TFC) Scores (U.S. Sites [...] [...]
2025-11-17
Study Status v42
Re-verified, no change to tracked fields
2025-08-19
Study Status, Contacts/Locations v41
Study sites72→70
Show 40 earlier versions
2025-05-22
Study Identification, Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v40
Primary completion date2026-02-28→2026-05-31
Eligibility criteria+158 characters
Key Inclusion Criteria -Huntington's disease (HD) gene expansion mutation carrier status with a cytosine-adenine-guanine-age product (CAP) score of 400-500 inclusive Either: Prodromal HD (defined as Diagnostic Confidence Level (DCL) 2 to 3, Independence Scale (IS) ⩾70, and TFC ⩾TFC88); or Early manifest HD (defined as DCL 4, Independence Scale (IS) ⩾70, and TFC ⩾TFC88); Total body weight > 40 kilograms (kg) and a body mass index (BMI) within the range of 18-32 kilograms per meter square (kg/m2) Study Companioncompanion Key Exclusion Criteria Current or previous use of an antisense oligonucleot [...] [...]
Secondary endpoints10 entries, revised
Change fromFrom baselineBaseline in Montreal Cognitive Assessment (MoCA) Scores Percentage of participantsParticipants withWith suicidalSuicidal ideationIdeation or behaviorBehavior (I/B) as assessedAssessed by Columbia-Suicide Severity Rating Scale (C-SSRS score) at eachEach visitVisit, includingIncluding detailedDetailed focusFocus on anyAny individualIndividual casesCases identifiedIdentified as havingHaving severeSevere ideationI/B or behavior duringDuring the studyStudy conductConduct Change fromFrom baselineBaseline at 16 monthsMonths for the assessmentsAssessments of TFC (non-U.S. sites [...]
Primary endpoints7 entries, revised
Change fromFrom baselineBaseline in TotalClinical FunctionalLaboratory Capacity (TFC) Scores (U.S. sites) at 16 months Change from baseline in clinical laboratory resultsResults - Cerebrospinal fluidFluid (CSF) White Blood Cell (WBC) (1/uL) Change fromFrom baselineBaseline in clinicalClinical laboratoryLaboratory resultsResults CerebrospinalCSF fluid (CSF) protein (g/L)Protein Change fromFrom baselineBaseline in compositeComposite Unified Huntington's Disease Rating Scale (cUHDRS) Scores (non-U.S. sitesSites) at 16 monthsMonths Change inFrom baselineBaseline in structuralStructural Magnetic Re [...] [...]
Study sitesdetails revised at 1 of 72 sites
Study title-1 characters
[...] pants With Prodromal and Early Manifest Huntington's Disease.
2025-03-03
Study Status, IPDSharing v39
Re-verified, no change to tracked fields
2025-02-19
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v38
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 300→confirmed 301
Study sites73→72
2025-02-03
Study Status, Contacts/Locations v37
Study sitesdetails revised at 1 of 73 sites
2025-01-07
Study Status, Contacts/Locations v36
Study sitesdetails revised at 60 of 73 sites
2025-01-01
Study Status, Contacts/Locations v35
Study sites74→73
2024-12-19
Study Status, Contacts/Locations v34
Study sitesdetails revised at 70 of 74 sites
2024-12-02
2 amendments v32-v33
2 re-verifications since 2024-11-02, no change to tracked fields
2024-10-24
Study Status, Contacts/Locations v31
Study sitesdetails revised at 11 of 74 sites
2024-10-04
Study Status, Contacts/Locations v30
Study sitesdetails revised at 9 of 74 sites
2024-09-18
Study Status, Study Description v29
Re-verified, no change to tracked fields
2024-09-15
Study Status, Contacts/Locations v28
Study sitesdetails revised at 11 of 74 sites
2024-09-04
Study Status, Contacts/Locations v27
Study sites73→74
2024-08-05
Study Status, Contacts/Locations v26
Study sitesdetails revised at 5 of 73 sites
2024-07-04
Study Status, Contacts/Locations v25
Study sites72→73
2024-06-07
Study Status, Contacts/Locations v24
Study sites71→72
2024-04-26
Study Status, Contacts/Locations v23
Study sites70→71
2024-03-28
Study Status, Contacts/Locations v22
Study sitesdetails revised at 2 of 70 sites
2024-03-01
Study Status, Contacts/Locations v21
Study sitesdetails revised at 4 of 70 sites
2024-02-02
Study Status, Contacts/Locations v20
Study sitesdetails revised at 3 of 70 sites
2024-01-04
Study Status, Contacts/Locations v19
Primary completion date2025-01-03→2026-02-28
Completion date2027-01-04→2027-04-01
Study sitesdetails revised at 2 of 70 sites
2023-12-06
Study Status, Contacts/Locations v18
Study sites69→70
2023-11-09
Study Status, Contacts/Locations v17
Study sites70→69
2023-11-06
Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v16
Start date2023-01-30→2023-02-03
Enrollment target360→300
Study sites59→70
Eligibility criteria-635 characters
Key Inclusion Criteria Signed-Huntington's studydisease companion consent form. A study companion is required for all participants. (HD) gene expansion mutation carrier status. with a CAP score of 400-500, inclusive, where CAP is calculated as follows Either: Age x (CAG repeat length -33.66) -Prodromal HD, (defined as DCL 2 to 3, TotalIndependence Motor ScoreScale (TMSIS) >6⩾70, and ⩾TFC8); or Early manifest HD (defined as DCL 4, Independence Scale (IS) = 100 (broadly equivalent to HD-ISS Stage 2), or early manifest HD, defined as DCL 4, TMS > 6, 100 >IS>/= ⩾70, and TFC⩾TFC8); Total body weig [...] [...]
Secondary endpointsdetails revised at 3 of 10 entries
2023-09-07
Study Identification, Study Status, Contacts/Locations v15
Study sites54→59
Study title+1 characters
[...] pants With Prodromal and Early Manifest Huntington's Disease.
2023-08-13
Study Identification, Study Status, Contacts/Locations v14
Study sites48→54
Study title-1 characters
[...] pants With Prodromal and Early Manifest Huntington's Disease.
2023-07-24
Study Status, Study Description, Contacts/Locations v13
Study sites45→48
2023-07-12
Study Status, Contacts/Locations v12
Study sites38→45
2023-06-12
Study Status, Contacts/Locations v11
Study sites26→38
2023-05-12
Study Identification, Study Status, Contacts/Locations v10
Study sites21→26
Study title+1 characters
[...] pants With Prodromal and Early Manifest Huntington's Disease.
2023-05-04
Study Status, Study Description, Contacts/Locations v9
Study sites16→21
2023-04-14
Study Status, Contacts/Locations v8
Study sites12→16
2023-03-31
Study Identification, Study Status, Contacts/Locations v7
Study sites11→12
Study title-1 characters
[...] pants With Prodromal and Early Manifest Huntington's Disease.
2023-03-27
Study Status, Contacts/Locations v6
Study sites6→11
2023-03-15
Study Status, Contacts/Locations v5
Study sites5→6
2023-03-12
Study Status, Contacts/Locations v4
Study sites3→5
2023-03-02
Study Status, Contacts/Locations v3
Study sites2→3
2023-02-05
Study Status, Contacts/Locations v2
Study sites1→2
2023-01-30
Study Identification, Study Status, Eligibility v1
Eligibility criteria+662 characters
Key Inclusion Criteria -Signed study companion consent form. A study companion is required for all participants. HD gene expansion mutation carrier status. CAP score of 400-500, inclusive, where CAP is calculated as follows: Age x (CAG repeat length -33.66) -Prodromal HD, defined as DCL 2 to 3, Total Motor Score (TMS) >6, Independence Scale (IS) = 100 (broadly equivalent to HD-ISS Stage 2), or early manifest HD, defined as DCL 4, TMS > 6, 100 >IS>/= 70 [...] CAP score of 400-500, inclusive, where CAP is calculated as follows: Age x (CAG repeat length -33.66) -Prodromal HD, defined as DCL 2 to 3, Tota [...] [...]
Study title+16 characters
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of [...]
2023-01-06
Original filing
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).
Trial Details
NCT Number NCT05686551
Lead Sponsor Hoffmann-La Roche
Conditions Huntington Disease
Enrollment 301 participants
Start Date 2023-02-03
Primary Completion 2026-05-14 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10