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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002702-12 | EudraCT Number |
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This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.
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In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent Placebo | Placebo Comparator | Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). |
|
| Parent Crenezumab | Experimental | Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crenezumab | Drug | Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks). |
| Percentage of Participants With Anti-Crenezumab Antibodies | Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis. | Baseline up to end of study (up to 54 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shankle Clinic | Newport Beach | California | 92663 | United States | ||
| Anderson Clinical Research, Inc. |
A total of 149 participants were enrolled at 66 centers. These 149 participants represented the Safety Analysis population and data for this population is presented here.
The study was conducted at 66 centers in 16 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Parent Placebo | Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). |
| FG001 | Parent Crenezumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2018 |
Open Label Extension (OLE)
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|
| Redlands |
| California |
| 92374 |
| United States |
| University of California, Davis; Alzheimers Disease Center, Department of Neurology | Sacramento | California | 95817 | United States |
| UCSF - Memory and Aging Center | San Francisco | California | 94158 | United States |
| Neurological Research Inst | Santa Monica | California | 90404 | United States |
| Associated Neurologists PC - Danbury | Danbury | Connecticut | 06810 | United States |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | 06851 | United States |
| Bradenton Research Center | Bradenton | Florida | 34205 | United States |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | United States |
| Alzheimer's Research and Treatment Center | Lake Worth | Florida | 33414 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Bioclinica Research | Orlando | Florida | 32806 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | United States |
| NeuroStudies.net, LLC | Decatur | Georgia | 30033 | United States |
| Alexian Brothers Neurosci Inst | Elk Grove Village | Illinois | 60007 | United States |
| Southern Illinois University, School of Medicine | Springfield | Illinois | 62702 | United States |
| MidAmerica Neuroscience Institute | Prairie Village | Kansas | 66206 | United States |
| MMP Neurology | Scarborough | Maine | 04074 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| Advanced Memory Research Institute of NJ | Toms River | New Jersey | 08755 | United States |
| Behavioral Health Research | Charlotte | North Carolina | 28211 | United States |
| Guilford Neurologic Associates | Greensboro | North Carolina | 27401 | United States |
| Oklahoma Clinical Research | Oklahoma City | Oklahoma | 73112 | United States |
| Summit Research Network Inc. | Portland | Oregon | 97210 | United States |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Sentara Medical Group | Norfolk | Virginia | 23507 | United States |
| National Clinical Research Inc.-Richmond | Richmond | Virginia | 23294 | United States |
| Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre | Heidelberg West | Victoria | 3081 | Australia |
| Neurodegenerative Disorders Research; Neurology | West Perth | Western Australia | 6005 | Australia |
| Parkwood Hospital; Geriatric Medicine | London | Ontario | N6C 5J1 | Canada |
| Kawartha Centre - Redefining Healthy Aging | Peterborough | Ontario | K9H 2P4 | Canada |
| The Centre for Memory and Aging | Toronto | Ontario | M4G 3E8 | Canada |
| Devonshire Clinical Research Inc. | Woodstock | Ontario | N4S 5P5 | Canada |
| Terveystalo Tampere | Tampere | 33100 | Finland |
| Hopital La Grave; Place Lange | Toulouse Cedec | 31059 | France |
| Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie | München | 81675 | Germany |
| Prince of Wales Hospital; Dept. of Medicine & Therapeutics | Hong Kong | Hong Kong |
| Fondazione Santa Lucia IRCCS | Rome | Lazio | 00179 | Italy |
| Ospedale San Giovanni Calibita Fatebenefratell;Neurologia | Rome | Lazio | 00186 | Italy |
| Vilnius University Hospital Santariskiu Clinic | Vilnius | 08661 | Lithuania |
| Hospital Angeles de Culiacán, Neurociencias Estudios ClÃnicos SC | Culiacán | 80020 | Mexico |
| Hospital Uni; Dr. Jose E. Gonzalez | Monterrey | 64460 | Mexico |
| AVIX Investigación ClÃnica S.C | Monterrey | 64710 | Mexico |
| Hospital Universitario de Saltillo | Saltillo | 25000 | Mexico |
| Centrum Medyczne NeuroProtect | Warsaw | 01-684 | Poland |
| State Autonomous Healthcare Institution "Republican Clinical Neurological Center | Kazan' | 420021 | Russia |
| State autonomous institution of healthcare Inter-regional clinical and diagnostic center | Kazan' | 420101 | Russia |
| SHI City Psychoneurological Dispensary #7 (with Hospital) | Saint Petersburg | 190121 | Russia |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Fundació ACE | BArcelon | Barcelona | 08034 | Spain |
| Hospital General De Catalunya; Servicio de Neurologia | Sant Cugat del Vallès | Barcelona | 8195 | Spain |
| Hospital Mutua De Terrasa; Servicio de Neurologia | Terrassa | Barcelona | 08222 | Spain |
| Hospital Virgen del Puerto. Servicio de NeurologÃa | Plasencia | Caceres | 10600 | Spain |
| Clinica Universitaria de Navarra; Servicio de NeurologÃa | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Neurologia | Madrid | 28041 | Spain |
| Ondokuz Mayis Univ. Med. Fac.; Neurology | Samsun | 55139 | Turkey (Türkiye) |
| Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit | Chertsey | KT16 0AE | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Parent Placebo | Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). |
| BG001 | Parent Crenezumab | Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The Safety analysis population was defined as all participants who consented to the OLE study, including those who enrolled in the OLE but did not receive open-label treatment. | Posted | Number | Percentage of Participants | Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks). |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Anti-Crenezumab Antibodies | Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis. | Please note that for this Outcome Measure, no Participants were evaluated at all as the existing immunogenicity data from a parent study (Study BN29552) showed a low potential of Crenezumab to induce Anti-Drug Antibodies (ADAs). | Posted | Baseline up to end of study (up to 54 weeks). |
|
Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parent Placebo | Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). | 0 | 76 | 3 | 76 | 4 | 76 |
| EG001 | Parent Crenezumab | Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). | 0 | 73 | 4 | 73 | 4 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OPTIC ISCHAEMIC NEUROPATHY | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INCARCERATED INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| May 26, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D019636 | Neurodegenerative Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C573372 | crenezumab |
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| Male |
|
| Not Hispanic or Latino |
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| Not Stated |
|
| Black or African American |
|
| Unknown |
|
| White |
|
|