A Phase 2 interventional study of BIIB092 and Placebo in Alzheimer's Disease, sponsored by Biogen. Terminated at 101 sites in 9 countries. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Biogen · Phase 2, Interventional, and Treatment
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.
The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 654 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous (IV) infusion once every 4 weeks OR once every 12 weeks and placebo at the other 4-week dosing visits to maintain the treatment blind.
Drug: BIIB092
Intravenous (IV) infusion once every 4 weeks.
Drug: BIIB092
Intravenous (IV) infusion once every 4 weeks.
Drug: BIIB092
Intravenous (IV) infusion once every 4 weeks.
Drug: Placebo
Administered as specified in treatment arm.
Also known as: Formally known as BMS 986168
Administered as specified in treatment arm.
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
Time frame: Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
LTE Period: Percentage of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
Time frame: From Week 80 to Week 173
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).
Time frame: Baseline, Week 78
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum
Time frame: Baseline up to Week 76
Participants were enrolled at approximately 100 investigational sites from 03 May 2018 to 30 August 2021.
| Milestone | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | LTE Period: BIIB092 125 mg/4 Week | LTE Period: BIIB092 375 mg/12 Week | LTE Period: BIIB092 600 mg/4 Week | LTE Period: BIIB092 2000 mg/4 Week - Early Start | LTE Period: BIIB092 2000 mg/4 Week - Late Start |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 214 | 58 | 58 | 106 | 218 | 0 | 0 | 0 | 0 | 0 |
| Safety analysis set | 214 | 58 | 58 | 106 | 214 | 0 | 0 | 0 | 0 | 0 |
| Full analysis set (fas) | 214 | 58 | 58 | 106 | 214 | 0 | 0 | 0 | 0 | 0 |
| Antidrug antibody (ada) evaluable set | 211 | 57 | 57 | 105 | 212 | 0 | 0 | 0 | 0 | 0 |
| Completed | 172 | 48 | 50 | 91 | 175 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 42 | 10 | 8 | 15 | 43 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 10 | 1 | 1 | 0 | 5 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Noncompliance with study drug | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol deviation | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Randomized by mistake | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Site terminated by sponsor | 2 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by participant-study visit burden/scheduling conflicts | 7 | 1 | 1 | 0 | 5 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by participant-concern about study procedures/perceived risks | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by participant-relocation (moving or has moved) | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by participant-desire for change in treatment (unrelated to safety) | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by participant-other | 6 | 2 | 2 | 5 | 7 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Wbp/g-study visit burden/scheduling conflicts | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Wbp/g-concern about study procedures/perceived risks | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Wbp/g-desire for change in treatment (unrelated to safety) | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Wbp/g-unable to continue to enable participation due to illness/hospitalization/death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Wbp/g-other | 0 | 2 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision-unrelated to safety | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 5 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Not dosed | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 |
| Milestone | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | LTE Period: BIIB092 125 mg/4 Week | LTE Period: BIIB092 375 mg/12 Week | LTE Period: BIIB092 600 mg/4 Week | LTE Period: BIIB092 2000 mg/4 Week - Early Start | LTE Period: BIIB092 2000 mg/4 Week - Late Start |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 46 | 49 | 90 | 169 | 167 |
| Safety analysis set | 0 | 0 | 0 | 0 | 0 | 45 | 49 | 89 | 168 | 165 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 46 | 49 | 90 | 169 | 167 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| Withdrew: Site terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 38 | 49 | 75 | 151 | 154 |
| Withdrew: Withdrawal by participant-study visit burden/scheduling conflicts | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 5 | 3 | 3 |
| Withdrew: Withdrawal by participant-relocation (moving or has moved) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 |
| Withdrew: Withdrawal by participant-other | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 4 |
| Withdrew: Wbp/g-study visit burden/scheduling conflicts | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
| Withdrew: Wbp/g-concern about study procedures/perceived risks | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Wbp/g-relocation (moving or has moved) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Wbp/g-unable to continue to enable participation due to illness/hospitalization/death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 |
| Withdrew: Wbp/g-other | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
| percentage of participants | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week |
|---|---|---|---|---|---|
| AEs | 84.6 | 86.2 | 82.8 | 88.7 | 88.3 |
| SAEs | 12.1 | 10.3 | 10.3 | 12.3 | 11.7 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
| percentage of participants | LTE Period: BIIB092 125 mg/4 Week | LTE Period: BIIB092 375 mg/12 Week | LTE Period: BIIB092 600 mg/4 Week | LTE Period: BIIB092 2000 mg/4 Week - Early Start | LTE Period: BIIB092 2000 mg/4 Week - Late Start |
|---|---|---|---|---|---|
| AEs | 68.9 | 55.1 | 58.4 | 61.3 | 60.0 |
| SAEs | 11.1 | 2.0 | 10.1 | 6.0 | 7.9 |
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).
| score on a scale | PC Period: Placebo | PC Period: BIIB092 Low Dose | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week |
|---|---|---|---|---|
| Baseline | 3.07 ± 1.467 | 2.92 ± 1.620 | 3.24 ± 1.557 | 3.04 ± 1.378 |
| Change at Week 78 | 1.71 ± 2.376 | 2.10 ± 2.375 | 2.23 ± 2.987 | 1.76 ± 2.038 |
| percentage of participants | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week |
|---|---|---|---|---|---|
| PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum | 1.9 | 0 | 0 | 1.0 | 0 |
Collected over From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PC Period: Placebo | 1/214 (0.5%) | 26/214 (12.1%) | 121/214 (56.5%) |
| PC Period: BIIB092 125 mg/4 Week | 1/58 (1.7%) | 6/58 (10.3%) | 39/58 (67.2%) |
| PC Period: BIIB092 375 mg/12 Week | 0/58 (0%) | 6/58 (10.3%) | 38/58 (65.5%) |
| PC Period: BIIB092 600 mg/4 Week | 0/106 (0%) | 13/106 (12.3%) | 68/106 (64.2%) |
| PC Period: BIIB092 2000 mg/4 Week | 1/214 (0.5%) | 25/214 (11.7%) | 139/214 (65%) |
| LTE Period: BIIB092 125 mg/4 Week | 2/45 (4.4%) | 5/45 (11.1%) | 10/45 (22.2%) |
| LTE Period: BIIB092 375 mg/12 Week | 0/49 (0%) | 1/49 (2%) | 11/49 (22.4%) |
| LTE Period: BIIB092 600 mg/4 Week | 1/89 (1.1%) | 9/89 (10.1%) | 19/89 (21.3%) |
| LTE Period: BIIB092 2000 mg/4 Week - Early Start | 1/168 (0.6%) | 10/168 (6%) | 28/168 (16.7%) |
| LTE Period: BIIB092 2000 mg/4 Week - Late Start | 1/165 (0.6%) | 13/165 (7.9%) | 29/165 (17.6%) |
| Event | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | LTE Period: BIIB092 125 mg/4 Week | LTE Period: BIIB092 375 mg/12 Week | LTE Period: BIIB092 600 mg/4 Week | LTE Period: BIIB092 2000 mg/4 Week - Early Start | LTE Period: BIIB092 2000 mg/4 Week - Late Start |
|---|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarctionCardiac disorders | 0/214 | 0/58 | 0/58 | 0/106 | 0/214 | 1/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| Oesophageal ulcer haemorrhageGastrointestinal disorders | 0/214 | 0/58 | 0/58 | 0/106 | 0/214 | 1/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| Hip fractureInjury, poisoning and procedural complications | 0/214 | 0/58 | 0/58 | 1/106 | 0/214 | 1/45 | 0/49 | 0/89 | 0/168 | 1/165 |
| Hepatocellular carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/214 | 0/58 | 0/58 | 0/106 | 0/214 | 1/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| Transient ischaemic attackNervous system disorders | 0/214 | 0/58 | 0/58 | 1/106 | 0/214 | 1/45 | 0/49 | 0/89 | 0/168 | 1/165 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/214 | 0/58 | 0/58 | 0/106 | 0/214 | 1/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| Deep vein thrombosisVascular disorders | 0/214 | 0/58 | 0/58 | 0/106 | 0/214 | 1/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| FallInjury, poisoning and procedural complications | 2/214 | 1/58 | 1/58 | 1/106 | 1/214 | 0/45 | 1/49 | 0/89 | 3/168 | 3/165 |
| Femoral neck fractureInjury, poisoning and procedural complications | 0/214 | 0/58 | 0/58 | 0/106 | 0/214 | 0/45 | 1/49 | 0/89 | 1/168 | 0/165 |
| Device dislocationProduct Issues | 0/214 | 0/58 | 0/58 | 0/106 | 0/214 | 0/45 | 1/49 | 0/89 | 0/168 | 0/165 |
| Event | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | LTE Period: BIIB092 125 mg/4 Week | LTE Period: BIIB092 375 mg/12 Week | LTE Period: BIIB092 600 mg/4 Week | LTE Period: BIIB092 2000 mg/4 Week - Early Start | LTE Period: BIIB092 2000 mg/4 Week - Late Start |
|---|---|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 12/214 | 11/58 | 3/58 | 6/106 | 11/214 | 0/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| FallInjury, poisoning and procedural complications | 23/214 | 6/58 | 11/58 | 19/106 | 30/214 | 5/45 | 7/49 | 6/89 | 14/168 | 15/165 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 14/214 | 6/58 | 7/58 | 9/106 | 19/214 | 0/45 | 3/49 | 4/89 | 6/168 | 3/165 |
| NasopharyngitisInfections and infestations | 22/214 | 4/58 | 6/58 | 9/106 | 24/214 | 0/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| HeadacheNervous system disorders | 20/214 | 1/58 | 6/58 | 11/106 | 22/214 | 1/45 | 3/49 | 4/89 | 3/168 | 6/165 |
| COVID-19Infections and infestations | 0/214 | 0/58 | 0/58 | 0/106 | 0/214 | 2/45 | 1/49 | 9/89 | 2/168 | 3/165 |
| Urinary tract infectionInfections and infestations | 13/214 | 5/58 | 3/58 | 8/106 | 20/214 | 0/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| ConstipationGastrointestinal disorders | 8/214 | 5/58 | 1/58 | 2/106 | 6/214 | 0/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| Upper respiratory tract infectionInfections and infestations | 15/214 | 5/58 | 3/58 | 6/106 | 15/214 | 0/45 | 0/49 | 0/89 | 0/168 | 0/165 |
| Back painMusculoskeletal and connective tissue disorders | 16/214 | 5/58 | 3/58 | 9/106 | 13/214 | 3/45 | 0/49 | 2/89 | 5/168 | 5/165 |
Randomized participants included enrolled participants who received a randomization treatment assignment from the Interactive Response Technology (BIIB092 or placebo).
| Age, Continuous(years) | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | Total |
|---|---|---|---|---|---|---|
| Mean | 69.8 ± 6.63 | 70.4 ± 6.80 | 70.3 ± 6.79 | 69.7 ± 6.66 | 69.4 ± 7.11 | 69.7 ± 6.81 |
| Sex: Female, Male(Participants) | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | Total |
|---|---|---|---|---|---|---|
| Female | 106 | 28 | 26 | 55 | 114 | 329 |
| Male | 108 | 30 | 32 | 51 | 104 | 325 |
| Ethnicity (NIH/OMB)(Participants) | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 2 | 1 | 9 | 17 |
| Not Hispanic or Latino | 208 | 53 | 55 | 103 | 208 | 627 |
| Unknown or Not Reported | 3 | 3 | 1 | 2 | 1 | 10 |
| Race (NIH/OMB)(Participants) | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 0 | 1 |
| Asian | 5 | 3 | 2 | 6 | 7 | 23 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 0 | 1 | 1 | 1 | 7 |
| White | 201 | 53 | 53 | 98 | 206 | 611 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 2 | 2 | 1 | 4 | 12 |
Showing the first 100 of 101 sites across 9 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Data sharing details ↗ · vivli.org
Ran from May 2018 to primary completion in Aug 2021, 39 months.
Results were first posted in Nov 2022, 1 year 2 months after primary completion.
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Studies of the drug tested here: Gosuranemab