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| Name | Class |
|---|---|
| JANSSEN Alzheimer Immunotherapy Research & Development, LLC | INDUSTRY |
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This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg/kg AAB-003 | Experimental |
| |
| 1 mg/kg AAB-003 | Experimental |
| |
| 2 mg/kg AAB-003 | Experimental |
| |
| 4 mg/kg AAB-003 | Experimental |
| |
| 8 mg/kg AAB-003 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAB-003 (PF-05236812) | Drug | 0.5 mg/kg AAB-003, IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. | Baseline up to Week 52 |
| Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation). | Baseline up to Week 52 |
| Number of Participants With Potentially Clinically Important Vital Sign Findings | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm); standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg. | Baseline up to Week 52 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer >=6.64 corresponded to positive ADA category value. The number of participants who tested positive on 1 or more occasions is reported. | Baseline, Week 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Clinical | Hallandale | Florida | 33009 | United States | ||
| Munroe Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26925577 | Derived | Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This study enrolled participants who completed the first-in-human (FIH) study, B2601001.
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| ID | Title | Description |
|---|---|---|
| FG000 | AAB-003 0.5 mg/kg | Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions. |
| FG001 | AAB-003 1 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AAB-003 (PF-05236812) |
| Drug |
1 mg/kg AAB-003, IV |
|
| AAB-003 (PF-05236812) | Drug | 2 mg/kg AAB-003, IV |
|
| AAB-003 (PF-05236812) | Drug | 4 mg/kg AAB-003, IV |
|
| AAB-003 (PF-05236812) | Drug | 8 mg/kg AAB-003, IV |
|
| Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=200 msec or >=50% increase from baseline when baseline is less than or equal to 100 msec and >=25% increase when baseline is >100 msec; and QTcF >=450 msec or >=30 msec increase. | Baseline up to Week 52 |
| Number of Participants With Abnormal Physical Examination Findings | A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported. | Baseline up to Week 52 |
| Number of Participants With Abnormal Neurological Examination Findings | Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported. | Baseline up to Week 52 |
| Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. | Baseline up to Week 52 |
| Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance. | Baseline up to Week 52 |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | ADAS-Cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The ADAS-Cog comprises 11 items that are summed to a total score ranging from 0 to 70, with higher scores indicate greater cognitive impairment. | Baseline, Week 52 |
| Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | The DAD is a functional assessment comprised of 40 items (17 items related to self-care and 23 items involving instrumental activities of daily living). The DAD assessment is scored from 0 to 100; higher scores indicate better function. | Baseline, Week 52 |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in subjects with Alzheimer's Disease and other dementias. Twelve behavioral areas are assessed: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement. | Baseline, Week 52 |
| Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | The CDR scale is a dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care. The CDR-SB scale is obtained by summing the ratings in each of the 6 categories, ranging from 0 to 18. Higher scores indicate greater disease severity. | Baseline, Week 52 |
| Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | The MMSE is a brief 30-point questionnaire test that is used to assess cognition. Scores range from 0 to 30, with higher scores indicating better cognitive state. | Baseline, Week 52 |
| Ocala |
| Florida |
| 34471 |
| United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Trinity Care Solutions | Ocala | Florida | 34471 | United States |
| Advanced Imaging of Ocala | Ocala | Florida | 34481 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Foers Medical Arts Pharmacy | Bethesda | Maryland | 20814 | United States |
| CBH Health, LLC | Rockville | Maryland | 20850 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49048 | United States |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | United States |
| KNI Southwest Michigan Imaging Center, LLC | Kalamazoo | Michigan | 49048 | United States |
| Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri | 63141 | United States |
| DePaul Health Center-MRI Department | St Louis | Missouri | 63044 | United States |
| Memory Enhancement Center of America, Inc. | Eatontown | New Jersey | 07724 | United States |
| Central Jersey Radiology | Oakhurst | New Jersey | 07755 | United States |
| Seoul National University Hospital, Department Neurology | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Inha University Hospital, Department of Neurology | Incheon | 400-711 | South Korea |
| Samsung Medical Center, Department of Neurology | Seoul | 1350710 | South Korea |
| Korea University Anam Hospital IRB | Seoul | 136-705 | South Korea |
| ASAN Medical Center | Seoul | 138-736 | South Korea |
| Konkuk University Medical Center, Department of Neurology | Seoul | 143914 | South Korea |
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions. |
| FG002 | AAB-003 2 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions. |
| FG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| FG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| FG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline analysis population included all participants who were enrolled in the study and received at least 1 infusion of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | AAB-003 0.5 mg/kg | Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions. |
| BG001 | AAB-003 1 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions. |
| BG002 | AAB-003 2 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions. |
| BG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| BG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| BG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
| BG006 | 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 |
|
| 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 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions). | Posted | Number | participants | Baseline up to Week 52 |
|
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| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation). | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions). | Posted | Number | participants | Baseline up to Week 52 |
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| Primary | Number of Participants With Potentially Clinically Important Vital Sign Findings | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm); standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg. | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions). | Posted | Number | participants | Baseline up to Week 52 |
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| Primary | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=200 msec or >=50% increase from baseline when baseline is less than or equal to 100 msec and >=25% increase when baseline is >100 msec; and QTcF >=450 msec or >=30 msec increase. | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions). | Posted | Number | participants | Baseline up to Week 52 |
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| Primary | Number of Participants With Abnormal Physical Examination Findings | A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported. | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions). | Posted | Number | participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Neurological Examination Findings | Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported. | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions). | Posted | Number | participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions). | Posted | Number | participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance. | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions). | Posted | Number | participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer >=6.64 corresponded to positive ADA category value. The number of participants who tested positive on 1 or more occasions is reported. | The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions); n=number of evaluable participants at the specified time point. | Posted | Number | participants | Baseline, Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | ADAS-Cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The ADAS-Cog comprises 11 items that are summed to a total score ranging from 0 to 70, with higher scores indicate greater cognitive impairment. | The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | The DAD is a functional assessment comprised of 40 items (17 items related to self-care and 23 items involving instrumental activities of daily living). The DAD assessment is scored from 0 to 100; higher scores indicate better function. | The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in subjects with Alzheimer's Disease and other dementias. Twelve behavioral areas are assessed: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement. | The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | The CDR scale is a dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care. The CDR-SB scale is obtained by summing the ratings in each of the 6 categories, ranging from 0 to 18. Higher scores indicate greater disease severity. | The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | The MMSE is a brief 30-point questionnaire test that is used to assess cognition. Scores range from 0 to 30, with higher scores indicating better cognitive state. | The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
|
Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AAB-003 0.5 mg/kg | Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions. | 0 | 6 | 5 | 6 | ||
| EG001 | AAB-003 1 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions. | 1 | 3 | 3 | 3 | ||
| EG002 | AAB-003 2 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions. | 2 | 12 | 9 | 12 | ||
| EG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. | 3 | 10 | 4 | 10 | ||
| EG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. | 1 | 12 | 10 | 12 | ||
| EG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. | 1 | 9 | 8 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Device breakage | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| bile duct stone | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rectal fissure | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Infusion site bruising | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal bruit | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Carotid bruit | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Parkinsonian gait | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Postural tremor | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Apathy | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypersexuality | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypnopompic hallucination | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Solar lentigo | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Quadranopia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Number of Participants with SAEs |
|
| OG002 | AAB-003 2 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions. |
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions. |
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
| AAB-003 2 mg/kg |
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions. |
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
| OG002 | AAB-003 2 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions. |
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|
| OG003 | AAB-003 4 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. |
| OG004 | AAB-003 8 mg/kg | Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. |
| OG005 | Placebo/AAB-003 | Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. |
|
|