Parkinson's Disease (PD)
Conditions
Keywords
Parkinson's Disease (PD), ABBV-951, Levodopa/Carbidopa
Brief summary
The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.
Interventions
DRUGABBV-951
Solution for continuous subcutaneous infusion (CSCI)
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive * Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable Off and On states (motor fluctuations), and have a minimum of 2.5 hours of Off time per day
Exclusion criteria
* Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study * Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Baseline, Day 1 (postdose), Weeks 6 and 52 | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. |
| Specific Gravity (Urinalysis): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine) | Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection. |
| Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine) | Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection. |
| Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine) | Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection. |
| Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Baseline, Day 1 (postdose), Weeks 6 and 52 | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. |
| Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Baseline, Day 1 (postdose), Weeks 6 and 52 | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. |
| Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Baseline, Day 1 (postdose), Weeks 6 and 52 | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. |
| Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Baseline, Day 1 (postdose), Weeks 6 and 52 | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. |
| Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Baseline, Day 1 (postdose), Weeks 6 and 52 | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. |
| Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Baseline, Day 1 (postdose), Weeks 6 and 52 | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. |
| Number of Participants With Adverse Events | From first dose of study drug until 30 days following last dose of study drug (up to 480 days) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. |
| Number of Participants With Adverse Events of Special Interest | From first dose of study drug until 30 days following last dose of study drug (up to 480 days) | Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug. |
| Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale | Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52 | Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria \> 2 or \> C was recorded as an adverse event (AE). |
| Hematocrit (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Hemoglobin (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Neutrophils (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Lymphocytes (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Monocytes (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Sodium (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Potassium (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Calcium (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Albumin (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Glucose (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Baseline, Weeks 6, 26, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
| pH (Urinalysis): Change From Baseline to End of Study | Baseline, Weeks 6, 26, 39, and 52 | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Baseline, Weeks 1, 6, 13, 26, 39, and 52 | Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. On time is defined as periods of good motor symptom control. The daily On and Off times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized On time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement. |
| Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Baseline, Weeks 1, 6, 13, 26, 39, and 52 | Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. On time is defined as periods of good motor symptom control. The daily On and Off times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized On time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement. |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52 | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement. |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52 | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement. |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52 | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement. |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52 | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement. |
| Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Baseline, Weeks 6, 13, 26, 39, and 52 | The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 \[never\] to 4 \[very often\] with the exception of Question 1 score ranging from 0 \[very often\] to 4 \[never\]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline. |
| Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Baseline, Weeks 6, 13, 26, 39, and 52 | The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline. |
| The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Baseline, Weeks 6, 13, 26, 39, and 52 | The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement. |
| Average Daily Normalized Off Time: Change From Baseline to End of Study | Baseline, Weeks 1, 6, 13, 26, 39, and 52 | Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. Off time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily On and Off times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When Off was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized Off time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement. |
Countries
Australia, Belgium, Canada, Denmark, Germany, Italy, Japan, Netherlands, Russia, Spain, Sweden, United Kingdom, United States
Participant flow
Pre-assignment details
All enrolled participants
Participants by arm
| Arm | Count |
|---|---|
| ABBV-951 Low Dose Subgroup After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | 131 |
| ABBV-951 High Dose Subgroup After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | 113 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 23 | 25 |
| Overall Study | Difficulty with drug delivery system | 2 | 3 |
| Overall Study | Lack of Efficacy | 4 | 5 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other, not specified | 2 | 2 |
| Overall Study | Withdrew consent | 16 | 12 |
Baseline characteristics
| Characteristic | ABBV-951 High Dose Subgroup | Total | ABBV-951 Low Dose Subgroup |
|---|---|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 9.54 | 63.9 years STANDARD_DEVIATION 9.18 | 63.5 years STANDARD_DEVIATION 8.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 20 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 224 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 34 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 105 Participants | 207 Participants | 102 Participants |
| Sex: Female, Male Female | 32 Participants | 98 Participants | 66 Participants |
| Sex: Female, Male Male | 81 Participants | 146 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 5 / 113 | 5 / 244 |
| other Total, other adverse events | 111 / 131 | 107 / 113 | 218 / 244 |
| serious Total, serious adverse events | 32 / 131 | 31 / 113 | 63 / 244 |
Outcome results
Primary
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 6 | 4.59 cells*10^9/L | Standard Deviation 36.489 |
| ABBV-951 Low Dose Subgroup | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 26 | -1.68 cells*10^9/L | Standard Deviation 43.279 |
| ABBV-951 Low Dose Subgroup | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 39 | -3.90 cells*10^9/L | Standard Deviation 43.848 |
| ABBV-951 Low Dose Subgroup | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 52 | -3.41 cells*10^9/L | Standard Deviation 41.12 |
| ABBV-951 High Dose Subgroup | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 52 | -10.63 cells*10^9/L | Standard Deviation 44.537 |
| ABBV-951 High Dose Subgroup | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 6 | 0.39 cells*10^9/L | Standard Deviation 40.844 |
| ABBV-951 High Dose Subgroup | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 39 | -7.29 cells*10^9/L | Standard Deviation 49.222 |
| ABBV-951 High Dose Subgroup | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 26 | -10.39 cells*10^9/L | Standard Deviation 43.757 |
| ABBV-951 All Participants | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 52 | -6.58 cells*10^9/L | Standard Deviation 42.628 |
| ABBV-951 All Participants | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 26 | -5.74 cells*10^9/L | Standard Deviation 43.556 |
| ABBV-951 All Participants | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 39 | -5.37 cells*10^9/L | Standard Deviation 46.084 |
| ABBV-951 All Participants | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Week 6 | 2.54 cells*10^9/L | Standard Deviation 38.635 |
Primary
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 6 | -0.27 seconds | Standard Deviation 2.151 |
| ABBV-951 Low Dose Subgroup | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 26 | -0.02 seconds | Standard Deviation 1.898 |
| ABBV-951 Low Dose Subgroup | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 39 | 0.14 seconds | Standard Deviation 1.556 |
| ABBV-951 Low Dose Subgroup | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 52 | -0.09 seconds | Standard Deviation 2.156 |
| ABBV-951 High Dose Subgroup | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 52 | 0.88 seconds | Standard Deviation 2.992 |
| ABBV-951 High Dose Subgroup | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 6 | 0.55 seconds | Standard Deviation 2.483 |
| ABBV-951 High Dose Subgroup | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 39 | 0.67 seconds | Standard Deviation 3.672 |
| ABBV-951 High Dose Subgroup | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 26 | 0.48 seconds | Standard Deviation 1.932 |
| ABBV-951 All Participants | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 52 | 0.32 seconds | Standard Deviation 2.573 |
| ABBV-951 All Participants | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 26 | 0.20 seconds | Standard Deviation 1.922 |
| ABBV-951 All Participants | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 39 | 0.36 seconds | Standard Deviation 2.661 |
| ABBV-951 All Participants | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Week 6 | 0.13 seconds | Standard Deviation 2.347 |
Primary
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -1.65 g/L | Standard Deviation 2.782 |
| ABBV-951 Low Dose Subgroup | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -1.31 g/L | Standard Deviation 2.541 |
| ABBV-951 Low Dose Subgroup | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -1.75 g/L | Standard Deviation 2.782 |
| ABBV-951 Low Dose Subgroup | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -1.96 g/L | Standard Deviation 2.949 |
| ABBV-951 High Dose Subgroup | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -1.02 g/L | Standard Deviation 3.205 |
| ABBV-951 High Dose Subgroup | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -1.95 g/L | Standard Deviation 2.885 |
| ABBV-951 High Dose Subgroup | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -1.56 g/L | Standard Deviation 2.507 |
| ABBV-951 High Dose Subgroup | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -1.14 g/L | Standard Deviation 2.558 |
| ABBV-951 All Participants | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -1.55 g/L | Standard Deviation 3.086 |
| ABBV-951 All Participants | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -1.23 g/L | Standard Deviation 2.541 |
| ABBV-951 All Participants | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -1.67 g/L | Standard Deviation 2.658 |
| ABBV-951 All Participants | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -1.79 g/L | Standard Deviation 2.829 |
Primary
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -1.91 U/L | Standard Deviation 12.394 |
| ABBV-951 Low Dose Subgroup | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 1.68 U/L | Standard Deviation 18.995 |
| ABBV-951 Low Dose Subgroup | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -2.28 U/L | Standard Deviation 12.252 |
| ABBV-951 Low Dose Subgroup | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.55 U/L | Standard Deviation 18.637 |
| ABBV-951 High Dose Subgroup | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -1.54 U/L | Standard Deviation 13.796 |
| ABBV-951 High Dose Subgroup | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -4.56 U/L | Standard Deviation 12.34 |
| ABBV-951 High Dose Subgroup | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -5.02 U/L | Standard Deviation 16.088 |
| ABBV-951 High Dose Subgroup | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -2.86 U/L | Standard Deviation 14.157 |
| ABBV-951 All Participants | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.35 U/L | Standard Deviation 16.697 |
| ABBV-951 All Participants | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.39 U/L | Standard Deviation 17.051 |
| ABBV-951 All Participants | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -3.46 U/L | Standard Deviation 14.049 |
| ABBV-951 All Participants | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -3.19 U/L | Standard Deviation 12.408 |
Primary
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 0.02 mmol/L | Standard Deviation 1.348 |
| ABBV-951 Low Dose Subgroup | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.21 mmol/L | Standard Deviation 1.489 |
| ABBV-951 Low Dose Subgroup | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.41 mmol/L | Standard Deviation 1.852 |
| ABBV-951 Low Dose Subgroup | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.16 mmol/L | Standard Deviation 1.836 |
| ABBV-951 High Dose Subgroup | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.15 mmol/L | Standard Deviation 1.342 |
| ABBV-951 High Dose Subgroup | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.01 mmol/L | Standard Deviation 1.56 |
| ABBV-951 High Dose Subgroup | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.05 mmol/L | Standard Deviation 1.659 |
| ABBV-951 High Dose Subgroup | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.17 mmol/L | Standard Deviation 1.6 |
| ABBV-951 All Participants | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.16 mmol/L | Standard Deviation 1.636 |
| ABBV-951 All Participants | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.19 mmol/L | Standard Deviation 1.535 |
| ABBV-951 All Participants | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.25 mmol/L | Standard Deviation 1.773 |
| ABBV-951 All Participants | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 0.00 mmol/L | Standard Deviation 1.45 |
Primary
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.02 mmol/L | Standard Deviation 0.079 |
| ABBV-951 Low Dose Subgroup | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.03 mmol/L | Standard Deviation 0.08 |
| ABBV-951 Low Dose Subgroup | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.04 mmol/L | Standard Deviation 0.091 |
| ABBV-951 Low Dose Subgroup | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.06 mmol/L | Standard Deviation 0.084 |
| ABBV-951 High Dose Subgroup | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.04 mmol/L | Standard Deviation 0.092 |
| ABBV-951 High Dose Subgroup | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.04 mmol/L | Standard Deviation 0.086 |
| ABBV-951 High Dose Subgroup | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.05 mmol/L | Standard Deviation 0.087 |
| ABBV-951 High Dose Subgroup | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.04 mmol/L | Standard Deviation 0.091 |
| ABBV-951 All Participants | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.05 mmol/L | Standard Deviation 0.088 |
| ABBV-951 All Participants | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.03 mmol/L | Standard Deviation 0.085 |
| ABBV-951 All Participants | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.05 mmol/L | Standard Deviation 0.089 |
| ABBV-951 All Participants | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.03 mmol/L | Standard Deviation 0.083 |
Primary
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 2.52 U/L | Standard Deviation 56.209 |
| ABBV-951 Low Dose Subgroup | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 5.61 U/L | Standard Deviation 51.627 |
| ABBV-951 Low Dose Subgroup | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 8.40 U/L | Standard Deviation 96.021 |
| ABBV-951 Low Dose Subgroup | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 30.39 U/L | Standard Deviation 125.044 |
| ABBV-951 High Dose Subgroup | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -16.55 U/L | Standard Deviation 85.305 |
| ABBV-951 High Dose Subgroup | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -11.01 U/L | Standard Deviation 94.662 |
| ABBV-951 High Dose Subgroup | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -9.67 U/L | Standard Deviation 75.655 |
| ABBV-951 High Dose Subgroup | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -15.44 U/L | Standard Deviation 62.435 |
| ABBV-951 All Participants | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 10.17 U/L | Standard Deviation 111.783 |
| ABBV-951 All Participants | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -3.83 U/L | Standard Deviation 57.48 |
| ABBV-951 All Participants | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.66 U/L | Standard Deviation 88.002 |
| ABBV-951 All Participants | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -4.01 U/L | Standard Deviation 77.285 |
Primary
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.08 mL/sec/1.73m^2 | — |
| ABBV-951 High Dose Subgroup | Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 0.00 mL/sec/1.73m^2 | — |
| ABBV-951 High Dose Subgroup | Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.17 mL/sec/1.73m^2 | — |
| ABBV-951 All Participants | Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.04 mL/sec/1.73m^2 | Standard Deviation 0.059 |
| ABBV-951 All Participants | Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.17 mL/sec/1.73m^2 | — |
Primary
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -4.45 µmol/L | Standard Deviation 9.227 |
| ABBV-951 Low Dose Subgroup | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -2.71 µmol/L | Standard Deviation 10.478 |
| ABBV-951 Low Dose Subgroup | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -1.47 µmol/L | Standard Deviation 12.414 |
| ABBV-951 Low Dose Subgroup | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -4.78 µmol/L | Standard Deviation 11.446 |
| ABBV-951 High Dose Subgroup | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -5.21 µmol/L | Standard Deviation 9.941 |
| ABBV-951 High Dose Subgroup | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -5.67 µmol/L | Standard Deviation 10.725 |
| ABBV-951 High Dose Subgroup | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -4.02 µmol/L | Standard Deviation 10.182 |
| ABBV-951 High Dose Subgroup | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -4.07 µmol/L | Standard Deviation 12.074 |
| ABBV-951 All Participants | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -4.96 µmol/L | Standard Deviation 10.785 |
| ABBV-951 All Participants | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -3.33 µmol/L | Standard Deviation 11.213 |
| ABBV-951 All Participants | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -2.58 µmol/L | Standard Deviation 11.527 |
| ABBV-951 All Participants | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -5.04 µmol/L | Standard Deviation 9.968 |
Primary
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Week 6 | 0.5 milliseconds | Standard Deviation 13.97 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Day 1 (postdose) | 0.4 milliseconds | Standard Deviation 14.08 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Week 52 | 1.5 milliseconds | Standard Deviation 12.48 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Week 6 | 1.1 milliseconds | Standard Deviation 16.84 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Day 1 (postdose) | -0.1 milliseconds | Standard Deviation 13.76 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Week 52 | -5.8 milliseconds | Standard Deviation 20.54 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Day 1 (postdose) | 0.2 milliseconds | Standard Deviation 13.91 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Week 52 | -1.6 milliseconds | Standard Deviation 16.75 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | Week 6 | 0.8 milliseconds | Standard Deviation 15.31 |
Primary
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Week 6 | -0.5 milliseconds | Standard Deviation 8.32 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Day 1 (postdose) | -2.3 milliseconds | Standard Deviation 7.32 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Week 52 | -0.2 milliseconds | Standard Deviation 6.85 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Week 6 | 1.6 milliseconds | Standard Deviation 8.96 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Day 1 (postdose) | -0.8 milliseconds | Standard Deviation 8.41 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Week 52 | 0.9 milliseconds | Standard Deviation 7.29 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Day 1 (postdose) | -1.6 milliseconds | Standard Deviation 7.87 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Week 52 | 0.3 milliseconds | Standard Deviation 7.04 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | Week 6 | 0.5 milliseconds | Standard Deviation 8.67 |
Primary
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Week 6 | 1.0 milliseconds | Standard Deviation 19.91 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Day 1 (postdose) | 1.2 milliseconds | Standard Deviation 17.96 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Week 52 | -0.1 milliseconds | Standard Deviation 20.84 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Week 6 | 0.6 milliseconds | Standard Deviation 18.34 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Day 1 (postdose) | 2.0 milliseconds | Standard Deviation 17.21 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Week 52 | 2.1 milliseconds | Standard Deviation 18.33 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Day 1 (postdose) | 1.6 milliseconds | Standard Deviation 17.58 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Week 52 | 0.9 milliseconds | Standard Deviation 19.72 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | Week 6 | 0.8 milliseconds | Standard Deviation 19.14 |
Primary
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Week 6 | 3.1 milliseconds | Standard Deviation 16.49 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Day 1 (postdose) | -1.0 milliseconds | Standard Deviation 14.03 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Week 52 | 3.4 milliseconds | Standard Deviation 18.05 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Week 6 | 2.6 milliseconds | Standard Deviation 15.63 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Day 1 (postdose) | -0.2 milliseconds | Standard Deviation 15.75 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Week 52 | 2.9 milliseconds | Standard Deviation 15.4 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Day 1 (postdose) | -0.6 milliseconds | Standard Deviation 14.84 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Week 52 | 3.2 milliseconds | Standard Deviation 16.86 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | Week 6 | 2.9 milliseconds | Standard Deviation 16.05 |
Primary
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Week 6 | 6.4 milliseconds | Standard Deviation 20.96 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Day 1 (postdose) | -5.3 milliseconds | Standard Deviation 20.72 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Week 52 | 9.8 milliseconds | Standard Deviation 24.66 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Week 6 | 6.4 milliseconds | Standard Deviation 24.61 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Day 1 (postdose) | -4.2 milliseconds | Standard Deviation 23.99 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Week 52 | 4.3 milliseconds | Standard Deviation 26.24 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Day 1 (postdose) | -4.8 milliseconds | Standard Deviation 22.27 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Week 52 | 7.3 milliseconds | Standard Deviation 25.42 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | Week 6 | 6.4 milliseconds | Standard Deviation 22.69 |
Primary
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Week 6 | 22.6 milliseconds | Standard Deviation 112.51 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Day 1 (postdose) | -30.7 milliseconds | Standard Deviation 122.48 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Week 52 | 41.8 milliseconds | Standard Deviation 122.96 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Week 6 | 26.1 milliseconds | Standard Deviation 129.35 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Day 1 (postdose) | -28.3 milliseconds | Standard Deviation 113.02 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Week 52 | 9.4 milliseconds | Standard Deviation 141.91 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Day 1 (postdose) | -29.6 milliseconds | Standard Deviation 117.9 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Week 52 | 27.5 milliseconds | Standard Deviation 132.15 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | Week 6 | 24.2 milliseconds | Standard Deviation 120.37 |
Primary
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Week 6 | -2.3 beats/minute | Standard Deviation 8.6 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Day 1 (postdose) | 2.1 beats/minute | Standard Deviation 9.51 |
| ABBV-951 Low Dose Subgroup | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Week 52 | -3.7 beats/minute | Standard Deviation 9.51 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Week 6 | -2.2 beats/minute | Standard Deviation 10.28 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Day 1 (postdose) | 2.2 beats/minute | Standard Deviation 9.76 |
| ABBV-951 High Dose Subgroup | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Week 52 | -0.7 beats/minute | Standard Deviation 11.36 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Day 1 (postdose) | 2.1 beats/minute | Standard Deviation 9.61 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Week 52 | -2.3 beats/minute | Standard Deviation 10.44 |
| ABBV-951 All Participants | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | Week 6 | -2.2 beats/minute | Standard Deviation 9.4 |
Primary
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -1.07 U/L | Standard Deviation 9.516 |
| ABBV-951 Low Dose Subgroup | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -1.47 U/L | Standard Deviation 11.487 |
| ABBV-951 Low Dose Subgroup | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -1.92 U/L | Standard Deviation 10.86 |
| ABBV-951 Low Dose Subgroup | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 1.69 U/L | Standard Deviation 23.235 |
| ABBV-951 High Dose Subgroup | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -3.09 U/L | Standard Deviation 14.538 |
| ABBV-951 High Dose Subgroup | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -3.13 U/L | Standard Deviation 9.393 |
| ABBV-951 High Dose Subgroup | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -4.67 U/L | Standard Deviation 12.516 |
| ABBV-951 High Dose Subgroup | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -5.02 U/L | Standard Deviation 15.37 |
| ABBV-951 All Participants | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.37 U/L | Standard Deviation 20.031 |
| ABBV-951 All Participants | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -3.07 U/L | Standard Deviation 13.45 |
| ABBV-951 All Participants | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -3.10 U/L | Standard Deviation 11.631 |
| ABBV-951 All Participants | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -2.06 U/L | Standard Deviation 9.489 |
Primary
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.39 mmol/L | Standard Deviation 1.186 |
| ABBV-951 Low Dose Subgroup | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.37 mmol/L | Standard Deviation 1.271 |
| ABBV-951 Low Dose Subgroup | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.33 mmol/L | Standard Deviation 1.181 |
| ABBV-951 Low Dose Subgroup | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.32 mmol/L | Standard Deviation 1.917 |
| ABBV-951 High Dose Subgroup | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.55 mmol/L | Standard Deviation 1.479 |
| ABBV-951 High Dose Subgroup | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.39 mmol/L | Standard Deviation 1.438 |
| ABBV-951 High Dose Subgroup | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.60 mmol/L | Standard Deviation 1.327 |
| ABBV-951 High Dose Subgroup | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.14 mmol/L | Standard Deviation 1.486 |
| ABBV-951 All Participants | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.42 mmol/L | Standard Deviation 1.74 |
| ABBV-951 All Participants | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.27 mmol/L | Standard Deviation 1.373 |
| ABBV-951 All Participants | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.45 mmol/L | Standard Deviation 1.249 |
| ABBV-951 All Participants | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.39 mmol/L | Standard Deviation 1.311 |
Primary
Hematocrit (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Hematocrit (Hematology): Change From Baseline to End of Study | Week 6 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.031 |
| ABBV-951 Low Dose Subgroup | Hematocrit (Hematology): Change From Baseline to End of Study | Week 39 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.028 |
| ABBV-951 Low Dose Subgroup | Hematocrit (Hematology): Change From Baseline to End of Study | Week 26 | -0.01 proportion of red blood cells in blood | Standard Deviation 0.03 |
| ABBV-951 Low Dose Subgroup | Hematocrit (Hematology): Change From Baseline to End of Study | Week 52 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.029 |
| ABBV-951 High Dose Subgroup | Hematocrit (Hematology): Change From Baseline to End of Study | Week 6 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.029 |
| ABBV-951 High Dose Subgroup | Hematocrit (Hematology): Change From Baseline to End of Study | Week 52 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.028 |
| ABBV-951 High Dose Subgroup | Hematocrit (Hematology): Change From Baseline to End of Study | Week 39 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.029 |
| ABBV-951 High Dose Subgroup | Hematocrit (Hematology): Change From Baseline to End of Study | Week 26 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.026 |
| ABBV-951 All Participants | Hematocrit (Hematology): Change From Baseline to End of Study | Week 52 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.029 |
| ABBV-951 All Participants | Hematocrit (Hematology): Change From Baseline to End of Study | Week 39 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.028 |
| ABBV-951 All Participants | Hematocrit (Hematology): Change From Baseline to End of Study | Week 26 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.028 |
| ABBV-951 All Participants | Hematocrit (Hematology): Change From Baseline to End of Study | Week 6 | -0.02 proportion of red blood cells in blood | Standard Deviation 0.03 |
Primary
Hemoglobin (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 6 | -5.00 g/L | Standard Deviation 8.308 |
| ABBV-951 Low Dose Subgroup | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 26 | -5.42 g/L | Standard Deviation 9.296 |
| ABBV-951 Low Dose Subgroup | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 39 | -5.74 g/L | Standard Deviation 8.43 |
| ABBV-951 Low Dose Subgroup | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 52 | -7.96 g/L | Standard Deviation 8.862 |
| ABBV-951 High Dose Subgroup | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 52 | -5.80 g/L | Standard Deviation 9.308 |
| ABBV-951 High Dose Subgroup | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 6 | -6.82 g/L | Standard Deviation 9.222 |
| ABBV-951 High Dose Subgroup | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 39 | -6.58 g/L | Standard Deviation 8.601 |
| ABBV-951 High Dose Subgroup | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 26 | -4.48 g/L | Standard Deviation 7.502 |
| ABBV-951 All Participants | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 52 | -6.99 g/L | Standard Deviation 9.091 |
| ABBV-951 All Participants | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 26 | -4.98 g/L | Standard Deviation 8.482 |
| ABBV-951 All Participants | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 39 | -6.11 g/L | Standard Deviation 8.48 |
| ABBV-951 All Participants | Hemoglobin (Hematology): Change From Baseline to End of Study | Week 6 | -5.89 g/L | Standard Deviation 8.789 |
Primary
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 4.22 µmol/L | Standard Deviation 7.549 |
| ABBV-951 Low Dose Subgroup | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 3.07 µmol/L | Standard Deviation 5.301 |
| ABBV-951 Low Dose Subgroup | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 4.88 µmol/L | Standard Deviation 6.103 |
| ABBV-951 High Dose Subgroup | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 6.69 µmol/L | Standard Deviation 6.306 |
| ABBV-951 High Dose Subgroup | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 6.70 µmol/L | Standard Deviation 11.04 |
| ABBV-951 High Dose Subgroup | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 7.24 µmol/L | Standard Deviation 8.687 |
| ABBV-951 All Participants | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 4.79 µmol/L | Standard Deviation 8.692 |
| ABBV-951 All Participants | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 5.86 µmol/L | Standard Deviation 7.351 |
| ABBV-951 All Participants | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 5.32 µmol/L | Standard Deviation 7.106 |
Primary
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 0.08 mmol/L | Standard Deviation 0.173 |
| ABBV-951 Low Dose Subgroup | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.09 mmol/L | Standard Deviation 0.182 |
| ABBV-951 Low Dose Subgroup | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.07 mmol/L | Standard Deviation 0.165 |
| ABBV-951 Low Dose Subgroup | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.09 mmol/L | Standard Deviation 0.169 |
| ABBV-951 High Dose Subgroup | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.08 mmol/L | Standard Deviation 0.172 |
| ABBV-951 High Dose Subgroup | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 0.08 mmol/L | Standard Deviation 0.168 |
| ABBV-951 High Dose Subgroup | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.08 mmol/L | Standard Deviation 0.155 |
| ABBV-951 High Dose Subgroup | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.09 mmol/L | Standard Deviation 0.17 |
| ABBV-951 All Participants | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.08 mmol/L | Standard Deviation 0.17 |
| ABBV-951 All Participants | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.09 mmol/L | Standard Deviation 0.176 |
| ABBV-951 All Participants | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.08 mmol/L | Standard Deviation 0.16 |
| ABBV-951 All Participants | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 0.08 mmol/L | Standard Deviation 0.17 |
Primary
Lymphocytes (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 6 | 0.06 cells*10^9/L | Standard Deviation 0.305 |
| ABBV-951 Low Dose Subgroup | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 26 | 0.09 cells*10^9/L | Standard Deviation 0.331 |
| ABBV-951 Low Dose Subgroup | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 39 | 0.03 cells*10^9/L | Standard Deviation 0.394 |
| ABBV-951 Low Dose Subgroup | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 52 | 0.04 cells*10^9/L | Standard Deviation 0.394 |
| ABBV-951 High Dose Subgroup | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 52 | -0.05 cells*10^9/L | Standard Deviation 0.294 |
| ABBV-951 High Dose Subgroup | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 6 | -0.07 cells*10^9/L | Standard Deviation 0.326 |
| ABBV-951 High Dose Subgroup | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 39 | 0.04 cells*10^9/L | Standard Deviation 0.312 |
| ABBV-951 High Dose Subgroup | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 26 | 13.92 cells*10^9/L | Standard Deviation 110.588 |
| ABBV-951 All Participants | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 52 | 0.00 cells*10^9/L | Standard Deviation 0.354 |
| ABBV-951 All Participants | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 26 | 6.59 cells*10^9/L | Standard Deviation 75.823 |
| ABBV-951 All Participants | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 39 | 0.03 cells*10^9/L | Standard Deviation 0.359 |
| ABBV-951 All Participants | Lymphocytes (Hematology): Change From Baseline to End of Study | Week 6 | 0.00 cells*10^9/L | Standard Deviation 0.321 |
Primary
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.03 mmol/L | Standard Deviation 0.067 |
| ABBV-951 Low Dose Subgroup | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.03 mmol/L | Standard Deviation 0.064 |
| ABBV-951 Low Dose Subgroup | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.02 mmol/L | Standard Deviation 0.076 |
| ABBV-951 Low Dose Subgroup | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.03 mmol/L | Standard Deviation 0.078 |
| ABBV-951 High Dose Subgroup | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.01 mmol/L | Standard Deviation 0.057 |
| ABBV-951 High Dose Subgroup | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.03 mmol/L | Standard Deviation 0.058 |
| ABBV-951 High Dose Subgroup | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.01 mmol/L | Standard Deviation 0.073 |
| ABBV-951 High Dose Subgroup | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.02 mmol/L | Standard Deviation 0.062 |
| ABBV-951 All Participants | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.02 mmol/L | Standard Deviation 0.07 |
| ABBV-951 All Participants | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.02 mmol/L | Standard Deviation 0.063 |
| ABBV-951 All Participants | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.02 mmol/L | Standard Deviation 0.075 |
| ABBV-951 All Participants | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.03 mmol/L | Standard Deviation 0.063 |
Primary
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 6 | -0.09 picograms | Standard Deviation 0.822 |
| ABBV-951 Low Dose Subgroup | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 26 | -0.38 picograms | Standard Deviation 1.033 |
| ABBV-951 Low Dose Subgroup | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 39 | -0.34 picograms | Standard Deviation 1.205 |
| ABBV-951 Low Dose Subgroup | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 52 | -0.36 picograms | Standard Deviation 1.124 |
| ABBV-951 High Dose Subgroup | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 52 | -0.07 picograms | Standard Deviation 1.142 |
| ABBV-951 High Dose Subgroup | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 6 | -0.15 picograms | Standard Deviation 0.825 |
| ABBV-951 High Dose Subgroup | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 39 | -0.08 picograms | Standard Deviation 0.978 |
| ABBV-951 High Dose Subgroup | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 26 | 0.05 picograms | Standard Deviation 1.078 |
| ABBV-951 All Participants | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 52 | -0.23 picograms | Standard Deviation 1.137 |
| ABBV-951 All Participants | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 26 | -0.18 picograms | Standard Deviation 1.072 |
| ABBV-951 All Participants | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 39 | -0.22 picograms | Standard Deviation 1.114 |
| ABBV-951 All Participants | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Week 6 | -0.12 picograms | Standard Deviation 0.821 |
Primary
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 6 | 2.15 g/L | Standard Deviation 11.689 |
| ABBV-951 Low Dose Subgroup | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 26 | -1.30 g/L | Standard Deviation 14.844 |
| ABBV-951 Low Dose Subgroup | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 39 | -2.13 g/L | Standard Deviation 13.677 |
| ABBV-951 Low Dose Subgroup | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 52 | -0.16 g/L | Standard Deviation 12.609 |
| ABBV-951 High Dose Subgroup | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 52 | 0.18 g/L | Standard Deviation 13.684 |
| ABBV-951 High Dose Subgroup | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 6 | 1.78 g/L | Standard Deviation 10.87 |
| ABBV-951 High Dose Subgroup | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 39 | -2.64 g/L | Standard Deviation 14.826 |
| ABBV-951 High Dose Subgroup | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 26 | 2.17 g/L | Standard Deviation 15.741 |
| ABBV-951 All Participants | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 52 | 0.00 g/L | Standard Deviation 13.074 |
| ABBV-951 All Participants | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 26 | 0.31 g/L | Standard Deviation 15.306 |
| ABBV-951 All Participants | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 39 | -2.37 g/L | Standard Deviation 14.161 |
| ABBV-951 All Participants | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Week 6 | 1.97 g/L | Standard Deviation 11.264 |
Primary
Monocytes (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Monocytes (Hematology): Change From Baseline to End of Study | Week 6 | 0.01 cells*10^9/L | Standard Deviation 0.127 |
| ABBV-951 Low Dose Subgroup | Monocytes (Hematology): Change From Baseline to End of Study | Week 26 | 0.02 cells*10^9/L | Standard Deviation 0.095 |
| ABBV-951 Low Dose Subgroup | Monocytes (Hematology): Change From Baseline to End of Study | Week 39 | 0.02 cells*10^9/L | Standard Deviation 0.12 |
| ABBV-951 Low Dose Subgroup | Monocytes (Hematology): Change From Baseline to End of Study | Week 52 | 0.00 cells*10^9/L | Standard Deviation 0.109 |
| ABBV-951 High Dose Subgroup | Monocytes (Hematology): Change From Baseline to End of Study | Week 52 | 0.01 cells*10^9/L | Standard Deviation 0.132 |
| ABBV-951 High Dose Subgroup | Monocytes (Hematology): Change From Baseline to End of Study | Week 6 | 0.01 cells*10^9/L | Standard Deviation 0.123 |
| ABBV-951 High Dose Subgroup | Monocytes (Hematology): Change From Baseline to End of Study | Week 39 | 0.03 cells*10^9/L | Standard Deviation 0.122 |
| ABBV-951 High Dose Subgroup | Monocytes (Hematology): Change From Baseline to End of Study | Week 26 | 17.43 cells*10^9/L | Standard Deviation 138.498 |
| ABBV-951 All Participants | Monocytes (Hematology): Change From Baseline to End of Study | Week 52 | 0.00 cells*10^9/L | Standard Deviation 0.119 |
| ABBV-951 All Participants | Monocytes (Hematology): Change From Baseline to End of Study | Week 26 | 8.21 cells*10^9/L | Standard Deviation 94.963 |
| ABBV-951 All Participants | Monocytes (Hematology): Change From Baseline to End of Study | Week 39 | 0.02 cells*10^9/L | Standard Deviation 0.12 |
| ABBV-951 All Participants | Monocytes (Hematology): Change From Baseline to End of Study | Week 6 | 0.01 cells*10^9/L | Standard Deviation 0.125 |
Primary
Neutrophils (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Neutrophils (Hematology): Change From Baseline to End of Study | Week 6 | 0.01 cells*10^9/L | Standard Deviation 1.72 |
| ABBV-951 Low Dose Subgroup | Neutrophils (Hematology): Change From Baseline to End of Study | Week 26 | -0.03 cells*10^9/L | Standard Deviation 1.813 |
| ABBV-951 Low Dose Subgroup | Neutrophils (Hematology): Change From Baseline to End of Study | Week 39 | -0.23 cells*10^9/L | Standard Deviation 2.38 |
| ABBV-951 Low Dose Subgroup | Neutrophils (Hematology): Change From Baseline to End of Study | Week 52 | -0.14 cells*10^9/L | Standard Deviation 1.986 |
| ABBV-951 High Dose Subgroup | Neutrophils (Hematology): Change From Baseline to End of Study | Week 52 | -0.04 cells*10^9/L | Standard Deviation 1.498 |
| ABBV-951 High Dose Subgroup | Neutrophils (Hematology): Change From Baseline to End of Study | Week 6 | 0.33 cells*10^9/L | Standard Deviation 2.102 |
| ABBV-951 High Dose Subgroup | Neutrophils (Hematology): Change From Baseline to End of Study | Week 39 | 0.18 cells*10^9/L | Standard Deviation 1.635 |
| ABBV-951 High Dose Subgroup | Neutrophils (Hematology): Change From Baseline to End of Study | Week 26 | 143.08 cells*10^9/L | Standard Deviation 1133.988 |
| ABBV-951 All Participants | Neutrophils (Hematology): Change From Baseline to End of Study | Week 52 | -0.10 cells*10^9/L | Standard Deviation 1.778 |
| ABBV-951 All Participants | Neutrophils (Hematology): Change From Baseline to End of Study | Week 26 | 67.25 cells*10^9/L | Standard Deviation 777.558 |
| ABBV-951 All Participants | Neutrophils (Hematology): Change From Baseline to End of Study | Week 39 | -0.05 cells*10^9/L | Standard Deviation 2.089 |
| ABBV-951 All Participants | Neutrophils (Hematology): Change From Baseline to End of Study | Week 6 | 0.17 cells*10^9/L | Standard Deviation 1.917 |
Primary
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time frame: From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events | Any TEAE | 121 Participants |
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events | TESAE | 32 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events | Any TEAE | 109 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events | TESAE | 31 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events | Any TEAE | 230 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events | TESAE | 63 Participants |
Primary
Number of Participants With Adverse Events of Special Interest
Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.
Time frame: From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Infusion site reactions | 103 Participants |
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Polyneuropathy (peripheral neuropathy) | 14 Participants |
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Falls and associated injuries | 37 Participants |
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Infusion site infections | 42 Participants |
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Somnolence | 9 Participants |
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Weight loss | 12 Participants |
| ABBV-951 Low Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Hallucinations/psychosis | 32 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Falls and associated injuries | 37 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Infusion site infections | 44 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Infusion site reactions | 97 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Hallucinations/psychosis | 29 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Polyneuropathy (peripheral neuropathy) | 13 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Weight loss | 15 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Adverse Events of Special Interest | Somnolence | 3 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events of Special Interest | Polyneuropathy (peripheral neuropathy) | 27 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events of Special Interest | Infusion site reactions | 200 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events of Special Interest | Somnolence | 12 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events of Special Interest | Weight loss | 27 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events of Special Interest | Falls and associated injuries | 74 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events of Special Interest | Hallucinations/psychosis | 61 Participants |
| ABBV-951 All Participants | Number of Participants With Adverse Events of Special Interest | Infusion site infections | 86 Participants |
Primary
Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale
Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria \> 2 or \> C was recorded as an adverse event (AE).
Time frame: Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABBV-951 Low Dose Subgroup | Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale | 10 Participants |
| ABBV-951 High Dose Subgroup | Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale | 15 Participants |
| ABBV-951 All Participants | Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale | 25 Participants |
Primary
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Time frame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | -1.9 mmHg | Standard Deviation 10.61 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | 0.0 mmHg | Standard Deviation 10.91 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | -1.7 mmHg | Standard Deviation 12.99 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | -1.5 mmHg | Standard Deviation 10.44 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -2.6 mmHg | Standard Deviation 12 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -0.8 mmHg | Standard Deviation 12.27 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -4.0 mmHg | Standard Deviation 12.2 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- standing | -1.7 mmHg | Standard Deviation 12.55 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -1.1 mmHg | Standard Deviation 12.46 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -1.4 mmHg | Standard Deviation 12.06 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 13- supine | -2.6 mmHg | Standard Deviation 12.52 |
| ABBV-951 Low Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 39- supine | 0.2 mmHg | Standard Deviation 12.16 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 39- supine | 0.2 mmHg | Standard Deviation 12.77 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | -0.7 mmHg | Standard Deviation 13.27 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -1.2 mmHg | Standard Deviation 14.67 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -1.3 mmHg | Standard Deviation 13.46 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | -0.6 mmHg | Standard Deviation 10 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -2.2 mmHg | Standard Deviation 14.76 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 13- supine | -0.5 mmHg | Standard Deviation 9.59 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | 0.3 mmHg | Standard Deviation 10.16 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- standing | 1.1 mmHg | Standard Deviation 12.01 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -2.1 mmHg | Standard Deviation 13.87 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | 0.8 mmHg | Standard Deviation 11.42 |
| ABBV-951 High Dose Subgroup | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -2.1 mmHg | Standard Deviation 12.8 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | -0.4 mmHg | Standard Deviation 10.91 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -2.4 mmHg | Standard Deviation 12.88 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -1.7 mmHg | Standard Deviation 12.38 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -1.5 mmHg | Standard Deviation 13.5 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -2.7 mmHg | Standard Deviation 13.42 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- standing | -0.4 mmHg | Standard Deviation 12.34 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 13- supine | -1.8 mmHg | Standard Deviation 11.46 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | -1.3 mmHg | Standard Deviation 11.92 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | -0.3 mmHg | Standard Deviation 10.46 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -1.2 mmHg | Standard Deviation 12.91 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | -0.7 mmHg | Standard Deviation 11.75 |
| ABBV-951 All Participants | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 39- supine | 0.2 mmHg | Standard Deviation 12.4 |
Primary
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Time frame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | -1.5 beats/minute | Standard Deviation 8.49 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | -0.5 beats/minute | Standard Deviation 10.86 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | -0.9 beats/minute | Standard Deviation 8.9 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | 0.5 beats/minute | Standard Deviation 9.72 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -5.1 beats/minute | Standard Deviation 11.43 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -3.1 beats/minute | Standard Deviation 12.45 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -2.9 beats/minute | Standard Deviation 12.29 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 52- standing | -3.8 beats/minute | Standard Deviation 12.88 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -3.3 beats/minute | Standard Deviation 10.05 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -2.6 beats/minute | Standard Deviation 10.06 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 13- supine | 1.1 beats/minute | Standard Deviation 11.72 |
| ABBV-951 Low Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 39- supine | -3.7 beats/minute | Standard Deviation 11.76 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 39- supine | -3.2 beats/minute | Standard Deviation 11.16 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | -1.8 beats/minute | Standard Deviation 10.49 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -2.4 beats/minute | Standard Deviation 12.43 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -0.6 beats/minute | Standard Deviation 11.1 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | 0.2 beats/minute | Standard Deviation 10.16 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -3.0 beats/minute | Standard Deviation 12.23 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 13- supine | -4.8 beats/minute | Standard Deviation 7.6 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | 0.3 beats/minute | Standard Deviation 9.32 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 52- standing | -4.3 beats/minute | Standard Deviation 11.56 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -2.6 beats/minute | Standard Deviation 12.5 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | -0.5 beats/minute | Standard Deviation 8.55 |
| ABBV-951 High Dose Subgroup | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -3.3 beats/minute | Standard Deviation 12.6 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | 0.0 beats/minute | Standard Deviation 9.19 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -3.9 beats/minute | Standard Deviation 11.98 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -3.0 beats/minute | Standard Deviation 11.31 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -3.1 beats/minute | Standard Deviation 12.31 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -2.7 beats/minute | Standard Deviation 12.31 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 52- standing | -4.0 beats/minute | Standard Deviation 12.27 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 13- supine | -1.1 beats/minute | Standard Deviation 10.68 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | -1.6 beats/minute | Standard Deviation 9.46 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | -0.1 beats/minute | Standard Deviation 10.51 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -2.0 beats/minute | Standard Deviation 10.62 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | -0.4 beats/minute | Standard Deviation 9.08 |
| ABBV-951 All Participants | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Week 39- supine | -3.4 beats/minute | Standard Deviation 11.45 |
Primary
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Time frame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | -1.5 mmHg | Standard Deviation 12 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | -1.5 mmHg | Standard Deviation 11.85 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | -2.4 mmHg | Standard Deviation 16.25 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | -1.3 mmHg | Standard Deviation 14.59 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -2.3 mmHg | Standard Deviation 17.05 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -2.9 mmHg | Standard Deviation 18.32 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -4.7 mmHg | Standard Deviation 19.23 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- standing | -3.9 mmHg | Standard Deviation 19.81 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -1.0 mmHg | Standard Deviation 16.75 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -1.2 mmHg | Standard Deviation 16.67 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 13- supine | -4.0 mmHg | Standard Deviation 18.34 |
| ABBV-951 Low Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 39- supine | -1.7 mmHg | Standard Deviation 19.12 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 39- supine | -1.8 mmHg | Standard Deviation 22.08 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | 3.5 mmHg | Standard Deviation 16.01 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -4.0 mmHg | Standard Deviation 21.01 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -4.5 mmHg | Standard Deviation 21.94 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | 2.6 mmHg | Standard Deviation 17.33 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -3.1 mmHg | Standard Deviation 25.89 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 13- supine | -1.8 mmHg | Standard Deviation 24.89 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | -0.3 mmHg | Standard Deviation 14.38 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- standing | -1.5 mmHg | Standard Deviation 20.91 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -1.3 mmHg | Standard Deviation 25.5 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | 0.7 mmHg | Standard Deviation 13.75 |
| ABBV-951 High Dose Subgroup | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -6.7 mmHg | Standard Deviation 22.99 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- orthostatic | -0.4 mmHg | Standard Deviation 14.19 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- standing | -1.9 mmHg | Standard Deviation 21.35 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 4- supine | -3.8 mmHg | Standard Deviation 20.05 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- standing | -3.0 mmHg | Standard Deviation 22.19 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- standing | -4.4 mmHg | Standard Deviation 20 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 52- standing | -2.8 mmHg | Standard Deviation 20.26 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 13- supine | -3.2 mmHg | Standard Deviation 20.75 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 1- orthostatic | 0.9 mmHg | Standard Deviation 14.22 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 6- orthostatic | 0.5 mmHg | Standard Deviation 14.83 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 2- supine | -2.7 mmHg | Standard Deviation 19.42 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 26- orthostatic | -1.4 mmHg | Standard Deviation 15.38 |
| ABBV-951 All Participants | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Week 39- supine | -1.7 mmHg | Standard Deviation 20.47 |
Primary
pH (Urinalysis): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | pH (Urinalysis): Change From Baseline to End of Study | Week 6 | 0.07 no units | Standard Deviation 0.601 |
| ABBV-951 Low Dose Subgroup | pH (Urinalysis): Change From Baseline to End of Study | Week 26 | 0.20 no units | Standard Deviation 0.537 |
| ABBV-951 Low Dose Subgroup | pH (Urinalysis): Change From Baseline to End of Study | Week 39 | 0.13 no units | Standard Deviation 0.566 |
| ABBV-951 Low Dose Subgroup | pH (Urinalysis): Change From Baseline to End of Study | Week 52 | 0.18 no units | Standard Deviation 0.682 |
| ABBV-951 High Dose Subgroup | pH (Urinalysis): Change From Baseline to End of Study | Week 52 | 0.20 no units | Standard Deviation 0.537 |
| ABBV-951 High Dose Subgroup | pH (Urinalysis): Change From Baseline to End of Study | Week 6 | 0.19 no units | Standard Deviation 0.575 |
| ABBV-951 High Dose Subgroup | pH (Urinalysis): Change From Baseline to End of Study | Week 39 | 0.31 no units | Standard Deviation 0.617 |
| ABBV-951 High Dose Subgroup | pH (Urinalysis): Change From Baseline to End of Study | Week 26 | 0.24 no units | Standard Deviation 0.56 |
| ABBV-951 All Participants | pH (Urinalysis): Change From Baseline to End of Study | Week 52 | 0.19 no units | Standard Deviation 0.62 |
| ABBV-951 All Participants | pH (Urinalysis): Change From Baseline to End of Study | Week 26 | 0.22 no units | Standard Deviation 0.546 |
| ABBV-951 All Participants | pH (Urinalysis): Change From Baseline to End of Study | Week 39 | 0.21 no units | Standard Deviation 0.594 |
| ABBV-951 All Participants | pH (Urinalysis): Change From Baseline to End of Study | Week 6 | 0.13 no units | Standard Deviation 0.59 |
Primary
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.02 mmol/L | Standard Deviation 0.335 |
| ABBV-951 Low Dose Subgroup | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.01 mmol/L | Standard Deviation 0.367 |
| ABBV-951 Low Dose Subgroup | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.01 mmol/L | Standard Deviation 0.389 |
| ABBV-951 Low Dose Subgroup | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.10 mmol/L | Standard Deviation 0.369 |
| ABBV-951 High Dose Subgroup | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.03 mmol/L | Standard Deviation 0.338 |
| ABBV-951 High Dose Subgroup | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.08 mmol/L | Standard Deviation 0.33 |
| ABBV-951 High Dose Subgroup | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.09 mmol/L | Standard Deviation 0.382 |
| ABBV-951 High Dose Subgroup | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.00 mmol/L | Standard Deviation 0.373 |
| ABBV-951 All Participants | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.07 mmol/L | Standard Deviation 0.357 |
| ABBV-951 All Participants | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.00 mmol/L | Standard Deviation 0.368 |
| ABBV-951 All Participants | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.04 mmol/L | Standard Deviation 0.387 |
| ABBV-951 All Participants | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.05 mmol/L | Standard Deviation 0.333 |
Primary
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 6 | 0.03 seconds | Standard Deviation 0.48 |
| ABBV-951 Low Dose Subgroup | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 26 | -0.08 seconds | Standard Deviation 1.026 |
| ABBV-951 Low Dose Subgroup | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 39 | 0.10 seconds | Standard Deviation 0.569 |
| ABBV-951 Low Dose Subgroup | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 52 | 0.10 seconds | Standard Deviation 0.889 |
| ABBV-951 High Dose Subgroup | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 52 | -0.22 seconds | Standard Deviation 3.703 |
| ABBV-951 High Dose Subgroup | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 6 | -0.09 seconds | Standard Deviation 2.556 |
| ABBV-951 High Dose Subgroup | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 39 | -0.21 seconds | Standard Deviation 3.396 |
| ABBV-951 High Dose Subgroup | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 26 | -0.36 seconds | Standard Deviation 3.187 |
| ABBV-951 All Participants | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 52 | -0.04 seconds | Standard Deviation 2.483 |
| ABBV-951 All Participants | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 26 | -0.20 seconds | Standard Deviation 2.261 |
| ABBV-951 All Participants | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 39 | -0.03 seconds | Standard Deviation 2.239 |
| ABBV-951 All Participants | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Week 6 | -0.03 seconds | Standard Deviation 1.803 |
Primary
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 52 | -0.21 cells*10^12/L | Standard Deviation 0.291 |
| ABBV-951 Low Dose Subgroup | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 6 | -0.15 cells*10^12/L | Standard Deviation 0.261 |
| ABBV-951 Low Dose Subgroup | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 39 | -0.14 cells*10^12/L | Standard Deviation 0.271 |
| ABBV-951 Low Dose Subgroup | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 26 | -0.12 cells*10^12/L | Standard Deviation 0.295 |
| ABBV-951 High Dose Subgroup | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 39 | -0.19 cells*10^12/L | Standard Deviation 0.29 |
| ABBV-951 High Dose Subgroup | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 52 | -0.16 cells*10^12/L | Standard Deviation 0.293 |
| ABBV-951 High Dose Subgroup | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 26 | -0.13 cells*10^12/L | Standard Deviation 0.273 |
| ABBV-951 High Dose Subgroup | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 6 | -0.21 cells*10^12/L | Standard Deviation 0.296 |
| ABBV-951 All Participants | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 52 | -0.19 cells*10^12/L | Standard Deviation 0.292 |
| ABBV-951 All Participants | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 26 | -0.13 cells*10^12/L | Standard Deviation 0.284 |
| ABBV-951 All Participants | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 39 | -0.17 cells*10^12/L | Standard Deviation 0.279 |
| ABBV-951 All Participants | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Week 6 | -0.18 cells*10^12/L | Standard Deviation 0.28 |
Primary
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -8.94 U/L | Standard Deviation 8.928 |
| ABBV-951 Low Dose Subgroup | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -8.95 U/L | Standard Deviation 9.869 |
| ABBV-951 Low Dose Subgroup | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -9.70 U/L | Standard Deviation 9.145 |
| ABBV-951 Low Dose Subgroup | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -9.37 U/L | Standard Deviation 10.347 |
| ABBV-951 High Dose Subgroup | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -12.11 U/L | Standard Deviation 9.947 |
| ABBV-951 High Dose Subgroup | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -11.28 U/L | Standard Deviation 10.053 |
| ABBV-951 High Dose Subgroup | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -10.09 U/L | Standard Deviation 13.476 |
| ABBV-951 High Dose Subgroup | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -11.66 U/L | Standard Deviation 11.294 |
| ABBV-951 All Participants | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -10.56 U/L | Standard Deviation 10.227 |
| ABBV-951 All Participants | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -10.16 U/L | Standard Deviation 10.579 |
| ABBV-951 All Participants | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -9.87 U/L | Standard Deviation 11.175 |
| ABBV-951 All Participants | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -10.07 U/L | Standard Deviation 9.535 |
Primary
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -1.89 U/L | Standard Deviation 4.881 |
| ABBV-951 Low Dose Subgroup | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.69 U/L | Standard Deviation 8.569 |
| ABBV-951 Low Dose Subgroup | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -1.38 U/L | Standard Deviation 6.714 |
| ABBV-951 Low Dose Subgroup | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.81 U/L | Standard Deviation 6.576 |
| ABBV-951 High Dose Subgroup | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.82 U/L | Standard Deviation 7.794 |
| ABBV-951 High Dose Subgroup | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -2.21 U/L | Standard Deviation 6.163 |
| ABBV-951 High Dose Subgroup | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -1.17 U/L | Standard Deviation 7.036 |
| ABBV-951 High Dose Subgroup | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -2.56 U/L | Standard Deviation 7.013 |
| ABBV-951 All Participants | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.81 U/L | Standard Deviation 7.095 |
| ABBV-951 All Participants | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -1.52 U/L | Standard Deviation 7.943 |
| ABBV-951 All Participants | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -1.29 U/L | Standard Deviation 6.827 |
| ABBV-951 All Participants | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -2.05 U/L | Standard Deviation 5.524 |
Primary
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -6.57 U/L | Standard Deviation 26.734 |
| ABBV-951 Low Dose Subgroup | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -1.66 U/L | Standard Deviation 23.894 |
| ABBV-951 Low Dose Subgroup | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -2.17 U/L | Standard Deviation 25.01 |
| ABBV-951 Low Dose Subgroup | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.14 U/L | Standard Deviation 22.788 |
| ABBV-951 High Dose Subgroup | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 3.32 U/L | Standard Deviation 26.413 |
| ABBV-951 High Dose Subgroup | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -8.58 U/L | Standard Deviation 23.626 |
| ABBV-951 High Dose Subgroup | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -2.02 U/L | Standard Deviation 26.431 |
| ABBV-951 High Dose Subgroup | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -4.91 U/L | Standard Deviation 23.613 |
| ABBV-951 All Participants | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 1.41 U/L | Standard Deviation 24.237 |
| ABBV-951 All Participants | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -3.14 U/L | Standard Deviation 23.725 |
| ABBV-951 All Participants | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -2.10 U/L | Standard Deviation 25.526 |
| ABBV-951 All Participants | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -7.55 U/L | Standard Deviation 25.213 |
Primary
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 1.19 mmol/L | Standard Deviation 2.372 |
| ABBV-951 Low Dose Subgroup | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.77 mmol/L | Standard Deviation 2.418 |
| ABBV-951 Low Dose Subgroup | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.90 mmol/L | Standard Deviation 2.24 |
| ABBV-951 Low Dose Subgroup | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.78 mmol/L | Standard Deviation 2.374 |
| ABBV-951 High Dose Subgroup | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.57 mmol/L | Standard Deviation 2.304 |
| ABBV-951 High Dose Subgroup | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 0.97 mmol/L | Standard Deviation 2.518 |
| ABBV-951 High Dose Subgroup | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.63 mmol/L | Standard Deviation 2.874 |
| ABBV-951 High Dose Subgroup | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.28 mmol/L | Standard Deviation 2.744 |
| ABBV-951 All Participants | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 0.69 mmol/L | Standard Deviation 2.337 |
| ABBV-951 All Participants | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.55 mmol/L | Standard Deviation 2.574 |
| ABBV-951 All Participants | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.78 mmol/L | Standard Deviation 2.522 |
| ABBV-951 All Participants | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 1.09 mmol/L | Standard Deviation 2.44 |
Primary
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.52 mmol/L | Standard Deviation 3.168 |
| ABBV-951 Low Dose Subgroup | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.35 mmol/L | Standard Deviation 3.173 |
| ABBV-951 Low Dose Subgroup | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.90 mmol/L | Standard Deviation 2.984 |
| ABBV-951 Low Dose Subgroup | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.55 mmol/L | Standard Deviation 2.774 |
| ABBV-951 High Dose Subgroup | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.84 mmol/L | Standard Deviation 2.164 |
| ABBV-951 High Dose Subgroup | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -1.06 mmol/L | Standard Deviation 2.592 |
| ABBV-951 High Dose Subgroup | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.68 mmol/L | Standard Deviation 2.772 |
| ABBV-951 High Dose Subgroup | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -1.26 mmol/L | Standard Deviation 2.744 |
| ABBV-951 All Participants | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.67 mmol/L | Standard Deviation 2.522 |
| ABBV-951 All Participants | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.76 mmol/L | Standard Deviation 3.01 |
| ABBV-951 All Participants | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.81 mmol/L | Standard Deviation 2.887 |
| ABBV-951 All Participants | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.78 mmol/L | Standard Deviation 2.911 |
Primary
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 26 | 0.00 No units | Standard Deviation 0.009 |
| ABBV-951 Low Dose Subgroup | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 6 | 0.00 No units | Standard Deviation 0.009 |
| ABBV-951 Low Dose Subgroup | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 39 | 0.00 No units | Standard Deviation 0.009 |
| ABBV-951 Low Dose Subgroup | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 52 | 0.00 No units | Standard Deviation 0.01 |
| ABBV-951 High Dose Subgroup | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 52 | 0.00 No units | Standard Deviation 0.009 |
| ABBV-951 High Dose Subgroup | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 39 | 0.00 No units | Standard Deviation 0.009 |
| ABBV-951 High Dose Subgroup | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 6 | 0.00 No units | Standard Deviation 0.007 |
| ABBV-951 High Dose Subgroup | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 26 | 0.00 No units | Standard Deviation 0.009 |
| ABBV-951 All Participants | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 6 | 0.00 No units | Standard Deviation 0.008 |
| ABBV-951 All Participants | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 26 | 0.00 No units | Standard Deviation 0.009 |
| ABBV-951 All Participants | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 39 | 0.00 No units | Standard Deviation 0.009 |
| ABBV-951 All Participants | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Week 52 | 0.00 No units | Standard Deviation 0.009 |
Primary
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.85 µmol/L | Standard Deviation 3.42 |
| ABBV-951 Low Dose Subgroup | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.43 µmol/L | Standard Deviation 3.535 |
| ABBV-951 Low Dose Subgroup | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.71 µmol/L | Standard Deviation 2.881 |
| ABBV-951 Low Dose Subgroup | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.30 µmol/L | Standard Deviation 3.673 |
| ABBV-951 High Dose Subgroup | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.15 µmol/L | Standard Deviation 3.25 |
| ABBV-951 High Dose Subgroup | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.15 µmol/L | Standard Deviation 3.167 |
| ABBV-951 High Dose Subgroup | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | 0.31 µmol/L | Standard Deviation 3.754 |
| ABBV-951 High Dose Subgroup | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 0.28 µmol/L | Standard Deviation 2.814 |
| ABBV-951 All Participants | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.24 µmol/L | Standard Deviation 3.485 |
| ABBV-951 All Participants | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.11 µmol/L | Standard Deviation 3.24 |
| ABBV-951 All Participants | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.27 µmol/L | Standard Deviation 3.313 |
| ABBV-951 All Participants | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.51 µmol/L | Standard Deviation 3.311 |
Primary
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.37 mmol/L | Standard Deviation 0.688 |
| ABBV-951 Low Dose Subgroup | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.19 mmol/L | Standard Deviation 0.657 |
| ABBV-951 Low Dose Subgroup | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.33 mmol/L | Standard Deviation 0.565 |
| ABBV-951 Low Dose Subgroup | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.31 mmol/L | Standard Deviation 0.66 |
| ABBV-951 High Dose Subgroup | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.25 mmol/L | Standard Deviation 0.594 |
| ABBV-951 High Dose Subgroup | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.57 mmol/L | Standard Deviation 0.556 |
| ABBV-951 High Dose Subgroup | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.41 mmol/L | Standard Deviation 0.552 |
| ABBV-951 High Dose Subgroup | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.31 mmol/L | Standard Deviation 0.661 |
| ABBV-951 All Participants | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.29 mmol/L | Standard Deviation 0.63 |
| ABBV-951 All Participants | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -0.25 mmol/L | Standard Deviation 0.659 |
| ABBV-951 All Participants | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -0.36 mmol/L | Standard Deviation 0.559 |
| ABBV-951 All Participants | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -0.47 mmol/L | Standard Deviation 0.634 |
Primary
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -28.36 µmol/L | Standard Deviation 51.219 |
| ABBV-951 Low Dose Subgroup | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -16.66 µmol/L | Standard Deviation 60.922 |
| ABBV-951 Low Dose Subgroup | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -13.55 µmol/L | Standard Deviation 57.83 |
| ABBV-951 Low Dose Subgroup | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -15.27 µmol/L | Standard Deviation 56.459 |
| ABBV-951 High Dose Subgroup | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -31.23 µmol/L | Standard Deviation 29.78 |
| ABBV-951 High Dose Subgroup | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -37.43 µmol/L | Standard Deviation 37.302 |
| ABBV-951 High Dose Subgroup | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -35.80 µmol/L | Standard Deviation 40.965 |
| ABBV-951 High Dose Subgroup | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -32.91 µmol/L | Standard Deviation 34.446 |
| ABBV-951 All Participants | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -22.15 µmol/L | Standard Deviation 47.38 |
| ABBV-951 All Participants | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -24.01 µmol/L | Standard Deviation 51.163 |
| ABBV-951 All Participants | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 39 | -23.18 µmol/L | Standard Deviation 52.213 |
| ABBV-951 All Participants | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -32.73 µmol/L | Standard Deviation 45.163 |
Primary
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -147.38 pmol/L | Standard Deviation 845.662 |
| ABBV-951 Low Dose Subgroup | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -229.58 pmol/L | Standard Deviation 1349.008 |
| ABBV-951 Low Dose Subgroup | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -268.44 pmol/L | Standard Deviation 1684.785 |
| ABBV-951 High Dose Subgroup | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -143.30 pmol/L | Standard Deviation 1033.488 |
| ABBV-951 High Dose Subgroup | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -206.30 pmol/L | Standard Deviation 2217.016 |
| ABBV-951 High Dose Subgroup | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -212.84 pmol/L | Standard Deviation 1096.656 |
| ABBV-951 All Participants | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | -218.53 pmol/L | Standard Deviation 1808.859 |
| ABBV-951 All Participants | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -244.98 pmol/L | Standard Deviation 1460.902 |
| ABBV-951 All Participants | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -145.53 pmol/L | Standard Deviation 931.955 |
Primary
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | -4.50 nmol/L | Standard Deviation 89.013 |
| ABBV-951 Low Dose Subgroup | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 0.30 nmol/L | Standard Deviation 129.306 |
| ABBV-951 Low Dose Subgroup | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | -0.32 nmol/L | Standard Deviation 124.059 |
| ABBV-951 High Dose Subgroup | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 14.10 nmol/L | Standard Deviation 103.462 |
| ABBV-951 High Dose Subgroup | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 4.68 nmol/L | Standard Deviation 87.199 |
| ABBV-951 High Dose Subgroup | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 44.30 nmol/L | Standard Deviation 124.456 |
| ABBV-951 All Participants | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 6 | 2.38 nmol/L | Standard Deviation 111.069 |
| ABBV-951 All Participants | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 52 | 18.95 nmol/L | Standard Deviation 125.703 |
| ABBV-951 All Participants | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Week 26 | 3.86 nmol/L | Standard Deviation 95.865 |
Primary
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Population: Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 6 | 0.02 cells*10^9/L | Standard Deviation 1.705 |
| ABBV-951 Low Dose Subgroup | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 26 | 0.12 cells*10^9/L | Standard Deviation 1.892 |
| ABBV-951 Low Dose Subgroup | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 39 | 0.35 cells*10^9/L | Standard Deviation 4.014 |
| ABBV-951 Low Dose Subgroup | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 52 | -0.08 cells*10^9/L | Standard Deviation 2.027 |
| ABBV-951 High Dose Subgroup | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 52 | -0.04 cells*10^9/L | Standard Deviation 1.568 |
| ABBV-951 High Dose Subgroup | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 6 | 0.32 cells*10^9/L | Standard Deviation 2.12 |
| ABBV-951 High Dose Subgroup | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 39 | 0.38 cells*10^9/L | Standard Deviation 1.67 |
| ABBV-951 High Dose Subgroup | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 26 | 0.22 cells*10^9/L | Standard Deviation 2.99 |
| ABBV-951 All Participants | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 52 | -0.06 cells*10^9/L | Standard Deviation 1.829 |
| ABBV-951 All Participants | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 26 | 0.17 cells*10^9/L | Standard Deviation 2.46 |
| ABBV-951 All Participants | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 39 | 0.36 cells*10^9/L | Standard Deviation 3.202 |
| ABBV-951 All Participants | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Week 6 | 0.17 cells*10^9/L | Standard Deviation 1.919 |
Secondary
Average Daily Normalized Off Time: Change From Baseline to End of Study
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. Off time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily On and Off times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When Off was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized Off time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Time frame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 1 | -2.04 hours | Standard Deviation 3.51 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 6 | -2.43 hours | Standard Deviation 3.66 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 13 | -2.50 hours | Standard Deviation 3.83 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 26 | -3.31 hours | Standard Deviation 3.36 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 39 | -3.25 hours | Standard Deviation 3.43 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 52 | -3.43 hours | Standard Deviation 3.16 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 52 | -3.59 hours | Standard Deviation 3.11 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 1 | -1.84 hours | Standard Deviation 3.88 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 26 | -3.38 hours | Standard Deviation 3.15 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 39 | -3.52 hours | Standard Deviation 2.92 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 6 | -2.36 hours | Standard Deviation 3.56 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 13 | -2.34 hours | Standard Deviation 3.57 |
| ABBV-951 All Participants | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 6 | -2.40 hours | Standard Deviation 3.61 |
| ABBV-951 All Participants | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 13 | -2.43 hours | Standard Deviation 3.7 |
| ABBV-951 All Participants | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 52 | -3.51 hours | Standard Deviation 3.12 |
| ABBV-951 All Participants | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 26 | -3.35 hours | Standard Deviation 3.25 |
| ABBV-951 All Participants | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 1 | -1.95 hours | Standard Deviation 3.68 |
| ABBV-951 All Participants | Average Daily Normalized Off Time: Change From Baseline to End of Study | Week 39 | -3.37 hours | Standard Deviation 3.21 |
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Secondary
Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. On time is defined as periods of good motor symptom control. The daily On and Off times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized On time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement.
Time frame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 1 | 2.04 hours | Standard Deviation 3.55 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 6 | 2.99 hours | Standard Deviation 3.6 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 13 | 3.10 hours | Standard Deviation 3.32 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 26 | 3.92 hours | Standard Deviation 3.76 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 39 | 3.74 hours | Standard Deviation 3.4 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 52 | 4.08 hours | Standard Deviation 3.28 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 52 | 3.43 hours | Standard Deviation 3.28 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 1 | 1.74 hours | Standard Deviation 4.04 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 26 | 3.65 hours | Standard Deviation 3.31 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 39 | 3.69 hours | Standard Deviation 3.32 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 6 | 2.60 hours | Standard Deviation 3.58 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 13 | 2.72 hours | Standard Deviation 3.68 |
| ABBV-951 All Participants | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 6 | 2.81 hours | Standard Deviation 3.59 |
| ABBV-951 All Participants | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 13 | 2.93 hours | Standard Deviation 3.48 |
| ABBV-951 All Participants | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 52 | 3.77 hours | Standard Deviation 3.28 |
| ABBV-951 All Participants | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 26 | 3.79 hours | Standard Deviation 3.55 |
| ABBV-951 All Participants | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 1 | 1.90 hours | Standard Deviation 3.78 |
| ABBV-951 All Participants | Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Week 39 | 3.71 hours | Standard Deviation 3.35 |
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Secondary
Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. On time is defined as periods of good motor symptom control. The daily On and Off times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized On time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Time frame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 1 | -0.00 hours | Standard Deviation 2.1 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 6 | -0.56 hours | Standard Deviation 1.95 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 13 | -0.60 hours | Standard Deviation 1.72 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 26 | -0.61 hours | Standard Deviation 1.95 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 39 | -0.49 hours | Standard Deviation 1.07 |
| ABBV-951 Low Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 52 | -0.64 hours | Standard Deviation 1.73 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 52 | 0.17 hours | Standard Deviation 2.53 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 1 | 0.11 hours | Standard Deviation 1.64 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 26 | -0.27 hours | Standard Deviation 1.73 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 39 | -0.17 hours | Standard Deviation 1.59 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 6 | -0.23 hours | Standard Deviation 1.05 |
| ABBV-951 High Dose Subgroup | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 13 | -0.38 hours | Standard Deviation 1.04 |
| ABBV-951 All Participants | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 6 | -0.41 hours | Standard Deviation 1.6 |
| ABBV-951 All Participants | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 13 | -0.50 hours | Standard Deviation 1.45 |
| ABBV-951 All Participants | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 52 | -0.27 hours | Standard Deviation 2.16 |
| ABBV-951 All Participants | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 26 | -0.45 hours | Standard Deviation 1.85 |
| ABBV-951 All Participants | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 1 | 0.05 hours | Standard Deviation 1.89 |
| ABBV-951 All Participants | Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Week 39 | -0.35 hours | Standard Deviation 1.33 |
Comparison: Week 1 vs Baselinep-value: >0.999paired-sample t-test
Comparison: Week 1 vs Baselinep-value: =0.5095paired-sample t-test
Comparison: Week 1 vs Baselinep-value: =0.6962paired-sample t-test
Comparison: Week 6 vs Baselinep-value: =0.0035paired-sample t-test
Comparison: Week 6 vs Baselinep-value: =0.0324paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: =0.0072paired-sample t-test
Comparison: Week 13 vs Baselinep-value: =0.0129paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.0119paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.22paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.0063paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: =0.4331paired-sample t-test
Comparison: Week 39 vs Baselinep-value: =0.0045paired-sample t-test
Comparison: Week 52 vs Baselinep-value: =0.0049Wilcoxon (Mann-Whitney)
Comparison: Week 52 vs Baselinep-value: =0.6312paired-sample t-test
Comparison: Week 52 vs Baselinep-value: =0.1892paired-sample t-test
Secondary
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Time frame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Day 2 | -0.6 units on a scale | Standard Deviation 8.45 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 1 | 2.0 units on a scale | Standard Deviation 11.55 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 2 | 4.1 units on a scale | Standard Deviation 13.02 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 3 | 3.9 units on a scale | Standard Deviation 11.98 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 4 | 2.7 units on a scale | Standard Deviation 12.84 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 6 | 2.4 units on a scale | Standard Deviation 13.74 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 13 | 1.4 units on a scale | Standard Deviation 13.79 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 26 | 1.4 units on a scale | Standard Deviation 12.71 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 39 | 1.9 units on a scale | Standard Deviation 12.7 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 52 | 1.8 units on a scale | Standard Deviation 12.53 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 39 | 2.3 units on a scale | Standard Deviation 13.26 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Day 2 | -0.8 units on a scale | Standard Deviation 9.2 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 6 | -0.7 units on a scale | Standard Deviation 9.58 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 4 | 0.0 units on a scale | Standard Deviation 10.97 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 1 | 3.8 units on a scale | Standard Deviation 11 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 52 | 1.7 units on a scale | Standard Deviation 13.02 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 26 | 0.1 units on a scale | Standard Deviation 11.61 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 2 | 1.4 units on a scale | Standard Deviation 10.93 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 13 | -1.6 units on a scale | Standard Deviation 11.82 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 3 | 2.2 units on a scale | Standard Deviation 12.07 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 26 | 0.8 units on a scale | Standard Deviation 12.19 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 3 | 3.1 units on a scale | Standard Deviation 12.02 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 4 | 1.5 units on a scale | Standard Deviation 12.05 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 6 | 0.9 units on a scale | Standard Deviation 12.07 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 39 | 2.1 units on a scale | Standard Deviation 12.89 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 13 | 0.1 units on a scale | Standard Deviation 13.01 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Day 2 | -0.7 units on a scale | Standard Deviation 8.78 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 52 | 1.7 units on a scale | Standard Deviation 12.69 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 1 | 2.8 units on a scale | Standard Deviation 11.31 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | Week 2 | 2.9 units on a scale | Standard Deviation 12.18 |
Comparison: Day 2 vs Baselinep-value: =0.4447paired-sample t-test
Comparison: Day 2 vs Baselinep-value: =0.3567paired-sample t-test
Comparison: Day 2 vs Baselinep-value: =0.2315paired-sample t-test
Comparison: Week 1 vs Baselinep-value: =0.0667paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: =0.2033paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: =0.0012paired-sample t-test
Comparison: Week 3 vs Baselinep-value: =0.0734paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: =0.0304paired-sample t-test
Comparison: Week 4 vs Baselinep-value: >0.999paired-sample t-test
Comparison: Week 4 vs Baselinep-value: =0.0891paired-sample t-test
Comparison: Week 6 vs Baselinep-value: =0.0832paired-sample t-test
Comparison: Week 6 vs Baselinep-value: =0.4941paired-sample t-test
Comparison: Week 6 vs Baselinep-value: =0.2764paired-sample t-test
Comparison: Week 13 vs Baselinep-value: =0.3248paired-sample t-test
Comparison: Week 13 vs Baselinep-value: =0.2535paired-sample t-test
Comparison: Week 13 vs Baselinep-value: =0.9274paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.3297paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.9722paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.4403paired-sample t-test
Comparison: Week 39 vs Baselinep-value: =0.1946paired-sample t-test
Comparison: Week 39 vs Baselinep-value: =0.2077paired-sample t-test
Comparison: Week 39 vs Baselinep-value: =0.0692paired-sample t-test
Comparison: Week 52 vs Baselinep-value: =0.2276paired-sample t-test
Comparison: Week 52 vs Baselinep-value: 0.3369paired-sample t-test
Comparison: Week 52 vs Baselinep-value: =0.1218paired-sample t-test
Secondary
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Time frame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Day 2 | -2.8 units on a scale | Standard Deviation 4.55 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 1 | -3.6 units on a scale | Standard Deviation 4.98 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 2 | -3.3 units on a scale | Standard Deviation 6.06 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 3 | -3.5 units on a scale | Standard Deviation 5.83 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 4 | -2.6 units on a scale | Standard Deviation 5.5 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 6 | -2.5 units on a scale | Standard Deviation 6.6 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 13 | -3.2 units on a scale | Standard Deviation 6.44 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 26 | -2.6 units on a scale | Standard Deviation 6.27 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 39 | -2.6 units on a scale | Standard Deviation 6.32 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 52 | -2.1 units on a scale | Standard Deviation 6.94 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 39 | -4.0 units on a scale | Standard Deviation 6.93 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Day 2 | -1.2 units on a scale | Standard Deviation 4.25 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 6 | -4.2 units on a scale | Standard Deviation 6.09 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 4 | -4.9 units on a scale | Standard Deviation 6.32 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 1 | -3.9 units on a scale | Standard Deviation 5.85 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 52 | -4.5 units on a scale | Standard Deviation 7.07 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 26 | -3.9 units on a scale | Standard Deviation 7.05 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 2 | -3.4 units on a scale | Standard Deviation 6.53 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 13 | -4.3 units on a scale | Standard Deviation 6.57 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 3 | -3.9 units on a scale | Standard Deviation 6.63 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 26 | -3.2 units on a scale | Standard Deviation 6.65 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 3 | -3.7 units on a scale | Standard Deviation 6.21 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 4 | -3.7 units on a scale | Standard Deviation 5.98 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 6 | -3.3 units on a scale | Standard Deviation 6.41 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 39 | -3.2 units on a scale | Standard Deviation 6.61 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 13 | -3.7 units on a scale | Standard Deviation 6.5 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Day 2 | -2.1 units on a scale | Standard Deviation 4.47 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 52 | -3.2 units on a scale | Standard Deviation 7.07 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 1 | -3.7 units on a scale | Standard Deviation 5.4 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | Week 2 | -3.3 units on a scale | Standard Deviation 6.26 |
Comparison: Day 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Day 2 vs Baselinep-value: =0.0041paired-sample t-test
Comparison: Day 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: =0.0091paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Secondary
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Time frame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Day 2 | -2.6 units on a scale | Standard Deviation 4.28 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 1 | -2.6 units on a scale | Standard Deviation 5.84 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 2 | -2.5 units on a scale | Standard Deviation 5.29 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 3 | -2.3 units on a scale | Standard Deviation 5.65 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 4 | -1.7 units on a scale | Standard Deviation 6.22 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 6 | -1.1 units on a scale | Standard Deviation 7 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 13 | -1.8 units on a scale | Standard Deviation 5.8 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 26 | -1.1 units on a scale | Standard Deviation 5.01 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 39 | -0.7 units on a scale | Standard Deviation 5.64 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 52 | -0.5 units on a scale | Standard Deviation 5.3 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 39 | 0.1 units on a scale | Standard Deviation 6 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Day 2 | -1.8 units on a scale | Standard Deviation 3.61 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 6 | -1.7 units on a scale | Standard Deviation 5.15 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 4 | -3.0 units on a scale | Standard Deviation 5.42 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 1 | -3.3 units on a scale | Standard Deviation 5.5 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 52 | -1.3 units on a scale | Standard Deviation 6.22 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 26 | -0.7 units on a scale | Standard Deviation 5.88 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 2 | -2.1 units on a scale | Standard Deviation 5.1 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 13 | -1.7 units on a scale | Standard Deviation 5.59 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 3 | -2.9 units on a scale | Standard Deviation 5.91 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 26 | -0.9 units on a scale | Standard Deviation 5.42 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 3 | -2.6 units on a scale | Standard Deviation 5.77 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 4 | -2.3 units on a scale | Standard Deviation 5.88 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 6 | -1.4 units on a scale | Standard Deviation 6.21 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 39 | -0.4 units on a scale | Standard Deviation 5.8 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 13 | -1.7 units on a scale | Standard Deviation 5.69 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Day 2 | -2.3 units on a scale | Standard Deviation 4 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 52 | -0.9 units on a scale | Standard Deviation 5.71 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 1 | -2.9 units on a scale | Standard Deviation 5.68 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | Week 2 | -2.3 units on a scale | Standard Deviation 5.2 |
Comparison: Day 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: =0.0034paired-sample t-test
Comparison: Day 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Day 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: =0.0042paired-sample t-test
Comparison: Week 4 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: =0.1135paired-sample t-test
Comparison: Week 6 vs Baselinep-value: =0.0029paired-sample t-test
Comparison: Week 6 vs Baselinep-value: =0.0026paired-sample t-test
Comparison: Week 13 vs Baselinep-value: =0.0103paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.0493paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.3003paired-sample t-test
Comparison: Week 26 vs Baselinep-value: =0.0354paired-sample t-test
Comparison: Week 39 vs Baselinep-value: =0.2553paired-sample t-test
Comparison: Week 39 vs Baselinep-value: =0.864paired-sample t-test
Comparison: Week 39 vs Baselinep-value: =0.4774paired-sample t-test
Comparison: Week 52 vs Baselinep-value: =0.3865paired-sample t-test
Comparison: Week 52 vs Baselinep-value: 0.1186paired-sample t-test
Comparison: Week 52 vs Baselinep-value: =0.083paired-sample t-test
Secondary
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Time frame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Day 2 | -1.8 units on a scale | Standard Deviation 3.57 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 1 | -1.7 units on a scale | Standard Deviation 3.86 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 2 | -2.5 units on a scale | Standard Deviation 3.58 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 3 | -2.1 units on a scale | Standard Deviation 4.06 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 4 | -3.0 units on a scale | Standard Deviation 3.69 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 6 | -2.6 units on a scale | Standard Deviation 3.34 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 13 | -3.7 units on a scale | Standard Deviation 3.47 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 26 | -3.5 units on a scale | Standard Deviation 3.43 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 39 | -3.5 units on a scale | Standard Deviation 4.06 |
| ABBV-951 Low Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 52 | -4.1 units on a scale | Standard Deviation 3.75 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 39 | -3.5 units on a scale | Standard Deviation 4.11 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Day 2 | -1.1 units on a scale | Standard Deviation 3.45 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 6 | -2.8 units on a scale | Standard Deviation 3.9 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 4 | -2.6 units on a scale | Standard Deviation 3.78 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 1 | -1.7 units on a scale | Standard Deviation 4.1 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 52 | -3.8 units on a scale | Standard Deviation 4.71 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 26 | -3.5 units on a scale | Standard Deviation 4.12 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 2 | -2.3 units on a scale | Standard Deviation 3.56 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 13 | -3.3 units on a scale | Standard Deviation 4.04 |
| ABBV-951 High Dose Subgroup | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 3 | -2.3 units on a scale | Standard Deviation 3.74 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 26 | -3.5 units on a scale | Standard Deviation 3.76 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 3 | -2.2 units on a scale | Standard Deviation 3.9 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 4 | -2.8 units on a scale | Standard Deviation 3.73 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 6 | -2.7 units on a scale | Standard Deviation 3.61 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 39 | -3.5 units on a scale | Standard Deviation 4.07 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 13 | -3.5 units on a scale | Standard Deviation 3.74 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Day 2 | -1.5 units on a scale | Standard Deviation 3.52 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 52 | -3.9 units on a scale | Standard Deviation 4.19 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 1 | -1.7 units on a scale | Standard Deviation 3.96 |
| ABBV-951 All Participants | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | Week 2 | -2.4 units on a scale | Standard Deviation 3.57 |
Comparison: Day 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Day 2 vs Baselinep-value: =0.002paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 1 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Day 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 2 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 3 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 4 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Secondary
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline.
Time frame: Baseline, Weeks 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 39 | -7.8 units on a scale | Standard Deviation 13.81 |
| ABBV-951 Low Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 26 | -7.4 units on a scale | Standard Deviation 13 |
| ABBV-951 Low Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 6 | -7.0 units on a scale | Standard Deviation 14.53 |
| ABBV-951 Low Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 13 | -8.3 units on a scale | Standard Deviation 15.33 |
| ABBV-951 Low Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 52 | -7.2 units on a scale | Standard Deviation 14.65 |
| ABBV-951 High Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 26 | -7.1 units on a scale | Standard Deviation 12.27 |
| ABBV-951 High Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 6 | -8.4 units on a scale | Standard Deviation 10.53 |
| ABBV-951 High Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 13 | -8.2 units on a scale | Standard Deviation 11.18 |
| ABBV-951 High Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 39 | -7.5 units on a scale | Standard Deviation 13.58 |
| ABBV-951 High Dose Subgroup | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 52 | -7.2 units on a scale | Standard Deviation 12.35 |
| ABBV-951 All Participants | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 52 | -7.2 units on a scale | Standard Deviation 13.65 |
| ABBV-951 All Participants | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 39 | -7.7 units on a scale | Standard Deviation 13.66 |
| ABBV-951 All Participants | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 6 | -7.6 units on a scale | Standard Deviation 12.81 |
| ABBV-951 All Participants | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 26 | -7.3 units on a scale | Standard Deviation 12.62 |
| ABBV-951 All Participants | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | Week 13 | -8.3 units on a scale | Standard Deviation 13.57 |
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Secondary
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 \[never\] to 4 \[very often\] with the exception of Question 1 score ranging from 0 \[very often\] to 4 \[never\]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline.
Time frame: Baseline, Weeks 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 39 | -7.0 units on a scale | Standard Deviation 11.19 |
| ABBV-951 Low Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 26 | -5.0 units on a scale | Standard Deviation 13.06 |
| ABBV-951 Low Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 6 | -5.0 units on a scale | Standard Deviation 11.39 |
| ABBV-951 Low Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 13 | -6.9 units on a scale | Standard Deviation 10.76 |
| ABBV-951 Low Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 52 | -6.5 units on a scale | Standard Deviation 12.34 |
| ABBV-951 High Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 26 | -8.4 units on a scale | Standard Deviation 8.07 |
| ABBV-951 High Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 6 | -7.3 units on a scale | Standard Deviation 8.81 |
| ABBV-951 High Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 13 | -8.2 units on a scale | Standard Deviation 8.89 |
| ABBV-951 High Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 39 | -7.2 units on a scale | Standard Deviation 9.21 |
| ABBV-951 High Dose Subgroup | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 52 | -8.7 units on a scale | Standard Deviation 8.19 |
| ABBV-951 All Participants | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 52 | -7.5 units on a scale | Standard Deviation 10.75 |
| ABBV-951 All Participants | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 39 | -7.1 units on a scale | Standard Deviation 10.32 |
| ABBV-951 All Participants | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 6 | -6.1 units on a scale | Standard Deviation 10.31 |
| ABBV-951 All Participants | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 26 | -6.6 units on a scale | Standard Deviation 11.12 |
| ABBV-951 All Participants | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | Week 13 | -7.5 units on a scale | Standard Deviation 9.94 |
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Secondary
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.
Time frame: Baseline, Weeks 6, 13, 26, 39, and 52
Population: Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-951 Low Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 6 | 0.060 units on a scale | Standard Deviation 0.1921 |
| ABBV-951 Low Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 39 | 0.075 units on a scale | Standard Deviation 0.1842 |
| ABBV-951 Low Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 26 | 0.074 units on a scale | Standard Deviation 0.1771 |
| ABBV-951 Low Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 52 | 0.076 units on a scale | Standard Deviation 0.2062 |
| ABBV-951 Low Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 13 | 0.064 units on a scale | Standard Deviation 0.2153 |
| ABBV-951 High Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 39 | 0.129 units on a scale | Standard Deviation 0.1995 |
| ABBV-951 High Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 6 | 0.113 units on a scale | Standard Deviation 0.178 |
| ABBV-951 High Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 13 | 0.122 units on a scale | Standard Deviation 0.1984 |
| ABBV-951 High Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 26 | 0.122 units on a scale | Standard Deviation 0.1803 |
| ABBV-951 High Dose Subgroup | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 52 | 0.126 units on a scale | Standard Deviation 0.2213 |
| ABBV-951 All Participants | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 13 | 0.090 units on a scale | Standard Deviation 0.2092 |
| ABBV-951 All Participants | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 39 | 0.097 units on a scale | Standard Deviation 0.1916 |
| ABBV-951 All Participants | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 6 | 0.085 units on a scale | Standard Deviation 0.187 |
| ABBV-951 All Participants | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 52 | 0.097 units on a scale | Standard Deviation 0.2134 |
| ABBV-951 All Participants | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | Week 26 | 0.096 units on a scale | Standard Deviation 0.1795 |
Comparison: Week 6 vs Baselinep-value: =0.0035paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 6 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: =0.0098paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 13 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 26 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 39 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: =0.003paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test
Comparison: Week 52 vs Baselinep-value: <0.001paired-sample t-test