Trial Outcomes & Findings for Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) (NCT NCT03222973)
NCT ID: NCT03222973
Last Updated: 2022-04-28
Results Overview
Overall Response Score is a multicomponent score based on 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the nondominant hand (9HPT-ND). Overall Score was sum of 4 components at each visit and ranges from +4 (improvement) to -4 (worsening). At each visit, each component is given a score relative to baseline (BL): -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. For T25FW and 9HPT improvement is ≥15% decrease in time from BL and worsening is ≥15% increase in time from BL. For EDSS, improvement is: ≥1.0-point decrease in EDSS from a BL score of ≤6.0, and worsening is defined as a ≥1-point increase from a BL score of ≤5.5 or a ≥0.5-point increase from a BL score equal to 6.0. Positive Overall Response Score indicated that there was improvement in more components than there was worsening.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
263 participants
Primary outcome timeframe
Part 1: Baseline to Week 72
Results posted on
2022-04-28
Participant Flow
Participants were enrolled at the investigative sites in the Australia, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom and United States from 15 November 2017 to 12 February 2021.
A total of 263 participants with relapsing multiple sclerosis (RMS) were randomized in Part 1 (Placebo-controlled) of the study to receive BIIB033 or placebo. Participants who completed Part 1 and were eligible were enrolled into Part 2 (Open-label) of the study to receive BIIB033. Part 2 of the study was terminated early based on Sponsor's decision.
Participant milestones
| Measure |
Part 1: Placebo
Participants with RMS received placebo intravenously (IV) as an add-on therapy to a background disease-modifying therapy (DMT) once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
Participants with RMS received BIIB033 750 milligrams (mg) IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 2: Placebo to BIIB033 750 mg
Participants who received placebo and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 80 weeks.
|
Part 2: BIIB033 750 mg
Participants who received BIIB033 and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 77 weeks.
|
|---|---|---|---|---|
|
Part 1 (Week 0 to Week 72)
STARTED
|
131
|
132
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
Intent-to-treat (ITT) Population
|
131
|
132
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
Safety Population
|
131
|
132
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
COMPLETED
|
107
|
118
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
NOT COMPLETED
|
24
|
14
|
0
|
0
|
|
Part 2 (Week 73 to Week 168)
STARTED
|
0
|
0
|
101
|
113
|
|
Part 2 (Week 73 to Week 168)
ITT Population
|
0
|
0
|
100
|
113
|
|
Part 2 (Week 73 to Week 168)
Safety Population
|
0
|
0
|
100
|
113
|
|
Part 2 (Week 73 to Week 168)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2 (Week 73 to Week 168)
NOT COMPLETED
|
0
|
0
|
101
|
113
|
Reasons for withdrawal
| Measure |
Part 1: Placebo
Participants with RMS received placebo intravenously (IV) as an add-on therapy to a background disease-modifying therapy (DMT) once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
Participants with RMS received BIIB033 750 milligrams (mg) IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 2: Placebo to BIIB033 750 mg
Participants who received placebo and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 80 weeks.
|
Part 2: BIIB033 750 mg
Participants who received BIIB033 and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 77 weeks.
|
|---|---|---|---|---|
|
Part 1 (Week 0 to Week 72)
Adverse Event
|
3
|
0
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
Consent Withdrawn
|
12
|
9
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
Death
|
0
|
1
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
Pregnancy
|
0
|
1
|
0
|
0
|
|
Part 1 (Week 0 to Week 72)
Other
|
8
|
2
|
0
|
0
|
|
Part 2 (Week 73 to Week 168)
Adverse Event
|
0
|
0
|
2
|
0
|
|
Part 2 (Week 73 to Week 168)
Consent Withdrawn
|
0
|
0
|
10
|
11
|
|
Part 2 (Week 73 to Week 168)
Investigator Decision
|
0
|
0
|
2
|
1
|
|
Part 2 (Week 73 to Week 168)
Pregnancy
|
0
|
0
|
2
|
1
|
|
Part 2 (Week 73 to Week 168)
Other
|
0
|
0
|
84
|
100
|
|
Part 2 (Week 73 to Week 168)
Participants Not Dosed
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Part 1: Placebo
n=131 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 9.25 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 9.12 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Part 1: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to their treatment assignment regardless of actual treatment received.
Overall Response Score is a multicomponent score based on 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the nondominant hand (9HPT-ND). Overall Score was sum of 4 components at each visit and ranges from +4 (improvement) to -4 (worsening). At each visit, each component is given a score relative to baseline (BL): -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. For T25FW and 9HPT improvement is ≥15% decrease in time from BL and worsening is ≥15% increase in time from BL. For EDSS, improvement is: ≥1.0-point decrease in EDSS from a BL score of ≤6.0, and worsening is defined as a ≥1-point increase from a BL score of ≤5.5 or a ≥0.5-point increase from a BL score equal to 6.0. Positive Overall Response Score indicated that there was improvement in more components than there was worsening.
Outcome measures
| Measure |
Part 1: Placebo
n=131 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 1: Overall Response Score
|
-0.04 score on a scale
Interval -0.18 to 0.11
|
0.11 score on a scale
Interval -0.03 to 0.25
|
PRIMARY outcome
Timeframe: Part 2: Baseline to Week 169Population: Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.
Outcome measures
| Measure |
Part 1: Placebo
n=100 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=113 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 2: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
71 Participants
|
76 Participants
|
|
Part 2: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Part 1: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to their treatment assignment regardless of actual treatment received.
EDSS measures disability status over time in MS on a scale ranging from 0 to 10, with higher scores indicating more disability. For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a BL score of ≤6.0. T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet that is averaged between two completed trials. Longer time indicates slower walking. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. Longer time indicates poorer upper limb function. For T25FW and 9HPT ≥15% decrease in time from BL indicates improvement.
Outcome measures
| Measure |
Part 1: Placebo
n=131 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND
|
37 percentage of participants
|
39 percentage of participants
|
SECONDARY outcome
Timeframe: Part 1: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to their treatment assignment regardless of actual treatment received.
EDSS measures disability status over time in MS (scale range: 0-10), higher scores=more disability and improvement defined as ≥1.0-point decrease in EDSS from BL score ≤6.0. T25FW is quantitative mobility and leg function performance test, where timed walk over 25 feet that is averaged between two completed trials. Longer time=slower walking. 9HPT is quantitative test of upper extremity function, measures time to place 9 pegs into 9 holes and then remove pegs. Longer time=poorer upper limb function. PASAT assesses auditory information processing speed. In 3-second PASAT, numbers are presented at a rate of 1 every 3 seconds with scores (range 0-120), higher scores=better working memory. For T25FW and 9HPT ≥15% decrease in time from BL is improvement. For PASAT ≥15% increase from BL is improvement.
Outcome measures
| Measure |
Part 1: Placebo
n=131 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or 3-Second Paced Auditory Serial Addition Test (PASAT-3)
|
60 percentage of participants
|
52 percentage of participants
|
SECONDARY outcome
Timeframe: Part 1: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to their treatment assignment regardless of actual treatment received.
EDSS measures disability status over time in MS on a scale ranging from 0 to 10, with higher scores indicating more disability. For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a BL score of ≤6.0, and worsening is defined as a ≥1-point increase from a BL score of ≤5.5 or a ≥0.5-point increase from a BL score equal to 6.0. T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet that is averaged between two completed trials. Longer time indicates slower walking. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. Longer time indicates poorer upper limb function. For T25FW and 9HPT ≥15% decrease in time from BL indicates improvement and ≥15% increase in time from BL indicates worsening.
Outcome measures
| Measure |
Part 1: Placebo
n=131 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and Without Confirmed Worsening in Any of the 4 Assessments During the 72 Weeks of the Study
|
31 percentage of participants
|
28 percentage of participants
|
SECONDARY outcome
Timeframe: Part 1: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to their treatment assignment regardless of actual treatment received.
EDSS measures disability status over time in MS on a scale (range 0-10), higher scores=more disability. For EDSS, improvement is: a ≥1.0-point decrease in EDSS from a BL score of ≤6.0. T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet that is averaged between two completed trials. Longer time=slower walking. 9HPT is quantitative test of upper extremity function that measures time it takes to place 9 pegs into 9 holes and then remove pegs. Longer time=poorer upper limb function. For T25FW and 9HPT ≥15% decrease in time from BL indicates improvement. The SDMT measures time to pair abstract geometric symbols with specific numbers. The score is the number of correctly coded items (range 0-110) in 90 seconds, higher scores=better outcome. Improvement is: ≥4-point increase from BL.
Outcome measures
| Measure |
Part 1: Placebo
n=131 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and Symbol Digit Modalities Test (SDMT)
|
63 percentage of participants
|
75 percentage of participants
|
SECONDARY outcome
Timeframe: Part 1: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to their treatment assignment regardless of actual treatment received.
EDSS measures disability status over time in MS on a scale ranging from 0 to 10, with higher scores indicating more disability. For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a BL score of ≤6.0. T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet that is averaged between two completed trials. Longer time indicates slower walking. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. Longer time indicates poorer upper limb function. For T25FW and 9HPT ≥15% decrease in time from BL indicates improvement.
Outcome measures
| Measure |
Part 1: Placebo
n=131 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% Thresholds for T25FW and 9HPT)
|
25 percentage of participants
|
32 percentage of participants
|
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 96Population: Part 1 of Study 215MS202 failed to meet its primary endpoint of ORS over 72 weeks. Trial also failed to show efficacy in its secondary endpoints. Thus, Sponsor decided to terminate Part 2 of study early, and no participants had the opportunity to complete Part 2 of the study. No data was collected as per the protocol prespecified Part 2 efficacy analyses to assess the long-term efficacy of BIIB033 in Part 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 108Population: Part 1 of Study 215MS202 failed to meet its primary endpoint of ORS over 72 weeks. Trial also failed to show efficacy in its secondary endpoints. Thus, Sponsor decided to terminate Part 2 of study early, and no participants had the opportunity to complete Part 2 of the study. No data was collected as per the protocol prespecified Part 2 efficacy analyses to assess the long-term efficacy of BIIB033 in Part 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 108Population: Part 1 of Study 215MS202 failed to meet its primary endpoint of ORS over 72 weeks. Trial also failed to show efficacy in its secondary endpoints. Thus, Sponsor decided to terminate Part 2 of study early, and no participants had the opportunity to complete Part 2 of the study. No data was collected as per the protocol prespecified Part 2 efficacy analyses to assess the long-term efficacy of BIIB033 in Part 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 96Population: Part 1 of Study 215MS202 failed to meet its primary endpoint of ORS over 72 weeks. Trial also failed to show efficacy in its secondary endpoints. Thus, Sponsor decided to terminate Part 2 of study early, and no participants had the opportunity to complete Part 2 of the study. No data was collected as per the protocol prespecified Part 2 efficacy analyses to assess the long-term efficacy of BIIB033 in Part 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 108Population: Part 1 of Study 215MS202 failed to meet its primary endpoint of ORS over 72 weeks. Trial also failed to show efficacy in its secondary endpoints. Thus, Sponsor decided to terminate Part 2 of study early, and no participants had the opportunity to complete Part 2 of the study. No data was collected as per the protocol prespecified Part 2 efficacy analyses to assess the long-term efficacy of BIIB033 in Part 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 108Population: Part 1 of Study 215MS202 failed to meet its primary endpoint of ORS over 72 weeks. Trial also failed to show efficacy in its secondary endpoints. Thus, Sponsor decided to terminate Part 2 of study early, and no participants had the opportunity to complete Part 2 of the study. No data was collected as per the protocol prespecified Part 2 efficacy analyses to assess the long-term efficacy of BIIB033 in Part 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 96Population: Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation. 'Number Analyzed' signifies number of participants analyzed for this outcome measure.
Laboratory assessments including hematology and blood chemistry were evaluated for safety. Criteria for abnormality: In 10\^9/liter (L) \[white blood cells \<3.0/\>16, neutrophils \<1.5/ \>13.5, lymphocytes \<0.8/ \>12, monocytes \>2.5, eosinophils \>1.6, basophils \>1.6, platelets \<=75/ \>=700\], hemoglobin \<=95 \[female (F)\] or \<=115 \[male (M)\] or \>=175 (F) or \>=190 (M) gram per liter (g/L), hematocrit \<=32 (F) or \<=37 (M) or \>=54 (F) or \>=60 (M) percentage (%), red blood cells \<=3.5/ \>=6.4 10\^12/L, in millimoles per liter (mmol/L) \[sodium \<=126/ \>=156, potassium \<=3/ \>=6, chloride \<=90/ \>=118, bicarbonate \<=16/ \>=35, calcium \<=2/ \>=3, phosphorous \<=0.5491/ \>=1.7119, glucose (non-fasting) \<=2.2/\>=13.75\], AST/SGOT \>=3x upper limit of normal (ULN), ALT/SGPT \>=3xULN, alkaline phosphatase \>=3xULN, creatinine \>=1.5xULN, total bilirubin \>=1.5xULN, total protein \<=45/ \>=100 g/L, albumin \<=25 g/L, uric acid \>=501.5 (F)/\>=619.5 (M) micromole (umol)/L
Outcome measures
| Measure |
Part 1: Placebo
n=100 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=113 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
White blood cells [10^9/L]: <3.0
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
White blood cells (10^9/L): >16
|
2 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Neutrophils (10^9/L): <1.5
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Neutrophils (10^9/L): >13.5
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Lymphocytes (10^9/L): <0.8
|
13 Participants
|
15 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Lymphocytes (10^9/L): >12
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Monocytes (10^9/L): >2.5
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Eosinophils (10^9/L): >1.6
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Basophils (10^9/L): >1.6
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Hemoglobin (g/L): <=95 (F) or <=115 (M)
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Hemoglobin (g/L): >=175 (F) or >=190 (M)
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Hematocrit (%): <=32 (F) or <=37 (M)
|
2 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Hematocrit (%): >=54 (F) or >=60 (M)
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Red blood cells (10^12/L): <=3.5
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Red blood cells (10^12/L): >=6.4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Platelets (10^9/L): <=75
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Platelets (10^9/L): >=700
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Sodium (mmol/L): <=126
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Sodium (mmol/L): >=156
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Potassium (mmol/L): <=3
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Potassium (mmol/L): >=6
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Chloride (mmol/L): <=90
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Bicarbonate (mmol/L): <=16
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Bicarbonate (mmol/L): >=35
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Calcium (mmol/L): >=3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Phosphorus (mmol/L): <=0.5491
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Phosphorus (mmol/L): >=1.7119
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT): >=3xULN
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT): >=3xULN
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Alkaline phosphatase: >=3xULN
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Creatinine: >=1.5xULN
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Total bilirubin: >=1.5xULN
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Total protein (g/L): <=45
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Total protein (g/L): >=100
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Albumin (g/L): <=25
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Uric acid (umol)/L: >=501.5 (F) or >=619.5 (M)
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Glucose (non-fasting) (mmol/L): <=2.2
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Glucose (non-fasting) (mmol/L): >=13.75
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Chloride (mmol/L): >=118
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
Calcium (mmol/L): <=2
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 96Population: Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation. 'Number Analyzed' signifies number of participants analyzed at the specified timepoint for this outcome measure.
The ECG result was classified as "normal", "abnormal", "abnormal, not adverse event", or "abnormal, adverse event". Shift to 'abnormal, not adverse event' included shift from normal or unknown to 'abnormal, not adverse event'. Shift to 'abnormal, adverse event' included shift from normal or unknown to 'abnormal, adverse event'.
Outcome measures
| Measure |
Part 1: Placebo
n=100 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=113 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 24: Shift to Abnormal, not Adverse Event
|
4 Participants
|
8 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 24: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 36: Shift to Abnormal, not Adverse Event
|
3 Participants
|
10 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 36: Shift to Abnormal, Adverse Event
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 48: Shift to Abnormal, not Adverse Event
|
2 Participants
|
7 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 48: Shift to Abnormal, Adverse Event
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 60: Shift to Abnormal, not Adverse Event
|
3 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 84: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 96: Shift to Abnormal, not Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 60: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 72: Shift to Abnormal, not Adverse Event
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 72: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 84: Shift to Abnormal, not Adverse Event
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Day 1: Normal
|
83 Participants
|
89 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Day 1: Abnormal, not Adverse Event
|
10 Participants
|
16 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 12: Shift to Abnormal, not Adverse Event
|
7 Participants
|
6 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 12: Shift to Abnormal, Adverse Event
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Day 1 to Week 96: Shift to Abnormal, Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 12: Normal
|
80 Participants
|
81 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 12: Abnormal, not Adverse Event
|
9 Participants
|
16 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 12: Abnormal, Adverse Event
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 24: Shift to Abnormal, not Adverse Event
|
4 Participants
|
7 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 24: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 36: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 48: Shift to Abnormal, not Adverse Event
|
3 Participants
|
6 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 48: Shift to Abnormal, Adverse Event
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 60: Shift to Abnormal, not Adverse Event
|
5 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 60: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 72: Shift to Abnormal, not Adverse Event
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 72: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 84: Shift to Abnormal, not Adverse Event
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 84: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 96: Shift to Abnormal, not Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 96: Shift to Abnormal, Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 24: Normal
|
83 Participants
|
83 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 24: Abnormal, not Adverse Event
|
6 Participants
|
20 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 36: Shift to Abnormal, not Adverse Event
|
5 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 36: Shift to Abnormal, Adverse Event
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 48: Shift to Abnormal, not Adverse Event
|
1 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 48: Shift to Abnormal, Adverse Event
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 72: Shift to Abnormal, not Adverse Event
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 72: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 84: Shift to Abnormal, not Adverse Event
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 84: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 96: Shift to Abnormal, not Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 96: Shift to Abnormal, Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 36: Normal
|
77 Participants
|
80 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 36: Abnormal, not Adverse Event
|
7 Participants
|
20 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 36: Abnormal, Adverse Event
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 48: Shift to Abnormal, not Adverse Event
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 48: Shift to Abnormal, Adverse Event
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 60: Shift to Abnormal, not Adverse Event
|
6 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 60: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 72: Shift to Abnormal, not Adverse Event
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 72: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 84: Shift to Abnormal, not Adverse Event
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 84: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 96: Shift to Abnormal, not Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 36 to Week 96: Shift to Abnormal, Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 48: Normal
|
74 Participants
|
76 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 48: Abnormal, not Adverse Event
|
4 Participants
|
15 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 48: Abnormal, Adverse Event
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 48 to Week 60: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 48 to Week 72: Shift to Abnormal, not Adverse Event
|
2 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 48 to Week 72: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 48 to Week 84: Shift to Abnormal, not Adverse Event
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 48 to Week 84: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 48 to Week 96: Shift to Abnormal, not Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 48 to Week 96: Shift to Abnormal, Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 60: Normal
|
53 Participants
|
52 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 60: Abnormal, not Adverse Event
|
6 Participants
|
10 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 60 to Week 72: Shift to Abnormal, not Adverse Event
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 60 to Week 72: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 60 to Week 84: Shift to Abnormal, not Adverse Event
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 60 to Week 84: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 60 to Week 96: Shift to Abnormal, not Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 60 to Week 96: Shift to Abnormal, Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 72: Normal
|
26 Participants
|
24 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 72: Abnormal, not Adverse Event
|
2 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 72 to Week 84: Shift to Abnormal, not Adverse Event
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 72 to Week 84: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 72 to Week 96: Shift to Abnormal, not Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 72 to Week 96: Shift to Abnormal, Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 84: Normal
|
7 Participants
|
7 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 84: Abnormal, not Adverse Event
|
0 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 84 to Week 96: Shift to Abnormal, not Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 84 to Week 96: Shift to Abnormal, Adverse Event
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 96: Normal
|
3 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
At Week 96: Abnormal, not Adverse Event
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 12 to Week 36: Shift to Abnormal, not Adverse Event
|
4 Participants
|
8 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 60: Shift to Abnormal, not Adverse Event
|
4 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 24 to Week 60: Shift to Abnormal, Adverse Event
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
From Week 48 to Week 60: Shift to Abnormal, not Adverse Event
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 96Population: Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
Vital sign measurements including temperature, pulse rate (supine), systolic blood pressure (BP) and diastolic (supine) BP were evaluated for safety. Criteria for abnormalities: Temperature: \>38 degree celsius (◦C) or \>=1 ◦C increase from baseline (BL); Pulse: \[\>100 beats per minute (bpm) or increase from BL of \>30 bpm\] or (\<40 bpm or decrease from BL of \>20 bpm); Systolic BP: \[\>160 millimeters of mercury (mmHg)/increase from BL of \>40 mmHg\] or (\<90 mmHg/decrease from BL of \>30 mmHg); Diastolic BP: (\>100 mmHg/increase from BL of \>30 mmHg) or (\<45 mmHg/decrease from BL of \>20 mmHg).
Outcome measures
| Measure |
Part 1: Placebo
n=100 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=113 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Temperature: >38 ◦C or >=1 ◦C Increase From BL
|
4 percentage of participants
|
5 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Pulse: (>100 bpm or increase from BL of >30 bpm) or (<40 bpm or decrease from BL of >20 bpm)
|
22 percentage of participants
|
25 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Pulse: >100 bpm or >30 bpm increase from BL
|
11 percentage of participants
|
15 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Pulse: <40 bpm or >20 bpm decrease from BL
|
13 percentage of participants
|
11 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Systolic BP: (>160 mmHg/increase from BL of >40 mmHg) or (<90 mmHg/decrease from BL of >30 mmHg)
|
8 percentage of participants
|
10 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Systolic BP: <90 mmHg or >30 mmHg decrease from BL
|
4 percentage of participants
|
8 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Diastolic BP: (>100 mmHg/increase from BL of >30 mmHg) or (<45 mmHg/decrease from BL of >20 mmHg)
|
13 percentage of participants
|
9 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Diastolic BP: >100 mmHg or >30 mmHg increase from BL
|
3 percentage of participants
|
4 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Diastolic BP: <45 mmHg or >20 mmHg decrease from BL
|
11 percentage of participants
|
5 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Systolic BP: >160 mmHg or >40 mmHg increase from BL
|
4 percentage of participants
|
4 percentage of participants
|
SECONDARY outcome
Timeframe: Part 2: Baseline, Week 12, 24, 36, 48, 72 and 96Population: Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation. 'Number Analyzed' signifies number of participants analyzed at the specified timepoint for this outcome measure.
Criteria for abnormality was defined as a \>7% increase or decrease in weight at the specified time point.
Outcome measures
| Measure |
Part 1: Placebo
n=100 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=113 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Baseline with Increase >7%
|
27 percentage of participants
|
15 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Baseline with Decrease >7%
|
4 percentage of participants
|
15 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 12 with Increase >7%
|
4 percentage of participants
|
3 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 12 with Decrease >7%
|
1 percentage of participants
|
2 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 24 with Increase >7%
|
10 percentage of participants
|
10 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 24 with Decrease >7%
|
1 percentage of participants
|
5 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 36 with Increase >7%
|
18 percentage of participants
|
5 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 36 with Decrease >7%
|
1 percentage of participants
|
7 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 48 with Increase >7%
|
20 percentage of participants
|
8 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 48 with Decrease >7%
|
0 percentage of participants
|
10 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 72 with Increase >7%
|
19 percentage of participants
|
15 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 72 with Decrease >7%
|
3 percentage of participants
|
12 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 96 with Increase >7%
|
30 percentage of participants
|
13 percentage of participants
|
|
Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
At Week 96 with Decrease >7%
|
4 percentage of participants
|
16 percentage of participants
|
SECONDARY outcome
Timeframe: Part 2: Baseline to Week 96Population: Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation. 'Number Analyzed' signifies number of participants analyzed for this outcome measure.
C-SSRS systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors". The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide.
Outcome measures
| Measure |
Part 1: Placebo
n=100 Participants
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=113 Participants
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
|---|---|---|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Ideation: Wish to be Dead
|
2 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Ideation: Non-specific Active Suicidal Thoughts
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Ideation: Active Suicidal Ideation with any Methods (not Plan) Without Intent to act
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Ideation: Active Suicidal Ideation with Some Intent to act, Without Specific Plan
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Ideation: Active Suicidal Ideation with Specific Plan and Intent
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Behavior: Preparatory Acts or Behavior
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Behavior: Aborted Attempt
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Behavior: Interrupted Attempt
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Behavior: Actual Attempt
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Behavior: Suicidal Behavior
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Suicidal Behavior: Suicide
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
Self-injurious Behavior Without Suicidal Intent
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1: Placebo
Serious events: 6 serious events
Other events: 91 other events
Deaths: 0 deaths
Part 1: BIIB033 750 mg
Serious events: 9 serious events
Other events: 93 other events
Deaths: 1 deaths
Part 2: Placebo to BIIB033 750 mg
Serious events: 9 serious events
Other events: 34 other events
Deaths: 0 deaths
Part 2: BIIB033 750 mg
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Placebo
n=131 participants at risk
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 participants at risk
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 2: Placebo to BIIB033 750 mg
n=100 participants at risk
Participants who received placebo and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 80 weeks.
|
Part 2: BIIB033 750 mg
n=113 participants at risk
Participants who received BIIB033 and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 77 weeks.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Gastrointestinal disorders
Coeliac artery compression syndrome
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
General disorders
Chest pain
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Pelvic abscess
|
0.76%
1/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Pyelonephritis
|
0.76%
1/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.76%
1/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.76%
1/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.76%
1/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Nervous system disorders
Uhthoff's phenomenon
|
0.76%
1/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Psychiatric disorders
Alcohol use disorder
|
0.76%
1/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.76%
1/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Systemic infection
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia stage 1
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.88%
1/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Nervous system disorders
Meningocele acquired
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.0%
1/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.88%
1/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
Other adverse events
| Measure |
Part 1: Placebo
n=131 participants at risk
Participants with RMS received placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 1: BIIB033 750 mg
n=132 participants at risk
Participants with RMS received BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks.
|
Part 2: Placebo to BIIB033 750 mg
n=100 participants at risk
Participants who received placebo and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 80 weeks.
|
Part 2: BIIB033 750 mg
n=113 participants at risk
Participants who received BIIB033 and completed Part 1 were enrolled into Part 2 to receive BIIB033 750 mg IV as an add-on therapy to a background DMT once every 4 weeks for up to a maximum of 77 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
11/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
4.5%
6/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
3.0%
3/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
5.3%
6/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Gastrointestinal disorders
Nausea
|
7.6%
10/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
8.3%
11/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
7/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
3.0%
4/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
General disorders
Fatigue
|
10.7%
14/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
10.6%
14/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Bronchitis
|
4.6%
6/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
7.6%
10/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Nasopharyngitis
|
22.9%
30/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
19.7%
26/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
4.0%
4/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
6.2%
7/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Sinusitis
|
3.8%
5/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
6.8%
9/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.3%
20/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
23.5%
31/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
5.0%
5/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
8.0%
9/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Infections and infestations
Urinary tract infection
|
14.5%
19/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
13.6%
18/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
6.0%
6/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
8.8%
10/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Injury, poisoning and procedural complications
Fall
|
9.2%
12/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
12.9%
17/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
4.0%
4/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
7.1%
8/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Investigations
Weight increased
|
2.3%
3/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
6.1%
8/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
10/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
6.1%
8/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
8/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
6.1%
8/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
7/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
1.5%
2/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
5.0%
5/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
7/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
7.6%
10/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Nervous system disorders
Dizziness
|
6.9%
9/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
3.8%
5/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Nervous system disorders
Headache
|
17.6%
23/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
14.4%
19/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
11.0%
11/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
8.0%
9/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
15.3%
20/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
17.4%
23/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
12.0%
12/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
11.5%
13/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Nervous system disorders
Paraesthesia
|
6.1%
8/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
5.3%
7/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
8/131 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
6.8%
9/132 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/100 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
0.00%
0/113 • Part 1: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 84); Part 2: From first dose through 12 weeks after administration of the last dose of study treatment (Up to Week 169)
Safety population included all participants who received at least 1 dose of study treatment. Participants were analyzed based on the actual treatment allocation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER