Acute Optic Neuritis
Conditions
Keywords
Optic Neuritis
Brief summary
The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral acute optic neuritis (AON). The secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this study population.
Interventions
BIOLOGICALBIIB033 (anti-LINGO-1 mAb)
100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
DRUGPlacebo
via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Ability to provide written consent and any authorization required by law. * Confirmed diagnosis of AON * All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment. Key
Exclusion criteria
* Prior episode(s) of optic neuritis or loss of vision not due to AON. * Subjects with an established diagnosis of multiple sclerosis are excluded except if newly diagnosed based on the current episode of AON and positive brain magnetic resonance imaging results consistent with the 2010 revisions to the McDonald's criteria. * Previous history of a clinically significant disease. * Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study. * History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus. * History or evidence of drug or alcohol abuse within 2 years prior to Screening. * Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline. NOTE: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population | Baseline, Week 24 | Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye. |
| Change in FF-VEP Latency at Week 24: Per-protocol Population | Baseline, Week 24 | Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population | Baseline, Week 24 | Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness. |
| Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population | Baseline, Week 24 | Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness. |
| Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population | Baseline, Week 24 | Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60. |
| Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population | Baseline, Week 24 | Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\*100. Adjusted for the baseline RNFL thickness. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 32 weeks | An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above. |
| Summary of BIIB033 Concentration | Up to 32 weeks | One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit. |
| Change in LCLA at Week 24: Per-protocol Population | Baseline, Week 24 | Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60. |
| Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population | Baseline, Week 24 | Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\*100. Adjusted for the baseline RNFL thickness. |
Countries
Australia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) | 41 |
| BIIB033 BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) | 41 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | BIIB033 | Placebo |
|---|---|---|---|
| Affected eye Left eye | 38 participants | 16 participants | 22 participants |
| Affected eye Right eye | 44 participants | 25 participants | 19 participants |
| Age, Continuous | 32.1 years STANDARD_DEVIATION 8.01 | 31.8 years STANDARD_DEVIATION 7.17 | 32.4 years STANDARD_DEVIATION 8.85 |
| AON signs and symptoms at screening or baseline Color desaturation | 65 participants | 32 participants | 33 participants |
| AON signs and symptoms at screening or baseline Relative afferent pupillary defect | 63 participants | 30 participants | 33 participants |
| AON signs and symptoms at screening or baseline Swollen optic disc | 20 participants | 12 participants | 8 participants |
| AON signs and symptoms at screening or baseline Uhthoff's symptom | 26 participants | 18 participants | 8 participants |
| AON signs and symptoms at screening or baseline Visual field defect | 63 participants | 34 participants | 29 participants |
| Brain Gd+ lesions before first dose | 0.4 lesions STANDARD_DEVIATION 1.4 | 0.2 lesions STANDARD_DEVIATION 1 | 0.5 lesions STANDARD_DEVIATION 1.6 |
| Criteria for AON diagnosis Decreased color vision | 63 participants | 33 participants | 30 participants |
| Criteria for AON diagnosis Decreased visual acuity | 77 participants | 41 participants | 36 participants |
| Criteria for AON diagnosis Not specified | 9 participants | 4 participants | 5 participants |
| Criteria for AON diagnosis Ocular pain | 67 participants | 36 participants | 31 participants |
| Criteria for AON diagnosis Relative afferent pupillary defect | 65 participants | 31 participants | 34 participants |
| Criteria for AON diagnosis Visual field defect | 69 participants | 37 participants | 32 participants |
| Days from confirmed AON diagnosis to first dose | 19.0 days STANDARD_DEVIATION 4.8 | 18.7 days STANDARD_DEVIATION 4.7 | 19.2 days STANDARD_DEVIATION 4.9 |
| Days from first AON symptom to first dose | 24.1 days STANDARD_DEVIATION 3.7 | 23.6 days STANDARD_DEVIATION 4 | 24.6 days STANDARD_DEVIATION 3.4 |
| FF-VEP conduction block in the affected eye at baseline FF-VEP conduction block | 15 participants | 10 participants | 5 participants |
| FF-VEP conduction block in the affected eye at baseline No FF-VEP conduction block | 67 participants | 31 participants | 36 participants |
| FF-VEP latency in the fellow eye at baseline | 102.2 ms STANDARD_DEVIATION 5.8 | 102.7 ms STANDARD_DEVIATION 6.4 | 101.7 ms STANDARD_DEVIATION 5.25 |
| RGCL/IPL thickness in the affected eye at baseline | 64.8 microns STANDARD_DEVIATION 7.2 | 63.8 microns STANDARD_DEVIATION 7.4 | 66.0 microns STANDARD_DEVIATION 6.9 |
| Sex: Female, Male Female | 58 Participants | 27 Participants | 31 Participants |
| Sex: Female, Male Male | 24 Participants | 14 Participants | 10 Participants |
| Volume of brain T2 lesions before first dose | 1.09 mL STANDARD_DEVIATION 1.63 | 1.09 mL STANDARD_DEVIATION 1.9 | 1.09 mL STANDARD_DEVIATION 1.32 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 41 | 27 / 41 |
| serious Total, serious adverse events | 2 / 41 | 5 / 41 |
Outcome results
Primary
Change in FF-VEP Latency at Week 24: Per-protocol Population
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
Time frame: Baseline, Week 24
Population: Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS)-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in FF-VEP Latency at Week 24: Per-protocol Population | 22.24 msec | Standard Error 2.61 |
| BIIB033 | Change in FF-VEP Latency at Week 24: Per-protocol Population | 14.69 msec | Standard Error 2.72 |
p-value: 0.050495% CI: [-15.12, 0.01]ANCOVA
Primary
Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
Time frame: Baseline, Week 24
Population: ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo). Last observation carried forward (LOCF) imputation was used if Week 24 data were missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population | 20.83 msec | Standard Error 2.53 |
| BIIB033 | Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population | 17.34 msec | Standard Error 2.53 |
p-value: 0.333795% CI: [-10.61, 3.65]ANCOVA
Secondary
Change in LCLA at Week 24: Per-protocol Population
Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.
Time frame: Baseline, Week 24
Population: Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in LCLA at Week 24: Per-protocol Population | LCLA 1.25% chart | 7.2 letters on a chart | Standard Error 1.8 |
| Placebo | Change in LCLA at Week 24: Per-protocol Population | LCLA 2.5% chart | 11.6 letters on a chart | Standard Error 2 |
| BIIB033 | Change in LCLA at Week 24: Per-protocol Population | LCLA 1.25% chart | 6.0 letters on a chart | Standard Error 2 |
| BIIB033 | Change in LCLA at Week 24: Per-protocol Population | LCLA 2.5% chart | 10.8 letters on a chart | Standard Error 2.2 |
Comparison: LCLA 1.25% chartp-value: 0.664595% CI: [-6.6, 4.3]ANCOVA
Comparison: LCLA 2.5%p-value: 0.801595% CI: [-6.7, 5.2]ANCOVA
Secondary
Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population
Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.
Time frame: Baseline, Week 24
Population: ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with an LCLA assessment at Baseline. LOCF imputation was used if Week 24 data were missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population | LCLA 1.25% chart | 8.1 letters on a chart | Standard Deviation 1.8 |
| Placebo | Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population | LCLA 2.5% chart | 11.9 letters on a chart | Standard Deviation 2 |
| BIIB033 | Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population | LCLA 1.25% chart | 6.5 letters on a chart | Standard Deviation 1.9 |
| BIIB033 | Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population | LCLA 2.5% chart | 11.0 letters on a chart | Standard Deviation 2 |
Comparison: LCLA 1.25% chartp-value: 0.537195% CI: [-6.9, 3.6]ANCOVA
Comparison: LCLA 2.5% chartp-value: 0.774195% CI: [-6.5, 4.9]ANCOVA
Secondary
Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population
Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.
Time frame: Baseline, Week 24
Population: ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with a valid RGCL/IPL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population | -9.90 µm | Standard Deviation 1.2 |
| BIIB033 | Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population | -11.05 µm | Standard Deviation 1.18 |
p-value: 0.497595% CI: [-4.51, 2.21]ANCOVA
Secondary
Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population
Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.
Time frame: Baseline, Week 24
Population: Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population | -10.17 µm | Standard Deviation 1.29 |
| BIIB033 | Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population | -11.93 µm | Standard Deviation 1.35 |
p-value: 0.350595% CI: [-5.5, 1.98]ANCOVA
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.
Time frame: 32 weeks
Population: Safety population: all participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a moderate or severe event | 22 participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a related serious event | 0 participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants discontinuing treatment due to event | 1 participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants withdrawing from study due to event | 2 participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with an event | 34 participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a severe event | 2 participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a related event | 8 participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a serious event | 2 participants |
| BIIB033 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a serious event | 5 participants |
| BIIB033 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a moderate or severe event | 21 participants |
| BIIB033 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with an event | 34 participants |
| BIIB033 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a related serious event | 3 participants |
| BIIB033 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a related event | 14 participants |
| BIIB033 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants discontinuing treatment due to event | 3 participants |
| BIIB033 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with a severe event | 3 participants |
| BIIB033 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants withdrawing from study due to event | 3 participants |
Secondary
Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population
Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\*100. Adjusted for the baseline RNFL thickness.
Time frame: Baseline, Week 24
Population: Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population | -12.22 percentage change | Standard Error 2.26 |
| BIIB033 | Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population | -16.98 percentage change | Standard Error 2.33 |
p-value: 0.148895% CI: [-11.26, 1.74]ANCOVA
Secondary
Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population
Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\*100. Adjusted for the baseline RNFL thickness.
Time frame: Baseline, Week 24
Population: ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) and a valid RNFL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population | -11.77 percentage change | Standard Error 2.08 |
| BIIB033 | Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population | -15.66 percentage change | Standard Error 2.03 |
p-value: 0.186895% CI: [-9.7, 1.92]ANCOVA
Secondary
Summary of BIIB033 Concentration
One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.
Time frame: Up to 32 weeks
Population: PK analysis population: all participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data on record. n=number of participants with a sample at given timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Summary of BIIB033 Concentration | Week 32; n=33 | 82.70 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 24; n=37 | 624.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Baseline predose; n=41 | 0.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Baseline postdose; n=40 | 2030.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 4 predose; n=41 | 375.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 4 postdose; n=37 | 2350.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 8 predose; n=38 | 537.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 8 postdose; n=36 | 2585.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 12 predose; n=36 | 622.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 12 postdose; n=34 | 2695.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 16 predose; n=35 | 593.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 16 postdose; n=34 | 2500.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 20 predose; n=37 | 673.00 µg/mL |
| Placebo | Summary of BIIB033 Concentration | Week 20 postdose; n=35 | 2530.00 µg/mL |