A Phase 2 interventional study of Placebo and BIIB033 100mg/Kg in Acute Optic Neuritis, sponsored by Biogen. Completed at 23 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by Biogen · Phase 2, Interventional, and Other
The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.
88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 58 interventional studies indexed under Optic Neuritis.
Browse Optic Neuritis studies →Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This was a follow-up study, investigational product was administered in the previous study. Participants in the placebo arm have received at least 1 dose of placebo.
Drug: Placebo
This was a follow-up study, investigational product was administered in the previous study. Participants in the BIIB033 arm have received at least 1 dose of 100 mg/kg BIIB033.
Drug: BIIB033 100mg/Kg
Administered as specified in the treatment arm.
Also known as: Sterile normal saline (0.9% sodium chloride for IV administration)
Drug page: Opicinumab
Administered as specified in the treatment arm.
FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161)
A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.
Time frame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161)
The diagnosis of clinically definite multiple sclerosis (CDMS) was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system.
Time frame: RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Time to Diagnosis of CDMS
The diagnosis of CDMS was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system. Time to diagnosis of CDMS in Study NCT02657915 was the time from the diagnosis of acute optic neuritis (AON) to the date of confirmed MS. Measured in Days using the Median (50th percentile) for each arm.
Time frame: RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)
The EDSS score is based on neurological testing and an examination of functional systems (FS), which are areas of the central nervous system which control bodily functions. These functional systems are: pyramidal (ability to walk), Cerebellar (coordination), brain stem (speech and swallowing), sensory (touch and pain), bowel and bladder functions, visual, mental and Other (includes any other neurological findings due to MS). An overall score ranging from 0 (normal) to 10 (disability) was calculated. Higher scores indicate greater disability.
Time frame: Day 1 (NCT02657915)
Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT)
SDMT is a screening test for cognitive impairment. Participants were given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). Originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.
Time frame: Day 1 (NCT02657915)
Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment
MSFC has 3 component- timed 25-foot walk (T25FW), 9-hole peg test (9HPT) \[dominant and nondominant hands\] and (3-second) paced auditory serial addition Test (PASAT). The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT + ZPASAT-3)/3, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z \>0) or lower (Z \<0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes.
Time frame: Day 1 (NCT02657915)
Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Change in disease activity from baseline with brain magnetic resonance imaging (MRI) was calculated and reported. MRI analysis included number of consensus GD-enhanced lesions as a measure of disease activity.
Time frame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Change in disease activity from baseline with brain magnetic MRI was calculated and reported. MRI analysis included volume of T2 lesions as disease activity.
Time frame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
| Milestone | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Started | 24 | 28 |
| Intent-to treat (itt) population | 24 | 28 |
| Per-protocol population | 23 | 24 |
| Completed | 24 | 28 |
| Not completed | 0 | 0 |
A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.
| milliseconds (msec) | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Baseline | 100.68 ± 4.854 | 102.29 ± 5.507 |
| Day 1 | 119.52 ± 13.395 | 114.20 ± 14.235 |
The diagnosis of clinically definite multiple sclerosis (CDMS) was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system.
| participants | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161) | 12 | 12 |
The diagnosis of CDMS was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system. Time to diagnosis of CDMS in Study NCT02657915 was the time from the diagnosis of acute optic neuritis (AON) to the date of confirmed MS. Measured in Days using the Median (50th percentile) for each arm.
| days | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Time to Diagnosis of CDMS | 386.0 (212.0 to 1065.0) | 909.5 (281.0 to NA) |
The EDSS score is based on neurological testing and an examination of functional systems (FS), which are areas of the central nervous system which control bodily functions. These functional systems are: pyramidal (ability to walk), Cerebellar (coordination), brain stem (speech and swallowing), sensory (touch and pain), bowel and bladder functions, visual, mental and Other (includes any other neurological findings due to MS). An overall score ranging from 0 (normal) to 10 (disability) was calculated. Higher scores indicate greater disability.
| score on a scale | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS) | 1.22 ± 0.837 | 1.26 ± 1.136 |
SDMT is a screening test for cognitive impairment. Participants were given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). Originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.
| score on a scale | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT) | 56.7 ± 9.91 | 58.7 ± 9.01 |
MSFC has 3 component- timed 25-foot walk (T25FW), 9-hole peg test (9HPT) \[dominant and nondominant hands\] and (3-second) paced auditory serial addition Test (PASAT). The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT + ZPASAT-3)/3, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z \>0) or lower (Z \<0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes.
| Z-score | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment | -0.82 ± 2.883 | -0.06 ± 0.804 |
Change in disease activity from baseline with brain magnetic resonance imaging (MRI) was calculated and reported. MRI analysis included number of consensus GD-enhanced lesions as a measure of disease activity.
| lesions | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Baseline | 0.2 ± 0.69 | 0.1 ± 0.41 |
| Change at Day 1 | 0.2 ± 1.54 | -0.1 ± 0.46 |
Change in disease activity from baseline with brain magnetic MRI was calculated and reported. MRI analysis included volume of T2 lesions as disease activity.
| millilitres (mL) | Placebo | BIIB033 (Opicinumab) 100 mg/kg |
|---|---|---|
| Baseline | 0.9710 ± 0.93551 | 0.7341 ± 1.29222 |
| Change at Day 1 | 0.5090 ± 1.38861 | 0.6244 ± 0.74850 |
Collected over Day 1 (NCT02657915). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| BIIB033 (Opicinumab) 100 mg/kg | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
The intent-to-treat (ITT) population was defined as all randomized participants who received at least 1 dose of study treatment in RENEW Study (NCT01721161) and completed at least 1 of the Day 1 assessments in this study.
| Age, Continuous(years) | Placebo | BIIB033 (Opicinumab) 100 mg/kg | Total |
|---|---|---|---|
| Mean | 35.6 ± 7.96 | 34.6 ± 6.57 | 35.1 ± 7.19 |
| Sex: Female, Male(Participants) | Placebo | BIIB033 (Opicinumab) 100 mg/kg | Total |
|---|---|---|---|
| Female | 19 | 19 | 38 |
| Male | 5 | 9 | 14 |
| Race/Ethnicity, Customized(Participants) | Placebo | BIIB033 (Opicinumab) 100 mg/kg | Total |
|---|---|---|---|
| White | 4 | 4 | 8 |
| Not reported | 20 | 24 | 44 |
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Studies of the drug tested here: Opicinumab