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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03222973
Registration number
NCT03222973
Ethics application status
Date submitted
17/07/2017
Date registered
19/07/2017
Date last updated
28/04/2022
Titles & IDs
Public title
Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies
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Secondary ID [1]
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2017-001224-22
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Secondary ID [2]
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215MS202
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Universal Trial Number (UTN)
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Trial acronym
AFFINITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BIIB033 (opicinumab)
Treatment: Drugs - Placebo
Experimental: BIIB033 (opicinumab) 750 mg - Participants with relapsing multiple sclerosis (RMS) will receive BIIB033 750 milligram (mg) intravenously (IV) as an add-on therapy to a background disease-modifying therapy (DMT) once every 4 weeks over 72 weeks in Part 1 and once every 4 weeks over 96 weeks in Part 2.
Placebo Comparator: Placebo - Participants with RMS will receive placebo IV as an add-on therapy to a background DMT once every 4 weeks over 72 weeks in Part 1 and BIIB033 once every 4 weeks over 96 weeks in Part 2. The placebo looks like BIIB033 but does not contain the active ingredient that is thought to have an effect on MS disease. The placebo used in this study is sterile normal saline (water with a small amount of sodium chloride [salt]).
Treatment: Drugs: BIIB033 (opicinumab)
Administered as specified in the treatment arm
Treatment: Drugs: Placebo
Administered as specified in the treatment arm
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Overall Response Score
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Assessment method [1]
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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.
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Timepoint [1]
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Part 1: Baseline to Week 72
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Primary outcome [2]
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Part 2: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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Part 2: Baseline to Week 169
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Secondary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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Part 1: Baseline to Week 72
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Secondary outcome [2]
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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)
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Assessment method [2]
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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.
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Timepoint [2]
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Part 1: Baseline to Week 72
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Secondary outcome [3]
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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
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Assessment method [3]
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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.
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Timepoint [3]
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Part 1: Baseline to Week 72
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Secondary outcome [4]
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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)
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Assessment method [4]
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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.
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Timepoint [4]
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Part 1: Baseline to Week 72
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Secondary outcome [5]
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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)
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Assessment method [5]
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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.
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Timepoint [5]
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Part 1: Baseline to Week 72
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Secondary outcome [6]
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Part 2: Overall Response Score
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Assessment method [6]
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Timepoint [6]
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Part 2: Baseline to Week 96
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Secondary outcome [7]
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Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND
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Assessment method [7]
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Timepoint [7]
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Part 2: Baseline to Week 108
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Secondary outcome [8]
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Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or PASAT-3
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Assessment method [8]
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Timepoint [8]
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Part 2: Baseline to Week 108
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Secondary outcome [9]
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Part 2: Percentage of Participants With 24-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 96 Weeks of the Study
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Assessment method [9]
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Timepoint [9]
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Part 2: Baseline to Week 96
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Secondary outcome [10]
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Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and SDMT
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Assessment method [10]
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Timepoint [10]
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Part 2: Baseline to Week 108
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Secondary outcome [11]
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Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% Thresholds for T25FW and 9HPT)
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Assessment method [11]
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Timepoint [11]
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Part 2: Baseline to Week 108
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Secondary outcome [12]
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Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values
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Assessment method [12]
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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
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Timepoint [12]
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Part 2: Baseline to Week 96
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Secondary outcome [13]
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Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values
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Assessment method [13]
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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'.
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Timepoint [13]
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Part 2: Baseline to Week 96
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Secondary outcome [14]
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Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
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Assessment method [14]
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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).
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Timepoint [14]
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Part 2: Baseline to Week 96
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Secondary outcome [15]
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Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values
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Assessment method [15]
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Criteria for abnormality was defined as a >7% increase or decrease in weight at the specified time point.
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Timepoint [15]
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Part 2: Baseline, Week 12, 24, 36, 48, 72 and 96
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Secondary outcome [16]
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Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
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Assessment method [16]
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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.
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Timepoint [16]
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Part 2: Baseline to Week 96
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Eligibility
Key inclusion criteria
Key Part 1
- Baseline Expanded Disability Status Scale (EDSS) of 2.0 to 6.0, have a diagnosis of
relapsing-remitting multiple sclerosis (RRMS) per the 2010 McDonald's criteria or
onset of secondary progressive multiple sclerosis (SPMS) per the Lublin and Reingold
criteria, and should have experienced their first MS symptom(s) within the previous 20
years.
- Subjects must have experienced at least 1 of the following within 24 months prior to
Day 1/Baseline: a clinical relapse (but not within 24 weeks prior to Day 1/Baseline),
gadolinium-enhancing lesions on brain or spinal cord magnetic resonance imaging (MRI),
or new T2 lesion(s) on brain or spinal cord MRI.
- Subjects must be on a stable dose of a protocol-specified anti-inflammatory
disease-modifying therapy (DMT) (IFNß [Avonex, Plegridy, Betaferon/Betaseron, or
Rebif], dimethyl fumarate (DMF) [Tecfidera], or natalizumab [Tysabri]) for at least 24
weeks prior to enrollment.
- In addition, subjects must have met protocol-defined MRI characteristics using
magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI) sequences at
Screening/Baseline.
Key Part 2
-Subjects who complete study treatment (BIIB033 or placebo) at Part 1/Week 72 Visit.
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Minimum age
18
Years
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Maximum age
58
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Part 1
- Primary progressive MS
- An MS relapse that has occurred within 24 weeks prior to Day 1/Baseline or the subject
has not stabilized from a previous relapse at the time of Screening.
- Treatment with any chemotherapeutic agents (e.g., mitoxantrone, cyclophosphamide,
cladribine), cell-depleting monoclonal antibodies (mAbs) (e.g., rituximab,
ocrelizumab, alemtuzumab), total lymphoid irradiation, T-cell or T-cell receptor
vaccination, or teriflunomide within 1 year prior to Day 1/Baseline.
- Treatment with other anti-inflammatory DMTs (e.g., GA, fingolimod, daclizumab) or
plasmapheresis within 24 weeks prior to Day1/Baseline.
- Treatment with Botox for limb spasticity within 24 weeks before Day 1/Baseline.
- Contraindications to MRI, for example, presence of pacemakers or other implanted metal
devices (excluding dental braces), an allergy to gadolinium renal impairment, or
claustrophobia that cannot be medically managed.
- History of human immunodeficiency virus or other immunodeficient conditions.
- History of malignancy; however, subjects with a history of excised or treated basal
cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in
this study.
Key Part 2
- Subjects who did not complete study treatment in Part 1/Week 72 Visit
- Subjects who have a duration >12 weeks between their Part 1/Week 72 Visit and Part
2/Day 1.
- Contraindications to MRI, for example, presence of pacemakers or other implanted metal
devices (excluding dental braces), an allergy to Gd, renal impairment, or
claustrophobia that cannot be medically managed.
- History of human immunodeficiency virus or other immunodeficient conditions not
related to DMT treatment.
- History of malignancy unless enrollment is approved by the Sponsor; subjects with a
history of excised or treated basal cell carcinoma or fewer than 3 squamous cell
carcinomas are eligible to participate in this study.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/11/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/02/2021
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Sample size
Target
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Accrual to date
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Final
263
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Research Site - Box Hill
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Research Site - Clayton
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Research Site - Heidelberg
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Research Site - Melbourne
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Research Site - Parkville
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Research Site - New Lambton Heights
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Research Site - Westmead
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3168 - Clayton
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3084 - Heidelberg
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3004 - Melbourne
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3050 - Parkville
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NS 2305 - New Lambton Heights
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Recruitment postcode(s) [7]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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Alabama
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Florida
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Czechia
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State/province [41]
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Jihlava
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Country [42]
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Czechia
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Pardubice
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Czechia
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Praha 2
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France
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Bas Rhin
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France
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Gard
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France
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Gironde
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France
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Haute Garonne
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France
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Herault
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France
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State/province [49]
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Loire Atlantique
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Country [50]
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France
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Nord
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France
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Puy De Dome
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France
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Rhone
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France
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Somme
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France
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Paris
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Germany
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Baden Wuerttemberg
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Germany
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Bavaria
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Germany
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North Rhine-Westphalia
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Germany
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Rhineland-Palatinate
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Germany
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Saxony
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Germany
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Berlin
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Germany
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Muenster
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Country [62]
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Hungary
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Budapest
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Hungary
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State/province [63]
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Esztergom
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Hungary
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Kistarcsa
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Hungary
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Pecs
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Israel
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Ramat Gan
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Country [67]
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Italy
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Brescia
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Country [68]
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Italy
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Isernia
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Country [69]
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Italy
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Palermo
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Country [70]
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Italy
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Genova
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Country [71]
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Italy
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Messina
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Italy
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Milano
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Country [73]
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Italy
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Napoli
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Italy
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Pisa
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Country [75]
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Italy
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Roma
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Country [76]
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Italy
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Verona
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Country [77]
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Netherlands
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Geleen
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Country [78]
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Poland
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State/province [78]
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Bydgoszcz
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Country [79]
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Poland
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Gdansk
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Country [80]
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Poland
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Katowice
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Poland
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Krakow
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Country [82]
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Poland
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Lodz
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Poland
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Lublin
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Country [84]
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Poland
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Szczecin
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Poland
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Warszawa
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State/province [86]
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Zabrze
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Country [87]
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Spain
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Girona
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Spain
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Madrid
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Spain
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Vizcaya
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Spain
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Barcelona
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Country [91]
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Spain
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Cordoba
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Spain
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Sevilla
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Switzerland
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Aarau
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Switzerland
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Basel
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Switzerland
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Bern
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Country [96]
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Switzerland
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Lugano
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Switzerland
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Zurich
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United Kingdom
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Devon
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United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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Country [101]
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Merseyside
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United Kingdom
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Nottinghamshire
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United Kingdom
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Oxfordshire
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Strathclyde
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United Kingdom
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Tyne & Wear
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West Yorkshire
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Brighton
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United Kingdom
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Sheffield
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biogen
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Address
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Ethics approval
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Summary
Brief summary
The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus
placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this
study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in
participants with MS.
The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on
additional measures of disability improvement. The secondary objective of Part 2 is to
investigate long-term efficacy (disability improvement) and additional safety measures of
BIIB033 as an add-on therapy in participants with MS.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03222973
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Public notes
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Contacts
Principal investigator
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Medical Director
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Biogen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03222973
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