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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/NCT04895241
Registration number
NCT04895241
Ethics application status
Date submitted
17/05/2021
Date registered
20/05/2021
Date last updated
30/04/2024
Titles & IDs
Public title
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
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Secondary ID [1]
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2023-505695-30
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Secondary ID [2]
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230LE303
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Universal Trial Number (UTN)
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Trial acronym
TOPAZ-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lupus Erythematosus, Systemic
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Litifilimab
Treatment: Drugs - Placebo
Experimental: Litifilimab High Dose - Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC) every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
Experimental: Litifilimab Low Dose - Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2.
Placebo Comparator: Placebo - Participants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
Treatment: Drugs: Litifilimab
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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Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
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Assessment method [1]
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SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of =4 points in systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K).
No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point Physician's Global Assessment (PGA) - Visual Analog Scale (VAS).
No violation to protocol-specified medication rules.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants Who Achieved an SRI-4 Response at Week 24
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Assessment method [1]
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SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of =4 points in SLEDAI-2K.
No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA -VAS.
No violation to protocol-specified medication rules.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
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Assessment method [2]
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Joint-50 response is 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Percentage of Participants with OCS =10 milligrams per day (mg/day) at Baseline Who Have OCS Reduction to =7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52
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Assessment method [3]
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No worsening of the disease is defined as no new BILAG-2004 grade A or less than 2 new BILAG-2004 grade B since the last visit during the Week 40 to Week 52.
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Timepoint [3]
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Week 40 to Week 52
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Secondary outcome [4]
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Percentage of Participants with a CLASI-A score =10 at Baseline Who Achieved a 50% Improvement From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 16
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Assessment method [4]
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Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in CLASI-A.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Annualized Flare Rate Through Week 52
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Assessment method [5]
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Annualized flare rate will be calculated as the total number of flares divided by the flare exposure time in days, and the ratio multiplied by 365.25.
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Timepoint [5]
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Up to Week 52
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Secondary outcome [6]
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Change from Baseline in Physician's Global Assessment (PGA) Visual Analog Scale (VAS) Score by Visit
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Assessment method [6]
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The PGA is an Investigator-administered assessment used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participant's current disease activity from a score of 0 (none) to 3 (severe), with the assessment made relative to the most severe state of SLE.
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Timepoint [6]
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Up to Week 52
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Secondary outcome [7]
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Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
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Assessment method [7]
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The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade C or D, no BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 grade A or greater than 1 new BILAG-2004 grade B, no worsening in the SLEDAI-2K total score compared with Baseline, no worsening from Baseline in lupus disease activity defined by < 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules.
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Timepoint [7]
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Up to Week 52
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Secondary outcome [8]
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Time to Onset of SRI-4 Response Sustained Through Week 52
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Assessment method [8]
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SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of =4 points in SLEDAI-2K.
No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA -VAS.
No violation to protocol-specified medication rules.
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Timepoint [8]
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Up to Week 52
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Secondary outcome [9]
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Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
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Assessment method [9]
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SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of =4 points in SLEDAI-2K.
No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA -VAS.
No violation to protocol-specified medication rules. The SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively.
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Timepoint [9]
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Up to Week 52
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Secondary outcome [10]
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Percentage of Participants with Joint-50 Response by Visit
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Assessment method [10]
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Joint-50 response is 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
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Timepoint [10]
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Up to Week 52
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Secondary outcome [11]
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Percentage of Participants with Baseline CLASI-A Score =10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit
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Assessment method [11]
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Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-20, -50, -70 and -90 represent 20%, 50%, 70% or 90% improvement from baseline in CLASI-A score, respectively.
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Timepoint [11]
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Up to Week 52
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Secondary outcome [12]
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Percentage of Participants with Baseline CLASI-A Score =10 Who Achieved a CLASI-A Score of = 1 by Visit
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Assessment method [12]
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Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-A =1 represent the absolute score =1 in CLASI-A by visit.
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Timepoint [12]
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Up to Week 52
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Secondary outcome [13]
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Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit
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Assessment method [13]
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BILAG-2004 severe flare is defined as an A score for items recorded as worse or new. BILAG-2004 is evaluated by scoring each item of a list of signs and symptoms given as 4 = new; 3 = worse; 2 = same; 1 = improving; 0 = not present; and ND = not done.
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Timepoint [13]
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Up to Week 52
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Secondary outcome [14]
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Time to First Severe Flare as defined by the Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI)
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Assessment method [14]
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SFI severe flare is defined any of the following: change in SLEDAI instrument score to >12; or new or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000 per milliliter (/mL); or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose; or increase to >0.5 milligrams per kilogram per day (mg/kg/day) or hospitalization; or increase in prednisone dose to >0.5 mg/kg/day; or new requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity; or hospitalization for SLE activity; or increase in PGA score to >2.5.
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Timepoint [14]
0
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Up to Week 52
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Secondary outcome [15]
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Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
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Assessment method [15]
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LLDAS is a composite endpoint defined as:
SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) PGA = 1; and
Current prednisone (or equivalent) dose = 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
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Timepoint [15]
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Up to Week 52
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Secondary outcome [16]
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Percentage of Participants With Sustained LLDAS as Defined by the Number of Participants With = 3, = 5, and = 7 Consecutive Visits in LLDAS up to and Including Week 52
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Assessment method [16]
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LLDAS is a composite endpoint defined as:
SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
SELENA-SLEDAI PGA = 1; and
Current prednisone (or equivalent) dose = 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
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Timepoint [16]
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Up to Week 52
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Secondary outcome [17]
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Percentage of Participants who Achieved LLDAS at Week 52
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Assessment method [17]
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LLDAS is a composite endpoint defined as:
SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
SELENA-SLEDAI PGA = 1; and
Current prednisone (or equivalent) dose = 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
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Timepoint [17]
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Week 52
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Secondary outcome [18]
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Percentage of Participants With Baseline OCS =10 mg/day Who Achieved =7.5 mg/day at Week 52
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Assessment method [18]
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Timepoint [18]
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Week 52
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Secondary outcome [19]
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Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
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Assessment method [19]
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The LupusQoL is a participant-reported, lupus-specific, Health-Related Quality-of-Life Questionnaire (HRQoL) consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL.
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Timepoint [19]
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Up to Week 52
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Secondary outcome [20]
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Change From Baseline in Short Form Health Survey-36 (SF-36) Score
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Assessment method [20]
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The SF-36 determines participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement.
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Timepoint [20]
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Up to Week 52
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Secondary outcome [21]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
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Assessment method [21]
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The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in the 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.
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Timepoint [21]
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Up to Week 52
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Secondary outcome [22]
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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
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Assessment method [22]
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The PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0-4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe.
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Timepoint [22]
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Up to Week 52
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Secondary outcome [23]
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Change From Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score
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Assessment method [23]
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WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity
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Timepoint [23]
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Up to Week 52
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Secondary outcome [24]
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [24]
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier. An SAE is any untoward medical occurrence that at any dose results in death (a life-threatening event), in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect, or is a medically important event.
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Timepoint [24]
0
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Up to Week 52
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Secondary outcome [25]
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Number of Participants with Antibodies to Litifilimab
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Assessment method [25]
0
0
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Timepoint [25]
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Up to Week 52
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Eligibility
Key inclusion criteria
Key
- Participant must be diagnosed with systemic lupus erythematosus (SLE) at least 24
weeks prior to screening and must meet the 2019 European League Against Rheumatism
(EULAR) / American College of Rheumatology (ACR) classification criteria for SLE at
screening by a qualified physician.
- Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-2000
(SLEDAI-2K) score = 6 (excluding alopecia, fever, lupus-related headache, and organic
brain syndrome) at screening (adjudicated).
- Participant has a modified clinical SLEDAI-2K score = 4 (excluding anti-dsDNA, low
complement component 3 (C3) and/or complement component 4 (C4), alopecia, fever,
lupus-related headache, and organic brain syndrome) at Screening (adjudicated) and
randomization.
- Participant has BILAG-2004 grade A in = 1 organ system or BILAG-2004 grade B in = 2
organ systems at Screening (adjudicated) and randomization.
- Participant must be treated with one of the following background nonbiologic lupus SOC
therapies, initiated = 12 weeks prior to Screening and at stable dose = 4 weeks prior
to randomization:
1. Antimalarials as stand-alone treatment
2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant
3. Treatment with OCS and/or a single immunosuppressant
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Minimum age
18
Years
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Maximum age
No limit
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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
- History of or positive test result for human immunodeficiency virus (HIV).
- Current hepatitis C infection (defined as positive hepatitis C virus (HCV) antibody
and detectable HCV ribonucleic acid [RNA]).
- Current hepatitis B infection (defined as positive for antibody to hepatitis B surface
antigen (HBsAg) and/or positive for total hepatitis antibody to B core antigen
[anti-HBc] with positive reflex HBV DNA).
- History of severe herpes infection.
- Presence of uncontrolled or New York Heart Association class III or IV congestive
heart failure.
- Active severe lupus nephritis where, in the opinion of the Investigator,
protocol-specified SOC is insufficient and use of a more aggressive therapeutic
approach is indicated, such as adding IV cyclophosphamide and/or high-dose IV pulse
corticosteroid therapy or other treatments not permitted in the protocol is indicated;
or urine protein-creatinine ratio > 2.0 or severe chronic kidney disease (estimated
glomerular filtration rate < 30 milliliters per minute per 1.73 meter square
[mL/min/1.73 m^2]) calculated using the abbreviated modification of diet in renal
disease equation.
- Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may
interfere with the study assessment of CLE such as but not limited to psoriasis,
dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced
lupus.
- History or current diagnosis of a clinically significant non-SLE-related vasculitis
syndrome.
- Active neuropsychiatric SLE.
- Use of oral prednisone (or equivalent) above 20 mg/day.
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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
25/05/2021
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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
12/09/2025
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Actual
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Sample size
Target
540
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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0
Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Box Hill Hospital - Box Hill
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Recruitment hospital [3]
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Footscray Hospital - Footscray
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Recruitment hospital [4]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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0
2050 - Camperdown
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Recruitment postcode(s) [2]
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0
3128 - Box Hill
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Recruitment postcode(s) [3]
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3011 - Footscray
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
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0
Colorado
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0
0
United States of America
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State/province [3]
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0
District of Columbia
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Country [4]
0
0
United States of America
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State/province [4]
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0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
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0
Michigan
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Missouri
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Country [7]
0
0
United States of America
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State/province [7]
0
0
New York
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Country [8]
0
0
United States of America
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State/province [8]
0
0
North Carolina
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Ohio
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Tennessee
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Texas
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Washington
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Country [13]
0
0
Brazil
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State/province [13]
0
0
Bahia
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Country [14]
0
0
Brazil
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State/province [14]
0
0
Ceará
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Distrito Federal
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Country [16]
0
0
Brazil
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State/province [16]
0
0
Espírito Santo
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Country [17]
0
0
Brazil
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State/province [17]
0
0
Mato Grosso
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Country [18]
0
0
Brazil
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State/province [18]
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Minas Gerais
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Orenburg
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Sevilla
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Valencia
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Kaohsiung
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Funding & Sponsors
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Biogen
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Summary
Brief summary
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in
participants with systemic lupus erythematosus (SLE). The study will focus on participants
who have active disease and are already taking standard of care medications. These may
include antimalarials, steroids, and immunosuppressants.
The main objective of the study is to learn about the effect litifilimab has on lowering the
activity of the disease. The main question researchers want to answer is:
- How many participants have an improvement in their symptoms after 52 weeks of treatment?
Researchers will answer this and other questions by measuring the symptoms of SLE over time
using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic
Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global
Assessment - Visual Analog Scale (PGA-VAS).
Researchers will also learn more about the safety of litifilimab. They will study how
participants' immune systems respond to litifilimab. Additionally, they will measure the
effect litifilimab and SLE have on the quality of life of participants using a group of
questionnaires.
The study will be done as follows:
- After screening, participants will be randomized to receive either a high or low dose of
litifilimab, or placebo. A placebo looks like the study drug but contains no real
medicine.
- All participants will receive either litifilimab or placebo as injections under the skin
once every 4 weeks. The treatment period will last 52 weeks. Participants will continue
to take their standard of care medications.
- Neither the researchers nor the participants will know if the participants are receiving
litifilimab or placebo.
- There will be a follow-up safety period that lasts up to 24 weeks.
- In total, participants will have up to 22 study visits. The total study duration for
participants will be up to 80 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04895241
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Biogen
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US Biogen Clinical Trial Center
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866-633-4636
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[email protected]
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04895241
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