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A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care (TOPAZ-1)

Primary Purpose

Lupus Erythematosus, Systemic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BIIB059 (litifilimab)
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Lupus, SLE, CLE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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 immunosuppressants
    3. Treatment with OCS and/or immunosuppressants

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 hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody [anti-HBc]).
  • 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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BIIB059 High Dose

BIIB059 Low Dose

Placebo

Arm Description

Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059, subcutaneously (SC) every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.

Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of BIIB059, SC Q4W, up to Week 48 with an additional dose at Week 2.

Participants who are receiving background nonbiologic lupus SOC therapy will receive BIIB059 matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
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.

Secondary Outcome Measures

Percentage of Participants Who Achieved an SRI-4 Response at Week 24
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.
Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
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.
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
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.
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
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.
Annualized Flare Rate Through Week 52
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.
Change from Baseline in Physician's Global Assessment (PGA) Visual Analog Scale (VAS) Score by Visit
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.
Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
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.
Time to Onset of SRI-4 Response Sustained Through Week 52
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.
Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
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.
Percentage of Participants with Joint-50 Response by Visit
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.
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit
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.
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤ 1 by Visit
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.
Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit
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.
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)
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.
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
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.
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
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.
Percentage of Participants who Achieved LLDAS at Week 52
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.
Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52
Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
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.
Change From Baseline in Short Form Health Survey-36 (SF-36) Score
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.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
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.
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
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.
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score
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
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Number of Participants with Antibodies to BIIB059

Full Information

First Posted
May 17, 2021
Last Updated
June 13, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT04895241
Brief Title
A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Acronym
TOPAZ-1
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
March 28, 2025 (Anticipated)
Study Completion Date
September 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to demonstrate efficacy of BIIB059 (litifilimab) compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity. Secondary objectives of this study are to demonstrate early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of BIIB059 compared with placebo in reducing oral corticosteroid (OCS) use; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of BIIB059 compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of BIIB059 compared with placebo in reducing OCS use; to assess the difference between BIIB059 and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of BIIB059 in participants with active SLE; and to evaluate immunogenicity of BIIB059 in participants with active SLE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Lupus, SLE, CLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BIIB059 High Dose
Arm Type
Experimental
Arm Description
Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059, subcutaneously (SC) every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
Arm Title
BIIB059 Low Dose
Arm Type
Experimental
Arm Description
Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of BIIB059, SC Q4W, up to Week 48 with an additional dose at Week 2.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who are receiving background nonbiologic lupus SOC therapy will receive BIIB059 matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
Intervention Type
Drug
Intervention Name(s)
BIIB059 (litifilimab)
Other Intervention Name(s)
litifilimab
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
Description
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.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an SRI-4 Response at Week 24
Description
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.
Time Frame
Week 24
Title
Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
Description
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.
Time Frame
Week 52
Title
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
Description
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.
Time Frame
Week 40 to Week 52
Title
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
Description
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.
Time Frame
Week 16
Title
Annualized Flare Rate Through Week 52
Description
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.
Time Frame
Up to Week 52
Title
Change from Baseline in Physician's Global Assessment (PGA) Visual Analog Scale (VAS) Score by Visit
Description
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.
Time Frame
Up to Week 52
Title
Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
Description
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.
Time Frame
Up to Week 52
Title
Time to Onset of SRI-4 Response Sustained Through Week 52
Description
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.
Time Frame
Up to Week 52
Title
Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
Description
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.
Time Frame
Up to Week 52
Title
Percentage of Participants with Joint-50 Response by Visit
Description
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.
Time Frame
Up to Week 52
Title
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit
Description
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.
Time Frame
Up to Week 52
Title
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤ 1 by Visit
Description
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.
Time Frame
Up to Week 52
Title
Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit
Description
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.
Time Frame
Up to Week 52
Title
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)
Description
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.
Time Frame
Up to Week 52
Title
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
Description
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.
Time Frame
Up to Week 52
Title
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
Description
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.
Time Frame
Up to Week 52
Title
Percentage of Participants who Achieved LLDAS at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52
Time Frame
Week 52
Title
Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
Description
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.
Time Frame
Up to Week 52
Title
Change From Baseline in Short Form Health Survey-36 (SF-36) Score
Description
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.
Time Frame
Up to Week 52
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Description
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.
Time Frame
Up to Week 52
Title
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Description
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.
Time Frame
Up to Week 52
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score
Description
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
Time Frame
Up to Week 52
Title
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Week 52
Title
Number of Participants with Antibodies to BIIB059
Time Frame
Up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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: Antimalarials as stand-alone treatment Antimalarial treatment in combination with OCS and/or a single immunosuppressant Treatment with OCS and/or a single immunosuppressant 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 hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody [anti-HBc]). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Biogen Clinical Trial Center
Phone
866-633-4636
Email
clinicaltrials@biogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Biogen Clinical Trial Center
Email
clinicaltrials@biogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Stafford
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Viña del Mar
State/Province
Valparaíso
ZIP/Postal Code
571
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Lagos
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500010
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clermont-Ferrand cedex 1
State/Province
Puy De Dome
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
4763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
5030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Benito Juárez
State/Province
Ciudad De México
ZIP/Postal Code
03720
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cuernavaca
ZIP/Postal Code
62290
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Durango
ZIP/Postal Code
34080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-707
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
53-224
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung City
State/Province
Niaosong District
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org/
Links:
URL
https://www.topazlupusstudy.com/
Description
Click here to learn more about this trial, visit our study website

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

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