Systemic Lupus Erythematosus
Conditions
Interventions
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to evaluate the efficacy and safety of BIIB059 in participants >= 18 years of age with active SLE, including
a double-blind, placebo-controlled treatment period of 52 weeks
and an SFU period (off-treatment) of 24 weeks.
Sponsors
Matsuda Naoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 EULAR/ACR classification criteria for SLE, at screening by a qualified physician. -Participant has a modified 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 C3 and/or 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. -Participants 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 immunosuppressant -Treatment with OCS and/or immunosuppressants
Exclusion criteria
Exclusion criteria: -History of or positive test result for HIV. -Current hepatitis C infection (defined as positive HCV antibody and detectable HCV RNA). -Current hepatitis B infection (defined as positive for HBsAg and/or total 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, 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 mL/min/1.73 m^2) calculated using the abbreviated Modification of Diet in Renal Disease equation. -Any active skin conditions other than 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. -Use of oral prednisone (or equivalent) above 20 mg/day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieved an SRI-4 response at Week 52. The composite endpoint SRI-4 is defined by the following criteria: -A reduction from Baseline of >= 4 points in SLEDAI-2K -No new organ system affected, as defined by no new organ system with 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 changes to protocol-specified medication rules. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Proportion of participants who achieved an SRI-4 response at Week 24. -Proportion of participants with at least 4 joints (both swollen and tender) at Baseline who achieved a Joint-50 response at Week 52. A joint is defined as a joint that is both swollen and tender. Joint-50 is defined as at least 50% reduction in total active joint count from Baseline based on the 28-joint count assessment. -Proportion of participants with OCS >= 10 mg/day at Baseline who have OCS reduction to = 10 at Baseline who achieved a CLASI-50 response at Week 16. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. -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 PGA-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. -Proportion of participants who achieved a BICLA response by visit. The BILAG Disease Activity Index is an instrument that evaluates SLE activity in a number of organ systems, a separate alphabetic score is assigned to each organ system, the following definitions: -BILAG-2004 grade A: severe disease activity -BILAG-2004 grade B: moderate disease activity -BILAG-2004 grade C: mild disease. -BILAG-2004 grade D: system previously affected but now inactive. -BILAG-2004 grade E: system never involved. BICLA is a composite endpoint defined as follows: 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 worsening in the SLEDAI-2K total score c | — |
Countries
Argentina, Belgium, Canada, China, Colombia, Czech, Germany, Hungary, Israel, Italy, Japan, Netherlands, Puerto Rico, Romania, Serbia, United Kingdom, United States
Contacts
Public ContactBiogen Japan Medical Information
Biogen Japan Ltd.
Outcome results
None listed