Lupus Systemic Lupus Erythematosus
Conditions
Interventions
Participants treated with background nonbiologic lupus SOC
therapies will be randomized 1:1:1 to receive BIIB059 450 mg,
BIIB059 225 mg, or placebo SC Q4W with an additional dose at
Week 2.
Sponsors
Biogen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: - Participant must be diagnosed with SLE at least 24weeks prior to screening and must meet the 2019European 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-200 (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. - 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, a). Antimalarials as stand-alone treatment. b). Antimalarial treatment in combination with OCS and/or a single immunosuppressant. c). Treatment with OCS and/or a single immunosuppressant. Note: Other protocol defined inclusion criteria may apply.
Exclusion criteria
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, such as adding intravenous (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of Participants Who Achieved an SRI-4 Response at Week 2. Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52. 3. Percentage of Participants with OCS >=10 milligrams per day (mg/day) at Baseline Who Have OCS Reduction to =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 5. Annualized Flare Rate Through Week 52 6. Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog Scale (VAS) Score by Visit 7. Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit 8. Time to Onset of SRI-4 Response Sustained Through Week 52 9. Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit 10. Percentage of Participants with Joint-50 Response by Visit 11. Percentage of Participants with Baseline CLASI-A Score >=10 Who Achieved a CLASI- 20, -50, -70, or -90 Response by Visit 12. Percentage of Participants with Baseline CLASI-A Score >=10 Who Achieved a CLASI-A Score of = 3, >= 5, and >= 7 consecutive visits in LLDAS up to and including Week 52. 17. Proportion of participants who achieved LLDAS at Week 52.15. Percentage of Participants with Baseline OCS >=10 mg/day Who Achieved | — |
Countries
Netherlands
Outcome results
None listed