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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005775-12-FR

Enrollment

540

Registered

2021-08-26

Start date

2022-04-01

Completion date

Unknown

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic lupus erythematosus MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Not applicable Product Code: BIIB059 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not applicable Current Sponsor code: BIIB059 Other descriptive name: Humanised IgG1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 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, a. Antimalarials as stand-alone treatment b. Antimalarial treatment in combination with OCS and/or immunosuppressants c. Treatment with OCS and/or immunosuppressants Note: Other protocol defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 528 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: 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 Exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to demonstrate efficacy of BIIB059 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 Objective: The secondary objectives are: * to demonstrate: - early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, receiving SOC in reducing disease activity; - organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, receiving SOC in reducing joint disease activity; - effect of BIIB059 compared with placebo in reducing oral corticosteroid (OCS) use; - organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE receiving SOC in reducing skin disease activity and 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 and OCS use - the safety, tolerability and immunogenicity of BIIB059 in participants with active SLE; to assess the difference between BIIB059 and placebo on participant-reported HRQoL, symptoms, and impacts of SLE; ;Primary end point(s): Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52.;Timepoint(s) of evaluation of this end point: Week 52	—

Measure

Time frame

Main Objective: The primary objective of this study is to demonstrate efficacy of BIIB059 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 Objective: The secondary objectives are: * to demonstrate: - early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, receiving SOC in reducing disease activity; - organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, receiving SOC in reducing joint disease activity; - effect of BIIB059 compared with placebo in reducing oral corticosteroid (OCS) use; - organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE receiving SOC in reducing skin disease activity and 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 and OCS use - the safety, tolerability and immunogenicity of BIIB059 in participants with active SLE; * to assess the difference between BIIB059 and placebo on participant-reported HRQoL, symptoms, and impacts of SLE; ;Primary end point(s): Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52.;Timepoint(s) of evaluation of this end point: Week 52

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Secondary

Measure	Time frame
Secondary end point(s): 1. Percentage of Participants Who Achieved an SRI-4 Response at Week 24 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 =7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52 4. 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 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 = 1 by Visit 13. Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit 14. 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) 15. Percentage of Participants With Baseline OCS =10 mg/day Who Achieved =7.5 mg/day at Week 52 16. Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score 17. Change From Baseline in Short Form Health Survey-36 (SF-36) Score 18. Change From Baseline in Functional Assessme	—

Measure

Time frame

Secondary end point(s): 1. Percentage of Participants Who Achieved an SRI-4 Response at Week 24 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 =7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52 4. 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 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 = 1 by Visit 13. Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit 14. 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) 15. Percentage of Participants With Baseline OCS =10 mg/day Who Achieved =7.5 mg/day at Week 52 16. Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score 17. Change From Baseline in Short Form Health Survey-36 (SF-36) Score 18. Change From Baseline in Functional Assessme

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Countries

Australia, Brazil, Bulgaria, Chile, France, Greece, Korea, Republic of, Mexico, Peru, Philippines, Poland, Russian Federation, Spain, Sweden, Taiwan, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026