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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
EU CTIS ID: 2023-505696-74-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be diagnosed with 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 Index200 (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
- Other protocol defined inclusion criteria may apply
You likely can't join if
- History of or positive test result for human immunodeficiency virus (HIV).
- Use of oral prednisone (or equivalent) above 20 mg/day.
- Other protocol defined Exclusion criteria may apply
- 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 HBsAg and/or positive for total anti- HBc). with positive reflex HBV DNA).
- History of severe herpes infection
See the full eligibility criteria
- Participant must be diagnosed with 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 Index200 (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
- Other protocol defined inclusion criteria may apply
- History of or positive test result for human immunodeficiency virus (HIV).
- Use of oral prednisone (or equivalent) above 20 mg/day.
- Other protocol defined Exclusion criteria may apply
- 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 HBsAg and/or positive for total 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, 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 <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 druginduced lupus.
- History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome.
- Active neuropsychiatric SLE.
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Israel
- United States
- Canada
- China
- Argentina
- Serbia
- United Kingdom
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Israel; United States; Canada; China; Argentina and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.