A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POETYK-SLE-2)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Active Systemic Lupus Erythematosus (poetyk-sle-2)
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Age: Between 18 Year(s) - 75 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Diagnosed with Active Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit
- At least one of the following SLE background therapies (immunosuppressant and/or
antimalarial) is required for = 12 weeks before the screening visit, must be at a stable dose
for = 8 weeks before the screening visit, and dose must remain stable through duration of study
i) Immunosuppressants (participants can only be on ONE immunosuppressant)
- azathioprine (maximum 200 mg/day)
-6-mercaptopurine (6-MP) (maximum 200 mg/day)
- methotrexate (MTX: maximum 25 mg/week; dose and route of administration of MTX may not be changed for 8 weeks before the screening visit and throughout study participation)
- methotrexate (MTX: maximum 25 mg/week; dose and route of administration of MTX may not be changed for 8 weeks before the screening visit and throughout study participation).
- leflunomide (maximum 20 mg/day)
- tacrolimus (maximum 0.2 mg/kg/day).
- mizoribine (maximum 150 mg/day)
- mycophenolate mofetil (MMF)/mycophenolic acid (MPA): Note: Participants who are receiving MMF may participate in the study only if administered as a maintenance therapy and up to a maximum of 2,000 mg/day (or equivalent MPA dose 1,440 mg/day); in participants of African ancestry, 3,000 mg/day (or equivalent MPA dose 2,160 mg/day) is acceptable
ii) Antimalarials:
- chloroquine, hydroxychloroquine, or quinacrine; monotherapy is permitted if the following minimum doses are met: chloroquine 250 mg QD, hydroxychloroquine 400 mg QD, or quinacrine 100 mg QD, or if the participant is on the maximum recommended dose based on weight-based dosing
- Participants can only be on ONE antimalarial but can be on both an immunosuppressant and an antimalarial. - Oral corticosteroid (prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose cannot exceed 30 mg/day at screening
- Topical CS (low to moderate potency) is permitted, but a stable regimen must be followed and cannot be used on an as-needed basis.
- Inhaled CS for non-lupus conditions is permitted and will not count against the maximum CS dose.
- Oral and/or topical non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin orcyclooxygenase-2 inhibitors) are allowed, as a stable therapy or on an as-needed basis
You may not be eligible for this study if the following are true:
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- Medical Conditions such as:
-Diagnosis of drug-induced SLE rather than idiopathic SLE
-Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren’s syndrome are not excluded.
- SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
-Concomitant fibromyalgia, chronic fatigue syndrome, or chronic pain syndrome if the symptoms or therapy are likely to significantly impact the assessment or interpretation of SLE disease manifestations and activity based on discussion with eligibility reviewers.
-Confirmed antiphospholipid syndrome (APS) - If there has been a thrombotic event or pregnancy morbidity within 12 months before screening
- If there has been a thrombotic event or pregnancy morbidity more than 12 months before screening and participant is not maintained on appropriate therapy.
- History of catastrophic antiphospholipid syndrome(CAPS)
- Active or unstable lupus neuropsychiatric manifestations
- Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS are excluded. Participants with prior, controlled renal disease are allowed. Stability of renal disease must be documented over the past 6 months
- Exposure to prohibited immunomodulatory drugs (eg, cyclosporine) or biologic drugs (eg, rituximab, belimumab, tocilizumab, etc) within the washout period
- Medical Conditions such as:
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