Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Systemic Lupus Erythematosus
• Age: Between 18 Year(s) - 75 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Diagnosed with SLE at least 24 weeks before the screening visit
  2. 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 must remain stable until randomization and throughout study participation:
  • Immunosuppressants (participants can only be on ONE immunosuppressant):
  1. azathioprine (maximum 200 mg/day).
  2. 6-mercaptopurine (6-MP) (maximum 200 mg/day).
  3. 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).
  4. leflunomide (maximum 20 mg/day).
  5. tacrolimus (maximum 0.2 mg/kg/day)
  6. mizoribine (maximum 150 mg/day)
  7. mycophenolate mofetil (MMF)/mycophenolic acid (MPA)
  • 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.
  3. OCS (prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for = 2 weeks before the screening visit, cannot exceed 30 mg/day at screening
  4. Oral and/or topical non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin or cyclooxygenase-2 inhibitors) are allowed, as a stable therapy or on an as-needed basis, provided they are taken within the dose and frequency ranges on their respective labels
  5. Opioid analgesics are allowed provided the doses administered do not exceed 30 mg of morphine per day or equivalent
  6. Participants must be 18 (or the legal age of majority in the jurisdiction in which the study is taking place if greater than 18) to 75 years of age, inclusive, at the time of signing the informed consent
  7. Require the use of alternative and/or additional contraception methods
  • Women who are not of childbearing potential (as defined in Appendix 4) are exempt from contraceptive requirements
  • WOCBP must agree to use highly effective (with a failure rate of < 1% per year) method(s) of contraception
  • Male participants should maintain their usual practice with regard to contraception (if any); no additional contraceptive measures are required to be used

  
  

You may not be eligible for this study if the following are true:

• 
  Medical Conditions
  
  
  1. Diagnosis of drug-induced SLE rather than idiopathic SLE
  2. 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.
  3. SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded
  4. Antiphospholipid syndrome (APS) with any of the following
  • Confirmed diagnosis of APS
  1. if there has been a thrombotic event or pregnancy morbidity within 12 months before screening
  2. 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)
  • Positive result for antiphospholipid antibodies at screening and history of thrombosis or pregnancy mortality without diagnosis of APS, if at increased risk for thrombosis as assessed by the EEAC
  5. Active or unstable lupus neuropsychiatric manifestations
  6. Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS are excluded.
  
  Medical Condition and History
  
  
  7. Women who are pregnant, lactating, breastfeeding, or planning pregnancy during the study period
  8. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than adequately treated cutaneous basal cell or squamous cell carcinoma with no evidence of recurrence).
  9. Hospitalization for heart failure within 24 weeks before screening
  10. Acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) and/or any significant cerebrovascular disease within 24 weeks before screening
  
  Prior and Concomitant Therapy:
  
  
  11. Exposure to prohibited immunomodulatory drugs (eg, cyclosporine) or biologic drugs (eg, rituximab, belimumab, tocilizumab, etc) within the washout period
  12. Taking more than 1 immunosuppressant at screening
  13. OCS (prednisone or equivalent) = 30 mg per day. Further specifications are as follows:
  • OCS monotherapy (ie, without a concomitant immunosuppressant and/or antimalarial) is prohibited
  • Intramuscular, intra-articular, intrabursal, and intravenous (IV) CS use is prohibited within 6 weeks before screening
  • Modified-release CS formulations are prohibited
  • High-potency topical steroid formulations are prohibited
  14. Exposure to investigational agent(s) taken within 12 weeks or 5 half-lives before screening, whichever is longer
  15. Use of botanical preparations (eg, herbal supplements or traditional Chinese medicines derived from plants, minerals, or animals) within 4 weeks prior to screening
  
  Infection and/or Immune-related Exclusions
  
  
  16. Any of the following tuberculosis (TB) criteria:
  • History of active TB prior to screening visit, regardless of completion of adequate treatment.
  • Any imaging of the chest (eg, chest x-ray, chest computed tomography scan) obtained during the screening period or at any time within 6 months prior to Screening, with documentation showing evidence of current active or history of active pulmonary TB
  17. Evidence of, or positive testing for, hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV) at screening
  18. Recent herpes zoster or herpes simplex infection or history of serious herpes zoster or herpes simplex infection
  19. Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria)
  20. History of congenital or acquired immunodeficiency
  21. History or evidence of active infection and/or febrile illness not related to SLE within 14 days prior to Day 1
  22. Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization.
  23. Administration of a live vaccine within 60 days of randomization or at any time during treatment or within the 60 days following last dose of deucravacitinib.