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) - 70 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Able and willing to provide written informed consent (signed and dated) to participate in this study and comply with all requirements in the study protocol
  2. Diagnosed with SLE =6 months prior to screening
  3. Currently receives at least 1 of the following:
     • A stable dose of oral corticosteroid (=40 mg/day prednisone or equivalent) for a minimum of 2 weeks prior to signing of the informed consent form (ICF) at the Screening Visit.
     • And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine)
     • And/or no more than 1 of the following conventional Disease-modifying antirheumatic drugs (DMARDS):
       • Azathioprine =200 mg/day
       • Mycophenolate mofetil =2 g/day or mycophenolic acid =1.44 g/day
       • Oral, subcutaneous, or intramuscular (IM) methotrexate =20 mg/week.
  4. Women of childbearing potential (WOCBP) must agree to adhere to highly effective methods of contraception for the entirety of the study and for 30 days after the last dose of study drug
  5. Nonsterilized male patients who are sexually active with WOCBP must agree to use highly effective methods of contraception for the entirety of the study and for 90 days after the last dose of study drug

  
  

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

• 1. Current or history within 1 year of screening of alcohol or drug abuse (excluding cannabis) based on Investigator’s clinical judgment.
  2. Pregnant, lactating, or planning to get pregnant during the study period and for 1 month after study completion or discontinuation
  3. Unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) or a cardiac hospitalization within the last 3 months
  4. Patient has planned major surgery during the study period
  5. Drug-induced SLE or other autoimmune diseases
  6. Active, proliferative lupus nephritis that in the Investigator’s opinion may require treatment not allowed by the protocol
  7. Active severe or unstable neuropsychiatric SLE including, but not limited to the following: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending or transverse myelitis, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; new seizures; cerebellar ataxia; and mononeuritis multiplex
  8. History of or current diagnosis of catastrophic antiphospholipid syndrome within 12 months prior to signing the consent. Antiphospholipid syndrome adequately controlled by anticoagulant therapy (other than warfarin) for at least 3 months is acceptable. Positive antiphospholipid antibodies without clinical symptoms are not exclusionary.
  9. History of any recurrent non-SLE disease that required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 52 weeks prior to signing the consent. Treatment with corticosteroids for conditions that are not expected to recur (eg, poison ivy) is not excluded.
  10. Receipt of any Investigational Products (small molecule or biologic agent) within 3 months or 5 half-lives, whichever is greater, prior to signing of the ICF, or is currently enrolled in an investigational study
  11. Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF
  12. Receipt of B cell-depleting therapy (including but not limited to obinutuzumab, ocrelizumab, or rituximab) <6 months prior to signing the ICF or, if therapy was administered >6 months prior to signing the ICF, absolute B cell less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)
  13. Has received any therapeutic agent targeted to IL-12, IL-17, or IL-23 within 6 months or any tumor necrosis factor alpha inhibitor(s) within 12 weeks of prior to signing the consent
  14. Has received JAK inhibitors (eg, baricitinib, tofacitinib) or TYK2 inhibitors within 12 weeks of prior to signing the consent
  15. Is currently receiving PPIs such as omeprazole or esomeprazole. It is acceptable to substitute a histamine 2 receptor blocking drug, or oral antacids prior to Study Day 1.
  16. Receipt of any of the following:
      • Intra-articular, intramuscular (IM), or IV corticosteroids within 6 weeks prior to Day 1
      • Any live or attenuated vaccine within 4 weeks prior to signing the consent (administration of killed or recombinant vaccines is acceptable).
      • Blood transfusion within 4 weeks prior to signing the ICF
  17. . Known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predisposes the patient to infection
  18. Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years), or ophthalmic herpes (ever)
      • Active herpes zoster infection within 12 weeks of prior to signing the ICF
      • Active herpes simplex virus within 4 weeks of Day 1
  19. Any of the following:
      • Currently active, clinically significant infection of any kind
      • Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) within 8 weeks prior to signing the ICF (chronic fungal nail infections are allowed)
      • Any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF
      • Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 1
  20. Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for the following:
      • Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy >3 months prior to Week 0 (Day 1)
      • Cervical cancer in situ treated with curative therapy with apparent success >1 year prior to Week 0 (Day 1)