A randomized double-blind placebo-controlled study of ALPN-101 in systemic lupus erythematosus.

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) - 65 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosis of SLE for greater than or equal to 6 months prior to Screening
    2. Subjects must have anti-nuclear antibodies (ANA) and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test at Screening
    3. Subjects must demonstrate active SLE at Screening
    4. Stable, appropriate standard of care for SLE
    5. Must agree to use highly effective methods of contraception methods during study treatment and for 3 months or less following
    6. Must be able to provide written informed consent

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

    1. Life-threatening or organ system-threatening SLE activity that is sufficiently active that it is expected to require increase in treatment during the study
    2. Proteinuria consistent with nephrotic syndrome
    3. Active lupus-related neuropsychiatric disease at Screening or Baseline
    4. Drug-induced lupus
    5. Any serious health condition, which, in the opinion of the Investigator or Sponsor, would place the subject at undue risk from the study or would confound interpretation of safety or efficacy outcomes
    6. Recent serious or ongoing infection; risk or history of serious infection
    7. Receipt of live vaccination 8 weeks or less prior to Baseline, or expected to require live vaccines during the study
    8. Screening laboratory abnormalities
    9. History of new, ongoing, or recurrent malignancy 5 years or less prior to first dose of study drug except basal cell carcinoma of the skin, squamous cell skin cancer
    10. Pregnant or breastfeeding at the time of screening, or plans to become pregnant 3 months or less following the last dose of study drug
    11. Fulfills diagnostic criteria for another rheumatic disease that overlaps with SLE
    12. Prior diagnosis of, or fulfills diagnostic criteria for, another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
    13. Diagnosis of fibromyalgia
    14. Functional class IV SLE
    15. Serious SLE disease activity
    16. Ongoing participation in another therapeutic clinical trial
    17. Known hypersensitivity to ALPN-101, components thereof, or excipients contained in the drug formulation



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