Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Exclusion Criteria

• •Lupus nephritis if any of the following are present: urine protein creatinine ratio ≥ 2000 mg/g (or equivalent) at screening, OR requiring induction therapy currently or within 1 year prior to screening, OR histological evidence (if available) of diffuse proliferative glomerulonephritis within 12 weeks prior to screening.
• •Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
• •Currently present or within 1 year prior to screening a diagnosis of any chronic inflammatory disease other than SLE (eg, rheumatoid arthritis) which would interfere with SLE disease assessment.
• •History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for \> 2 weeks within 4 months prior to screening.
• •Active infection (including chronic or localized infections) for which anti-infectives are indicated currently or within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.
• •Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.
• •Positive test for tuberculosis during creening defined as: either a positive or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD) (≥5 mm of induration at 48 to 72 hours after test is placed).
• •Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb). A history of hepatitis B vaccination without history of hepatitis B infection (ie, positive hepatitis B surface antibody (HBsAb), negative HBsAg and negative HBcAb) is allowed.
• •Positive for hepatitis C antibody.
• •Known history of HIV or positive HIV test at screening.
• •Presence of 1 or more significant concurrent medical conditions, including but not limited to the following:
• •* poorly controlled diabetes (hemoglobin A1C \> 7) or hypertension
• •* symptomatic heart failure (New York Heart Association class III or IV)
• •* myocardial infarction or unstable angina pectoris within the past 12 months prior to screening
• •* severe chronic pulmonary disease requiring oxygen therapy
• •* multiple sclerosis or any other demyelinating disease
• •Any history of malignancy with the following exceptions:
• •resolved non-melanoma skin cancers \> 5 years prior to screening
• •resolved cervical carcinoma \> 5 years prior to screening
• •resolved breast ductal carcinoma in situ \> 5 years of screening
• •Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent within 6 months prior to screening or sirolimus within 4 weeks prior screening.
• •Currently receiving or had treatment with a Janus kinase (JAK) inhibitor within 3 months or less than 5 drug half-lives (whichever is longer) prior to screening.
• •Currently receiving or had treatment with an immune checkpoint inhibitor (eg, programmed death 1 \[PD-1\] inhibitor, programmed death ligand 1 \[PD-L1\] inhibitor, cytotoxic T-lymphocyte associated protein 4 \[CTLA-4\] inhibitor).
• •Note: Abatacept is not considered a CTLA-4 inhibitor and is referred to below.
• •Currently receiving or had treatment within 12 months prior to screening with T-cell depleting agents (eg, antithymocyte globulin, Campath).
• •Currently receiving of had treatment with an interleukin 2 (IL-2) based therapy (eg, Proleukin).
• •Current or previous treatment with a biologic agent with immunosuppressive/immunomodulatory activity as follows: rituximab within 6 months prior to screening; abatacept and belimumab within the past 3 months prior to screening; other biologics within \< 5 drug half lives prior to screening.
• •Participants who have received intraarticular, intralesional, or intramuscular corticosteroids within 2 weeks prior to screening or intravenous corticosteroids within 6 weeks prior to screening.
• •Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines during the treatment period and up to 6 weeks after the end of treatment period in the study.
• •Currently receiving treatment in another investigational device or drug study.
• •Ending a treatment with an investigational drug or investigational device less than 3 months or 5 half-lives from the last dose of the investigational drug (whichever is longer) at screening.