efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus

Conditions: Active Systemic Lupus Erythematosus

Summary: the primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.


Eligibility criteria:
inclusion criteria: * participant has provided informed consent prior to initiation of any study specific activities/procedures. * participant is aged between 18 and 75. * fulfills classification criteria for systemic lupus erythematosus (sle) according to the 2019 european league against rheumatism (eular)/american college of rheumatology (acr) classification criteria for sle with antinuclear antibody ≥ 1:80 by immunofluorescence on hep-2 cells being present at screening. * hybrid sledai score ≥ 6 points with a "clinical" hsledai score ≥ 4 points. the "clinical" hsledai is the hsledai assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters. * british-isles lupus assessment group (bilag) index score (bilag 2004) of ≥ 1 a item or ≥ 2 b items. * must be taking ≥ 1 of the following sle treatments (or regional equivalent): hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil, azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or ocs. a participant may enter the study on ocs alone (prednisone ≥ 10 mg/day or equivalent) only if the participant has previously documented trial of anti-malarial or immunosuppressant treatment for sle. participants must be on a stable dose for ≥ 8 weeks prior to screening for all antimalarials and immunosuppressants, with the exception of ocs doses which must be stable for ≥ 2 weeks prior to screening. * for participants taking ocs, dose must be ≤ 20 mg/day of prednisone or ocs equivalent, and the dose must be stable at baseline visit and for ≥ 2 weeks prior to screening visit. * stability of sle treatments: ocs and other immunosuppressants/immunomodulator agents and doses must be stable since screening visit. * disease activity: active disease as indicated by clinical hsledai score ≥ 4 must be observed (clinical hsledai score is the hsledai assessment score without the inclusion of points attributable to laboratory results including urine and immunologic parameters). 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.