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

  • STATUS
    Recruiting
  • End date
    Jun 19, 2024
  • participants needed
    320
  • sponsor
    Amgen
Updated on 24 September 2021

Summary

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active SLE.

Details
Condition Active Systemic Lupus Erythematosus
Treatment Placebo, Standard of Care, Efavaleukin Alfa
Clinical Study IdentifierNCT04680637
SponsorAmgen
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Lupus nephritis with urine protein creatinine ratio 3000 mg/g (or equivalent) at screening or having required induction therapy within 1 year 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 inflammatory joint or skin disease other than SLE (confirmed by the investigator) which would interfere with SLE disease assessment based on investigator judgement
Active infection (including chronic or localized infections) for which anti-infectives were indicated 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
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 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, PD-1 inhibitor, PD-L1 inhibitor, 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) or recombinant IL-2 (eg, Proleukin)
Current or previous treatment with a biologic agent 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
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