Beurteilung der Wirksamkeit und Sicherheit von Efavaleukin alfa bei Personen mit aktivem systemischem Lupus erythematodes, die nicht ausreichend auf die Standardtherapie angesprochen haben

Drug: Efavaleukin Alfa;Drug: Placebo;Other: Standard of Care

Gender: All
Maximum age: 75 Years
Minimum age: 18 Years

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