BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

Exclusion Criteria

• •Active clinically significant neuropsychiatric SLE or any BILAG A score for a neuropsychiatric manifestation or in the ophthalmic domain within the past 12 months.
• •Drug-induced Lupus.
• •Other autoimmune diseases such as Rheumatoid Arthritis, Crohn's, scleroderma, psoriasis, Celiac disease, Graves'disease, thyroid disease, with the following exceptions:
• •* Sjögren syndrome if this is secondary to their SLE is permissible.
• •* Patients with features of mixed connective tissue disease may be included if this is secondary to their SLE and is, in the Investigator's opinion not considered to be significant.
• •* Diabetes if this is considered by the Investigator to be well controlled and there is no evidence of retinopathy or nephropathy.
• •Initiation or change in dose of anti-malarial treatment after the screening visit.
• •Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin, etc.) or high dose antiplatelet therapy.
• •Within 2 weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 15 mg daily prednisone or an equivalent dose, use of any injectable corticosteroids, or change in dose of corticosteroids. For patients continuing on oral corticosteroids the dose must be stable for 4 weeks prior to randomisation.
• •After consent, initiation or change in dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker.
• •Initiation of regular nonsteroidal anti-inflammatory drugs (NSAIDs) use within 2 weeks prior to Screening. Regular use defined as 3 consecutive days.
• •Within 2 months prior to Screening or during Screening: initiation of or change in dose of methotrexate, mycophenolate (mofetil or sodium), or azathioprine.
• •Within 4 weeks prior to Screening or during Screening, use of cyclosporine or tacrolimus.
• •Within 3 months prior to Screening or during Screening: use of cyclophosphamide or chlorambucil.
• •Within 3 months prior to Screening or during Screening, use of leflunomide, abatacept, anti-tumor necrosis factor alpha agents, intravenous immunoglobulin, plasmapheresis, or other disease modifying, immunosuppressive, or immunomodulatory therapies not otherwise specified in protocol.
• •Within 12 months prior to screening or during screening: use of anti-CD20 or anti-CD22 biological medications or any other B cell-depleting medication. If a patient has had rituximab more than 6 months ago and has a normal CD-19 count then they may be included. A historic local lab value may be used to confirm this. For B-cell modulating therapies including atacicept these are excluded within 6 months apart from blisibimod and belimumab which are excluded within 3 months. Type I-IFN interferon antagonists such as anifrolumab are excluded within 6 months.
• •Ustekinumab within 6 months of screening.
• •JAK inhibitors within the last 12 months before screening visit.
• •Active clinically significant viral, bacterial or fungal infection, or any serious episode of infection requiring hospitalization within the last 6 months. If the infection is not active or clinical significant or required hospitalization the patient may be included as long as they have not taken antibiotics more than 4 weeks prior to screening.
• •Chronic Hepatitis B, HIV, history of active TB.
• •* A patient with an indeterminate or positive TB test result at screening may be enrolled if a thorough investigation by a qualified physician determines that they do not have active TB or untreated latent TB.
• •* In the case of Anti-HBc antibody positive result but HBs antigen negative then Hepatitis B DNA can be measured at a local lab. If Hepatitis B DNA is positive the patient will be excluded, if Hepatitis B DNA is negative then the patient can be included.
• •Immunoglobulin G (IgG) less than the lower limit of normal at screening.
• •Estimated glomerular filtration rate of less than (\<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) by the CKD-EPI (2009) Creatinine Equation, or recent decline in kidney function, defined as decrease within the last 2 months prior to screening:
• •\-- as a reduction in eGFR of \>=20% and below lower limit of normal (90 mL/ min/ 1.73m2).
• •Proteinuria \> 2 g/d or urine protein/urine creatinine ratio \>2 mg/mg at screening.
• •Clinically significant other renal disease based on investigator judgement (e.g. postinfectious GN, pyelonephritis)
• •Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned during the trial.
• •Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
• •Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
• •Previous randomisation into this trial.
• •Currently enrolled in another investigational device or drug trial,
• •* or receiving other investigational treatment(s).
• •Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
• •Women who are pregnant, nursing, or who plan to become pregnant in the timeline of the trial.
• •Uncontrolled hypertension or other haematologic conditions (except SLE). Diabetes mellitus if poorly controlled according to investigator or known diabetic nephropathy or retinopathy.
• •Thrombocyte count at screening 70,000/μl or less.
• •Known hypersensitivity to the study drug or their excipients.
• •Patients with known ocular complications apart from dry eyes and mild cataracts in the opinion of an ophthalmologist.
• •A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial.
• •History of pancreatitis of any aetiology