Lupus Erythematosus, Systemic
Conditions
Brief summary
The main objective of this study is to assess the safety, tolerability and pharmacokinetics of orally administered BI 705564 in patients with systemic lupus erythematosus
Interventions
DRUGBI 705564
Film-coated Tablet
DRUGPlacebo
Film-coated Tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years at screening. * Diagnosis of systemic lupus erythematosus (SLE) at least 6 months prior to screening according to SLICC 2012 criteria; at least 4 criteria must be documented. * Positive test results for anti-nuclear antibody (ANA) (human epithelial cell-2 ANA greater than or equal to \[\>=\] 1:80) and/or anti-dsDNA antibody at the Screening visit. To be performed by Central Laboratory. * At screening visit a clinical Systemic Lupus Erythematosus Disease Activity Index (2K), (SLEDAI 2K) score of ≥ 4 points. The clinical score is the SLEDAI 2K assessment score without the inclusion of points attributable to any blood laboratory results including immunologic measures. Neurologic descriptors of the SLEDAI 2K are not counted towards the SLEDAI 2K study entry criteria. * Has received all scheduled vaccines according to local guidelines and Investigator judgement. Live or live-attenuated virus vaccines are not permitted within 1 month prior to screening or during screening. For all other vaccines there must be at least 2 weeks between the vaccination(s) and the date of randomization at Day 1. * For male patients: Men who are permanently sterile by bilateral orchidectomy are not required to use contraception. Men whose partner (or potential partner) is a women of childbearing potential\*, for the duration of the study (including 30 days after the last dose of study drug) must use a condom. For female patients: Women of childbearing potential\* must be willing and able to use a double-barrier contraception (barrier in the meaning of method) with at least one highly effective method of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of the study including 4 weeks after the last dose of study drug. Medically accepted methods of contraception in this study are: * Combined (oestrogen and progestogen containing) hormonal birth control associated with inhibition of ovulation in combination with male condom. * Progestogen-only hormonal birth control associated with inhibition of ovulation in combination with male condom. * Intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) in combination with male condom Or * The patient must have only vasectomized sexual partner(s) (vasectomy at least 1 year prior to enrolment), Or * The patient must follow true abstinence from male-female sex. This is defined as being in line with the preferred and usual lifestyle of the patient. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods; declaration of abstinence for the duration of exposure to IMP; and withdrawal are not acceptable. * A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
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. * Patients with APS antibodies may be included unless they are excluded due to exclusion anti-coagulation medication (see
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint to assess safety and tolerability of BI 705564 is the number of patients with drug related Adverse Events | Up to 73 Days |
Secondary
| Measure | Time frame |
|---|---|
| Number and severity of Adverse Events | Up to 87 Days |
| Number of patients with Adverse Events | Up to 87 Days |
| Number of patients with Serious Adverse Events | Up to 87 Days |
| Change from baseline in BILAG | Up to 87 Days |
| Change from baseline in SLEDAI-2K | Up to 87 Days |
Outcome results
None listed