msc2364447c phase 1b in systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: the primary purpose of this phase 1b double-blind, randomized, placebo-controlled trial is to evaluate the safety, tolerability, pharmacokinetic (pk), and biological effect of msc2364447c administered for 4 weeks in systemic lupus erythematosus subjects (sle).


Eligibility criteria:
inclusion criteria: * male or female of 18 to 65 years of age * diagnosis of systemic lupus erythematosus (sle) (at least 4 of the 11 american college of rheumatology \[acr\] classification criteria for sle) of at least 6 months duration at the screening visit * 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 (\>= 30 international units per milliliter \[iu/ml\]) at the screening visit * at least 1 sle disease manifestation (assessed by systemic lupus erythematosus disease activity index-2000 \[sledai-2k\]) other than positive antidsdna and no central nervous system (cns) sle (psychosis, organic brain syndrome, cranial nerve disorder, lupus headache, or new-onset cerebrovascular accident) * history of vaccinations as follows or vaccination against these pathogens during screening: 1. vaccination against streptococcus pneumoniae with pneumococcal polysaccharide vaccine 23 or pneumococcal 13-valent conjugate vaccine as per local guidelines, and 2. vaccination against influenza virus (as per local seasonal recommendations). subjects receiving 1 or more of these vaccinations during screening must have at least 2 weeks between the vaccination(s) and the date of randomization at day 1. * other protocol defined inclusion criteria could apply exclusion criteria: * active clinically significant cns sle * initiation or change in dose of anti-malarial treatment after the screening visit * within 2 weeks prior to screening or during screening: use of oral corticosteroids greater than (\>) 40 mg daily prednisone equivalent, use of any injectable corticosteroids, or change in dose of corticosteroids * within 2 weeks prior to screening, initiation or change in dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, or nonsteroidal anti-inflammatory drugs (nsaids). * within 2 months prior to screening or during screening: initiation of or change in dose of methotrexate, mycophenolate (mofetil or sodium), or azathioprine * within 2 months prior to screening or during screening, use of cyclosporine, tacrolimus, 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 6 months prior to screening or during screening: use of cyclophosphamide or chlorambucil * within 12 months prior to screening or during screening: use of rituximab, belimumab, or any other b cell-depleting or modulating therapies * within 1 month prior to screening or during screening, vaccination with live or live-attenuated virus vaccine. * active clinically significant viral, bacterial or fungal infection, or any serious episode of infection requiring hospitalization within the last 6 months - estimated glomerular filtration rate by the modification of diet in renal disease equation of less than (\ = 3 gram per day (g/day) (spot urine protein/creatinine ratio \>= 3 mg/mg) * other protocol defined exclusion criteria could apply

Keywords: msc2364447c phase 1 btk inhibitor systemic lupus erythematosus m2951 lupus