MSC2364447C Phase 1b in Systemic Lupus Erythematosus | NCT02537028

ID	Type	Description	Link
2015-001891-23	EudraCT Number

Status Module

Name	Class
Merck KGaA, Darmstadt, Germany	INDUSTRY

Label	Type	Intervention Names
MSC2364447C 25 mg	Experimental	Drug: MSC2364447C
MSC2364447C 75 mg	Experimental	Drug: MSC2364447C
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MSC2364447C	Drug	Subjects will be administered with MSC2364447C 25 milligrams orally once daily for 4 weeks.	MSC2364447C 25 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with treatment emergent adverse events (TEAEs)	TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration up to 4 weeks after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.	From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration
Number of subjects with TEAEs according to severity	The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v 4.03) definitions of Grade 1 through Grade 5 following his/her best medical judgment. The severity of the AEs will be classified as follows: Grade 1 or mild, Grade 2 or moderate, Grade 3 or severe, Grade 4 or life-threatening and Grade 5 or death.	From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration
Number of subjects with clinically significant laboratory abnormalities	Clinical laboratory parameters being monitored for safety will be summarized using descriptive statistics, by postdose shifts relative to Baseline for relevant parameters using relevant cut-offs. Clinical significance will be determined by investigator.	screening up to Day 56
Number of subjects with clinically significant abnormal vital signs: blood pressure, pulse rate, respiratory rate	Observed values and changes from Baseline in vital signs will be summarized for each treatment group using descriptive statistics. Clinically noteworthy changes in vital signs will be listed and summarized as appropriate. A semi-automated blood pressure and pulse rate recording device with an appropriate cuff size will be utilized. Blood pressure and pulse rate will be measured after 10 minutes' rest in the semi-supine position with the subject's arm unconstrained by clothing or other material. The blood pressure should be assessed on the same arm for each subject throughout the trial. Clinical significance will be determined by investigator.

Secondary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration-time curve from time zero to 6 hours after administration (AUC0-6)		Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28
Maximum observed plasma concentration (Cmax)		Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28

Eligibility Module

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 (<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2), or recent decline in kidney function, or proteinuria >= 3 gram per day (g/day) (spot urine protein/creatinine ratio >= 3 mg/mg)
Other protocol defined exclusion criteria could apply

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Anniston	Alabama	36207	United States
Research site

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases