Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2015-11-30
2016-10-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MSC2364447C 25 mg
MSC2364447C
Subjects will be administered with MSC2364447C 25 milligrams orally once daily for 4 weeks.
MSC2364447C 75 mg
MSC2364447C
Subjects will be administered with MSC2364447C 75 milligrams orally once daily for 4 weeks.
Placebo
Placebo
Subjects will be administered with placebo matching to MSC2364447C orally once daily for 4 weeks.
Interventions
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MSC2364447C
Subjects will be administered with MSC2364447C 25 milligrams orally once daily for 4 weeks.
MSC2364447C
Subjects will be administered with MSC2364447C 75 milligrams orally once daily for 4 weeks.
Placebo
Subjects will be administered with placebo matching to MSC2364447C orally once daily for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany
Locations
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Research site
Anniston, Alabama, United States
Research site
El Cajon, California, United States
Research site
Lakewood, California, United States
Research site
Los Angeles, California, United States
Research site
Clearwater, Florida, United States
Research site
DeBary, Florida, United States
Research site
Orlando, Florida, United States
Research site
Grand Blanc, Michigan, United States
Research site
St Louis, Missouri, United States
Research site
Austin, Texas, United States
Research site
Sofia, , Bulgaria
Research site
Sofia, , Bulgaria
Research site
Sofia, , Bulgaria
Countries
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Other Identifiers
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2015-001891-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMR200527-002
Identifier Type: -
Identifier Source: org_study_id