Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
NCT ID: NCT02843659
Last Updated: 2018-10-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
45 participants
INTERVENTIONAL
2016-10-18
2017-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BMS-931699
Subcutaneous weekly injection + daily oral placebo tablets
BMS-931699
Specified dose on specified days
Placebo
Specified dose on specified days
BMS-986142
Daily oral tablets + subcutaneous placebo (weekly) injection
BMS-986142
Specified dose on specified days
Placebo
Specified dose on specified days
Placebo
Weekly subcutaneous placebo injection +daily oral placebo tablets
Placebo
Specified dose on specified days
Interventions
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BMS-931699
Specified dose on specified days
BMS-986142
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ESSDAI ≥ 5 including disease activity (any score \> 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
* Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody
* Unstimulated whole saliva secretion \> 0.01 ml/min
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted
Exclusion Criteria
* Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit
* Active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection
* Any significant concurrent medical condition at the time of screening or baseline visit
* Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit
* Previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit
* Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit
* Oral corticosteroids \> 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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St Joseph Heritage Healthcare
Fullerton, California, United States
Local Institution
Palo Alto, California, United States
Local Institution
Sarasota, Florida, United States
North Georgia Rheumatology Group
Lawrenceville, Georgia, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Local Institution
Tupelo, Mississippi, United States
Arthritis And Osteoporosis Associates, Pa
Freehold, New Jersey, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, United States
Local Institution
Mineola, New York, United States
Pmg Research Of Wilmington Llc
Wilmington, North Carolina, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Wexford, Pennsylvania, United States
Acme Research, Llc
Orangeburg, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Tekton Research Inc
Austin, Texas, United States
Local Institution
Camperdown, New South Wales, Australia
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Bogota, Cundinamarca, Colombia
Local Institution
Bogotá, , Colombia
Local Institution
Cali, , Colombia
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Local Institution
Mexico City, Distrito Fededral, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Veracruz, , Mexico
Local Institution
Lima Cercado, Lima region, Peru
Local Institution
Lima, , Peru
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
Lima, , Peru
Klinika Reumatologii i Chorob Wewnetrznych
Wroclaw, , Poland
Local Institution
San Juan, , Puerto Rico
Local Institution
Moscow, , Russia
Local Institution
Stellenbosch, Western Cape, South Africa
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2016-000101-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM128-035
Identifier Type: -
Identifier Source: org_study_id
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