Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Sjögren's Syndrome

In brief

The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.

Key facts

Study ID

NCT02843659

Run by

Bristol-Myers Squibb

People needed

45

Starts

2016-10-18

Expected to finish

2017-07-24

Last updated by the study team

2018-10-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects diagnosed or classified as having moderate to severe primary Sjögren's Syndrome based on the 2016 ACR-EULAR Sjögren's Syndrome Classification Criteria for at least 16 weeks prior to screening
• 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

You may not qualify if…

• Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis, vasculitis)
• 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
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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