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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Sjögren's Syndrome

Treatments: Drug: BMS-986142; Drug: BMS-931699; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02843659

IM128-035

2016-000101-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

BMS-931699

Experimental group

Description:

Subcutaneous weekly injection + daily oral placebo tablets

Treatment:

Drug: BMS-931699

Drug: Placebo

BMS-986142

Experimental group

Description:

Daily oral tablets + subcutaneous placebo (weekly) injection

Treatment:

Drug: BMS-986142

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Weekly subcutaneous placebo injection +daily oral placebo tablets

Treatment:

Drug: Placebo