Clinical trial NCT02843659: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
Official title: A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Subjects With Moderate to Severe Primary Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sjögren's Syndrome
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline in ESSDAI
timeFrame: At baseline and week 12
Secondary outcomes:
measure: Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8
timeFrame: At baseline, week 4 and week 8
measure: Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.
timeFrame: At baseline, week 4, week 8, and week 12
measure: Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12
timeFrame: At week 12
measure: Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12
timeFrame: At week 12
measure: Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI
timeFrame: At week 12
measure: Mean Change in Baseline in ESSPRI Individual Component of Dryness
timeFrame: At baseline, week 4, week 8, and week 12
measure: Mean Change in Baseline in ESSPRI Individual Component of Fatigue
timeFrame: At baseline, week 4, week 8, and week 12
measure: Mean Change in Baseline in ESSPRI Individual Component of Pain
timeFrame: At baseline, week 4, week 8, and week 12
measure: Mean Change From Baseline in Unstimulated Salivary Flow Rate
timeFrame: At baseline, week 4, week 8, and week 12
measure: Mean Change From Baseline in Stimulated Salivary Flow Rate
timeFrame: At baseline, week 4, week 8, and week 12
measure: Mean Change From Baseline in Ocular Surface Staining
timeFrame: At baseline, week 4, week 8, and week 12
measure: Mean Change From Baseline in Schrimer's Test
timeFrame: At baseline, week 4, week 8, and week 12
measure: Mean Change From Baseline in the Tear Break-up Time Test
timeFrame: At baseline, week 4, week 8, and week 12
measure: Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness
timeFrame: At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18
measure: Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA)
timeFrame: At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
measure: Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA)
timeFrame: At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
measure: Mean Change From Baseline in Short Form-36 (SF-36)
timeFrame: At baseline, week 4, week 8, week 12, and week 18
measure: Mean Change From Baseline in Female Sexual Function Index (FSFI)
timeFrame: At baseline, week 4, week 8, week 12, and week 18
measure: Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI)
timeFrame: At baseline, week 4, week 8, week 12, and week 18
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Palo Alto
country: United States
facility: Local Institution
state: California
city: Sarasota
country: United States
facility: Local Institution
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group
state: Georgia
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Tupelo
country: United States
facility: Local Institution
state: Mississippi
city: Freehold
country: United States
facility: Arthritis And Osteoporosis Associates, Pa
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center
state: New Mexico
city: Mineola
country: United States
facility: Local Institution
state: New York
city: Wilmington
country: United States
facility: Pmg Research Of Wilmington Llc
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, Llc
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Wexford
country: United States
facility: Local Institution
state: Pennsylvania
city: Orangeburg
country: United States
facility: Acme Research, Llc
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Austin
country: United States
facility: Tekton Research Inc
state: Texas
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Santiago De Chile
country: Chile
facility: Local Institution
state: Metropolitana
city: Bogota
country: Colombia
facility: Local Institution
state: Cundinamarca
city: Bogota
country: Colombia
facility: Local Institution
city: Cali
country: Colombia
facility: Local Institution
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Fededral
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Veracruz
country: Mexico
facility: Local Institution
city: Cercado De Lima
country: Peru
facility: Local Institution
state: Lima
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
city: Wroclaw
country: Poland
facility: Klinika Reumatologii i Chorob Wewnetrznych
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Stellenbosch
country: South Africa
facility: Local Institution
state: Western CAPE
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: