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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02843659




Registration number
NCT02843659
Ethics application status
Date submitted
8/07/2016
Date registered
26/07/2016
Date last updated
4/10/2018

Titles & IDs
Public title
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
Scientific 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
Secondary ID [1] 0 0
2016-000101-37
Secondary ID [2] 0 0
IM128-035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjögren's Syndrome 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-931699
Treatment: Drugs - BMS-986142
Treatment: Drugs - Placebo

Experimental: BMS-931699 - Subcutaneous weekly injection + daily oral placebo tablets

Experimental: BMS-986142 - Daily oral tablets + subcutaneous placebo (weekly) injection

Placebo comparator: Placebo - Weekly subcutaneous placebo injection +daily oral placebo tablets


Treatment: Drugs: BMS-931699
Specified dose on specified days

Treatment: Drugs: BMS-986142
Specified dose on specified days

Treatment: Drugs: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in ESSDAI
Timepoint [1] 0 0
At baseline and week 12
Secondary outcome [1] 0 0
Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8
Timepoint [1] 0 0
At baseline, week 4 and week 8
Secondary outcome [2] 0 0
Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.
Timepoint [2] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [3] 0 0
Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12
Timepoint [3] 0 0
At week 12
Secondary outcome [4] 0 0
Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12
Timepoint [4] 0 0
At week 12
Secondary outcome [5] 0 0
Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI
Timepoint [5] 0 0
At week 12
Secondary outcome [6] 0 0
Mean Change in Baseline in ESSPRI Individual Component of Dryness
Timepoint [6] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [7] 0 0
Mean Change in Baseline in ESSPRI Individual Component of Fatigue
Timepoint [7] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [8] 0 0
Mean Change in Baseline in ESSPRI Individual Component of Pain
Timepoint [8] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [9] 0 0
Mean Change From Baseline in Unstimulated Salivary Flow Rate
Timepoint [9] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [10] 0 0
Mean Change From Baseline in Stimulated Salivary Flow Rate
Timepoint [10] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [11] 0 0
Mean Change From Baseline in Ocular Surface Staining
Timepoint [11] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [12] 0 0
Mean Change From Baseline in Schrimer's Test
Timepoint [12] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [13] 0 0
Mean Change From Baseline in the Tear Break-up Time Test
Timepoint [13] 0 0
At baseline, week 4, week 8, and week 12
Secondary outcome [14] 0 0
Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness
Timepoint [14] 0 0
At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Secondary outcome [15] 0 0
Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA)
Timepoint [15] 0 0
At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Secondary outcome [16] 0 0
Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA)
Timepoint [16] 0 0
At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Secondary outcome [17] 0 0
Mean Change From Baseline in Short Form-36 (SF-36)
Timepoint [17] 0 0
At baseline, week 4, week 8, week 12, and week 18
Secondary outcome [18] 0 0
Mean Change From Baseline in Female Sexual Function Index (FSFI)
Timepoint [18] 0 0
At baseline, week 4, week 8, week 12, and week 18
Secondary outcome [19] 0 0
Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI)
Timepoint [19] 0 0
At baseline, week 4, week 8, week 12, and week 18

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



* 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/07/2017
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Chile
State/province [15] 0 0
Metropolitana
Country [16] 0 0
Colombia
State/province [16] 0 0
Cundinamarca
Country [17] 0 0
Colombia
State/province [17] 0 0
Bogota
Country [18] 0 0
Colombia
State/province [18] 0 0
Cali
Country [19] 0 0
Italy
State/province [19] 0 0
Pisa
Country [20] 0 0
Mexico
State/province [20] 0 0
Distrito Fededral
Country [21] 0 0
Mexico
State/province [21] 0 0
Jalisco
Country [22] 0 0
Mexico
State/province [22] 0 0
Yucatan
Country [23] 0 0
Mexico
State/province [23] 0 0
Veracruz
Country [24] 0 0
Peru
State/province [24] 0 0
Lima
Country [25] 0 0
Poland
State/province [25] 0 0
Wroclaw
Country [26] 0 0
Puerto Rico
State/province [26] 0 0
San Juan
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
South Africa
State/province [28] 0 0
Western CAPE

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02843659
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02843659