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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02843659
Other study ID # IM128-035
Secondary ID 2016-000101-37
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 18, 2016
Est. completion date July 24, 2017

Study information

Verified date October 2018
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 45
Est. completion date July 24, 2017
Est. primary completion date July 24, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-931699
Specified dose on specified days
BMS-986142
Specified dose on specified days
Placebo
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution Camperdown New South Wales
Chile Local Institution Santiago De Chile Metropolitana
Colombia Local Institution Bogota Cundinamarca
Colombia Local Institution Bogota
Colombia Local Institution Cali
Italy Azienda Ospedaliera Universitaria Pisana Pisa
Mexico Local Institution Guadalajara Jalisco
Mexico Local Institution Merida Yucatan
Mexico Local Institution Mexico City Distrito Fededral
Mexico Local Institution Veracruz
Peru Local Institution Cercado De Lima Lima
Peru Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac Lima
Peru Local Institution Lima
Poland Klinika Reumatologii i Chorob Wewnetrznych Wroclaw
Puerto Rico Local Institution San Juan
Russian Federation Local Institution Moscow
South Africa Local Institution Stellenbosch Western CAPE
United States New Mexico Clinical Research & Osteoporosis Center Albuquerque New Mexico
United States Tekton Research Inc Austin Texas
United States Altoona Center For Clinical Research Duncansville Pennsylvania
United States Arthritis And Osteoporosis Associates, Pa Freehold New Jersey
United States St Joseph Heritage Healthcare Fullerton California
United States West Tennessee Research Institute Jackson Tennessee
United States North Georgia Rheumatology Group Lawrenceville Georgia
United States Paramount Medical Research & Consulting, Llc Middleburg Heights Ohio
United States Local Institution Mineola New York
United States Acme Research, Llc Orangeburg South Carolina
United States Local Institution Palo Alto California
United States Local Institution Philadelphia Pennsylvania
United States Local Institution Sarasota Florida
United States Local Institution Tupelo Mississippi
United States Local Institution Wexford Pennsylvania
United States Pmg Research Of Wilmington Llc Wilmington North Carolina
United States Clinical Pharmacology Study Group Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Chile,  Colombia,  Italy,  Mexico,  Peru,  Poland,  Puerto Rico,  Russian Federation,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in ESSDAI The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening At baseline and week 12
Secondary Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8 The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening At baseline, week 4 and week 8
Secondary Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12. ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains. At baseline, week 4, week 8, and week 12
Secondary Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12 The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening At week 12
Secondary Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12 The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening At week 12
Secondary Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains At week 12
Secondary Mean Change in Baseline in ESSPRI Individual Component of Dryness ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains At baseline, week 4, week 8, and week 12
Secondary Mean Change in Baseline in ESSPRI Individual Component of Fatigue ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains At baseline, week 4, week 8, and week 12
Secondary Mean Change in Baseline in ESSPRI Individual Component of Pain ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains At baseline, week 4, week 8, and week 12
Secondary Mean Change From Baseline in Unstimulated Salivary Flow Rate Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling. At baseline, week 4, week 8, and week 12
Secondary Mean Change From Baseline in Stimulated Salivary Flow Rate Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling. At baseline, week 4, week 8, and week 12
Secondary Mean Change From Baseline in Ocular Surface Staining The test was performed by instillation of fluorescein dye and either lissamine green or Rose bengal dye to stain the cornea and conjunctiva, respectively. After instilling the dye, the ocular surface was examined through a slit lamp (biomicroscope). At baseline, week 4, week 8, and week 12
Secondary Mean Change From Baseline in Schrimer's Test The test (without anaesthesia) was performed by placing a narrow calibrated filter-paper strip in the inferior cul-de-sac of each eye. Aqueous tear production was measured by the length in millimeters that the strip wets during the 5 minute test period At baseline, week 4, week 8, and week 12
Secondary Mean Change From Baseline in the Tear Break-up Time Test Determined by instilling fluorescein dye and evaluating the stability of the pre-corneal tear film. After several blinks, the tear film is examined using a broad beam of the slit-lamp (biomicroscope) with a cobalt blue filter. The TBUT, defined as the time in seconds between the subjects's last blink and the first appearance of a random dry spot on the corneal surface, is measured 3 times and the mean value is recorded. At baseline, week 4, week 8, and week 12
Secondary Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain(nagging, annoying, interfering little with ADLs), 4-6 = Moderate Pain (interferes significantly with ADLs), 7-10 = Severe Pain (disabling; unable to perform ADLs) At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Secondary Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA) The subjects overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Secondary Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA) The investigator's or physician's overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease. At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
Secondary Mean Change From Baseline in Short Form-36 (SF-36) First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank(missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered At baseline, week 4, week 8, week 12, and week 18
Secondary Mean Change From Baseline in Female Sexual Function Index (FSFI) The Female Sexual Function Index (FSFI), a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women At baseline, week 4, week 8, week 12, and week 18
Secondary Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI) Affords calculation of 4 scales to measure the impact of IBD on different domains of impairment in work or other activities: absenteeism, presenteeism (impairment at work), productivity loss (overall work impairment), activity impairment At baseline, week 4, week 8, week 12, and week 18
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