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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2016-000101-37
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Secondary ID [2]
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IM128-035
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sjögren's Syndrome
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Condition category
Condition code
Inflammatory and Immune System
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Rheumatoid arthritis
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Musculoskeletal
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0
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0
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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0
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Autoimmune diseases
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Change From Baseline in ESSDAI
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Assessment method [1]
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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
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Timepoint [1]
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At baseline and week 12
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Secondary outcome [1]
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Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8
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Assessment method [1]
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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
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Timepoint [1]
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At baseline, week 4 and week 8
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Secondary outcome [2]
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Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.
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Assessment method [2]
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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.
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Timepoint [2]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [3]
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Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12
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Assessment method [3]
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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
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Timepoint [3]
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At week 12
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Secondary outcome [4]
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Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12
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Assessment method [4]
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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
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Timepoint [4]
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At week 12
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Secondary outcome [5]
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Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI
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Assessment method [5]
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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
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Timepoint [5]
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At week 12
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Secondary outcome [6]
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Mean Change in Baseline in ESSPRI Individual Component of Dryness
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Assessment method [6]
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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
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Timepoint [6]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [7]
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Mean Change in Baseline in ESSPRI Individual Component of Fatigue
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Assessment method [7]
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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
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Timepoint [7]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [8]
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Mean Change in Baseline in ESSPRI Individual Component of Pain
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Assessment method [8]
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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
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Timepoint [8]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [9]
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Mean Change From Baseline in Unstimulated Salivary Flow Rate
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Assessment method [9]
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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.
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Timepoint [9]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [10]
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Mean Change From Baseline in Stimulated Salivary Flow Rate
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Assessment method [10]
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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.
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Timepoint [10]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [11]
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Mean Change From Baseline in Ocular Surface Staining
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Assessment method [11]
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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).
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Timepoint [11]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [12]
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Mean Change From Baseline in Schrimer's Test
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Assessment method [12]
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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
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Timepoint [12]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [13]
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Mean Change From Baseline in the Tear Break-up Time Test
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Assessment method [13]
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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.
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Timepoint [13]
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At baseline, week 4, week 8, and week 12
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Secondary outcome [14]
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Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness
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Assessment method [14]
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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)
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Timepoint [14]
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At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18
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Secondary outcome [15]
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Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA)
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Assessment method [15]
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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
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Timepoint [15]
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At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
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Secondary outcome [16]
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Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA)
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Assessment method [16]
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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.
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Timepoint [16]
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At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
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Secondary outcome [17]
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Mean Change From Baseline in Short Form-36 (SF-36)
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Assessment method [17]
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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
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Timepoint [17]
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At baseline, week 4, week 8, week 12, and week 18
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Secondary outcome [18]
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Mean Change From Baseline in Female Sexual Function Index (FSFI)
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Assessment method [18]
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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
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Timepoint [18]
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At baseline, week 4, week 8, week 12, and week 18
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Secondary outcome [19]
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Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI)
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Assessment method [19]
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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
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Timepoint [19]
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At baseline, week 4, week 8, week 12, and week 18
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/07/2017
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Local Institution - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
0
0
United States of America
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State/province [2]
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Florida
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Country [3]
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0
United States of America
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State/province [3]
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Georgia
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Country [4]
0
0
United States of America
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State/province [4]
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0
Massachusetts
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Mississippi
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Country [6]
0
0
United States of America
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State/province [6]
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New Jersey
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Country [7]
0
0
United States of America
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State/province [7]
0
0
New Mexico
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Country [8]
0
0
United States of America
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State/province [8]
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0
New York
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Country [9]
0
0
United States of America
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State/province [9]
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0
North Carolina
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Country [10]
0
0
United States of America
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State/province [10]
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0
Ohio
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Pennsylvania
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Country [12]
0
0
United States of America
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State/province [12]
0
0
South Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Tennessee
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Country [14]
0
0
United States of America
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State/province [14]
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Texas
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Country [15]
0
0
Chile
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State/province [15]
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0
Metropolitana
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Country [16]
0
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Colombia
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State/province [16]
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Cundinamarca
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Country [17]
0
0
Colombia
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State/province [17]
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0
Bogota
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Country [18]
0
0
Colombia
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State/province [18]
0
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Cali
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Country [19]
0
0
Italy
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State/province [19]
0
0
Pisa
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Country [20]
0
0
Mexico
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State/province [20]
0
0
Distrito Fededral
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Country [21]
0
0
Mexico
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State/province [21]
0
0
Jalisco
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Country [22]
0
0
Mexico
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0
0
Yucatan
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Country [23]
0
0
Mexico
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State/province [23]
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Veracruz
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Country [24]
0
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Peru
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State/province [24]
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Lima
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Country [25]
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Poland
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State/province [25]
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Wroclaw
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Country [26]
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Puerto Rico
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State/province [26]
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San Juan
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Country [27]
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Russian Federation
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State/province [27]
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Moscow
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Country [28]
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South Africa
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State/province [28]
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0
Western CAPE
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02843659
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02843659
Download to PDF