A Phase 2 interventional study of BMS-931699 and BMS-986142 in Sjögren's Syndrome, sponsored by Bristol-Myers Squibb. Terminated at 34 sites in 11 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-04.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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.
371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Subcutaneous weekly injection + daily oral placebo tablets
Drug: BMS-931699 · Drug: Placebo
Daily oral tablets + subcutaneous placebo (weekly) injection
Drug: BMS-986142 · Drug: Placebo
Weekly subcutaneous placebo injection +daily oral placebo tablets
Drug: Placebo
Specified dose on specified days
Also known as: lulizumab
Specified dose on specified days
Specified dose on specified days
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
Time frame: At baseline and week 12
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
Time frame: At baseline, week 4 and week 8
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.
Time frame: At baseline, week 4, week 8, and week 12
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
Time frame: At week 12
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
Time frame: At week 12
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
Time frame: At week 12
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
Time frame: At baseline, week 4, week 8, and week 12
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
Time frame: At baseline, week 4, week 8, and week 12
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
Time frame: At baseline, week 4, week 8, and week 12
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.
Time frame: At baseline, week 4, week 8, and week 12
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.
Time frame: At baseline, week 4, week 8, and week 12
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).
Time frame: At baseline, week 4, week 8, and week 12
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
Time frame: At baseline, week 4, week 8, and week 12
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.
Time frame: At baseline, week 4, week 8, and week 12
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)
Time frame: At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18
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
Time frame: At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
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.
Time frame: At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
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
Time frame: At baseline, week 4, week 8, week 12, and week 18
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
Time frame: At baseline, week 4, week 8, week 12, and week 18
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
Time frame: At baseline, week 4, week 8, week 12, and week 18
| Milestone | BMS-931699/Lulizumab Injection | BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval) | Placebo |
|---|---|---|---|
| Started | 5 | 6 | 7 |
| Completed | 1 | 0 | 2 |
| Not completed | 4 | 6 | 5 |
| Withdrew: Subject withdrew consent | 0 | 0 | 1 |
| Withdrew: Administrative reason by sponsor | 4 | 5 | 4 |
| Withdrew: Adverse event | 0 | 1 | 0 |
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Collected over Up to 18 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Lulizumab (BMS-931699) 12.5mg QW | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| BMS-986142 350 mg QD | 0/6 (0%) | 1/6 (16.7%) | 4/6 (66.7%) |
| Event | Placebo | Lulizumab (BMS-931699) 12.5mg QW | BMS-986142 350 mg QD |
|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 0/7 | 0/5 | 1/6 |
| Event | Placebo | Lulizumab (BMS-931699) 12.5mg QW | BMS-986142 350 mg QD |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 0/7 | 1/5 | 1/6 |
| Urinary tract infectionInfections and infestations | 1/7 | 1/5 | 0/6 |
| GastroenteritisInfections and infestations | 0/7 | 1/5 | 0/6 |
| Gastroenteritis viralInfections and infestations | 0/7 | 1/5 | 0/6 |
| Soft tissue infectionInfections and infestations | 0/7 | 1/5 | 0/6 |
| Injection site reactionGeneral disorders | 0/7 | 1/5 | 0/6 |
| PainGeneral disorders | 0/7 | 1/5 | 0/6 |
| Blood pressure increasedInvestigations | 0/7 | 1/5 | 0/6 |
| GastritisGastrointestinal disorders | 0/7 | 1/5 | 0/6 |
| Gastrointestinal inflammationGastrointestinal disorders | 0/7 | 1/5 | 0/6 |
| Age, Continuous(Years) | BMS-931699/Lulizumab Injection | BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval) | Placebo | Total |
|---|---|---|---|---|
| Mean | 49.2 ± 11.34 | 51.2 ± 8.77 | 52.6 ± 13.30 | 51.2 ± 11.41 |
| Sex: Female, Male(Participants) | BMS-931699/Lulizumab Injection | BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval) | Placebo | Total |
|---|---|---|---|---|
| Female | 5 | 6 | 7 | 18 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | BMS-931699/Lulizumab Injection | BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval) | Placebo | Total |
|---|---|---|---|---|
| White | 4 | 4 | 7 | 15 |
| Black or African American | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Other | 1 | 2 | 0 | 3 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb