Sjögren's SyndromePhase 2NCT02843659
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
A Phase 2 study testing BMS-931699 and BMS-986142 in people with Sjögren's Syndrome, run by Bristol-Myers Squibb at 34 sites in 11 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- BMS-931699 and BMS-986142
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 34 sitesin 11 countries
- Study dates
- 18 Oct 2016to 24 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
34 sites in 11 countries.
34 sites in 11 countries
United States17 sites
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87109
Tekton Research Inc
Austin, Texas, 78745
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635-8406
Arthritis And Osteoporosis Associates, Pa
Freehold, New Jersey, 07728
St Joseph Heritage Healthcare
Fullerton, California, 92835
West Tennessee Research Institute
Jackson, Tennessee, 38305
North Georgia Rheumatology Group
Lawrenceville, Georgia, 30096
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, 44130
Local Institution
Mineola, New York, 11501
Acme Research, Llc
Orangeburg, South Carolina, 29118
Local Institution
Palo Alto, California, 94304
Local Institution
Philadelphia, Pennsylvania, 19104
Local Institution
Sarasota, Florida, 34239
Local Institution
Tupelo, Mississippi, 38801
Local Institution
Wexford, Pennsylvania, 15090
Pmg Research Of Wilmington Llc
Wilmington, North Carolina, 28401
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
Mexico4 sites
Local Institution
Guadalajara, Jalisco, 44650
Local Institution
Mérida, Yucatán, 97070
Local Institution
Mexico City, Distrito Fededral, 11850
Local Institution
Veracruz, 91910
Colombia3 sites
Local Institution
Bogota, Cundinamarca
Local Institution
Bogotá
Local Institution
Cali
Peru3 sites
Local Institution
Lima, LIMA 31
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
Lima, LIMA 33
Local Institution
Lima Cercado, Lima region, 1
About this study
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
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.
- Conditions
- Sjögren's Syndrome
- Being tested
- BMS-931699, BMS-986142, Placebo
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-931699Drug
Also called lulizumab
Specified dose on specified days
BMS-986142Drug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-931699 | Experimental | Subcutaneous weekly injection + daily oral placebo tablets Receives: Drug: BMS-931699; Drug: Placebo |
| BMS-986142 | Experimental | Daily oral tablets + subcutaneous placebo (weekly) injection Receives: Drug: BMS-986142; Drug: Placebo |
| Placebo | Placebo comparator | Weekly subcutaneous placebo injection +daily oral placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and week 12
Secondary outcomes (19)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline, week 4, week 8, week 12, and week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start18 Oct 2016
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
Why it stopped: Inability to meet protocol objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843659
- Sponsor's protocol ID
- IM128-035
- Other IDs
- 2016-000101-37, 2016
- Status last verified
- Oct 2018
- First submitted
- 8 Jul 2016
- Last updated
- 4 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02843659
- Acronym / sponsor ID
- IM128-035
- Conditions
- Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to meet protocol objectives
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Posted 4 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMS-931699 | Experimental | Drug: BMS-931699, Drug: PlaceboSubcutaneous weekly injection + daily oral placebo tablets |
| BMS-986142 | Experimental | Drug: BMS-986142, Drug: PlaceboDaily oral tablets + subcutaneous placebo (weekly) injection |
| Placebo | Placebo comparator | Drug: PlaceboWeekly subcutaneous placebo injection +daily oral placebo tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-931699Also: lulizumabSpecified dose on specified days | Drug | BMS-931699 |
| BMS-986142Specified dose on specified days | Drug | BMS-986142 |
| PlaceboSpecified dose on specified days | Drug | BMS-931699, BMS-986142, Placebo |
Primary outcome
Mean Change From Baseline in ESSDAI
Time frame: At baseline and 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
19 secondary outcomes
Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8
Time frame: At baseline, week 4 and week 8
Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.
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
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
Time frame: At week 12
Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI
Time frame: At week 12
Mean Change in Baseline in ESSPRI Individual Component of Dryness
Time frame: At baseline, week 4, week 8, and week 12
Mean Change in Baseline in ESSPRI Individual Component of Fatigue
Time frame: At baseline, week 4, week 8, and week 12
Mean Change in Baseline in ESSPRI Individual Component of Pain
Time frame: At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Unstimulated Salivary Flow Rate
Time frame: At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Stimulated Salivary Flow Rate
Time frame: At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Ocular Surface Staining
Time frame: At baseline, week 4, week 8, and week 12
Mean Change From Baseline in Schrimer's Test
Time frame: At baseline, week 4, week 8, and week 12
Mean Change From Baseline in the Tear Break-up Time Test
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
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)
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)
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)
Time frame: At baseline, week 4, week 8, week 12, and week 18
Mean Change From Baseline in Female Sexual Function Index (FSFI)
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)
Time frame: At baseline, week 4, week 8, week 12, and week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
34 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-931699 and BMS-986142 in people with Sjögren's Syndrome, run by Bristol-Myers Squibb at 34 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Mexico, Colombia, Peru, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in ESSDAI (time frame: At baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.