Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02843659
• Collaborator: (none)
• Enrollment: 45
• Locations: 34
• Arms: 3
• Actual Duration (Months): 9.2
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sjögren's Syndrome	Drug: BMS-931699; Drug: BMS-986142; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 18, 2016
• Actual Primary Completion Date: Jul 24, 2017
• Actual Study Completion Date: Jul 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-931699 Subcutaneous weekly injection + daily oral placebo tablets	Drug: BMS-931699; Specified dose on specified days; Other Names: lulizumab ; Drug: Placebo; Specified dose on specified days
Experimental: BMS-986142 Daily oral tablets + subcutaneous placebo (weekly) injection	Drug: BMS-986142; Specified dose on specified days; Drug: Placebo; Specified dose on specified days
Placebo Comparator: Placebo Weekly subcutaneous placebo injection +daily oral placebo tablets	Drug: Placebo; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in ESSDAI [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

Secondary Outcome Measures

1. Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8 [At baseline, 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

2. Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12. [At baseline, 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.

3. Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12 [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

4. Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12 [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

5. Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI [At 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

6. Mean Change in Baseline in ESSPRI Individual Component of Dryness [At baseline, 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

7. Mean Change in Baseline in ESSPRI Individual Component of Fatigue [At baseline, 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

8. Mean Change in Baseline in ESSPRI Individual Component of Pain [At baseline, 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

9. Mean Change From Baseline in Unstimulated Salivary Flow Rate [At baseline, week 4, week 8, and week 12]

   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.

10. Mean Change From Baseline in Stimulated Salivary Flow Rate [At baseline, week 4, week 8, and week 12]

    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.

11. Mean Change From Baseline in Ocular Surface Staining [At baseline, week 4, week 8, and week 12]

    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).

12. Mean Change From Baseline in Schrimer's Test [At baseline, week 4, week 8, and week 12]

    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

13. Mean Change From Baseline in the Tear Break-up Time Test [At baseline, week 4, week 8, and week 12]

    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.

14. Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness [At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18]

    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)

15. Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA) [At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18]

    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

16. Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA) [At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18]

    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.

17. Mean Change From Baseline in Short Form-36 (SF-36) [At baseline, week 4, week 8, week 12, and week 18]

    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

18. Mean Change From Baseline in Female Sexual Function Index (FSFI) [At baseline, week 4, week 8, week 12, and week 18]

    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

19. Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI) [At baseline, week 4, week 8, week 12, and week 18]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Joseph Heritage Healthcare	Fullerton	California	United States	92835
2	Local Institution	Palo Alto	California	United States	94304
3	Local Institution	Sarasota	Florida	United States	34239
4	North Georgia Rheumatology Group	Lawrenceville	Georgia	United States	30096
5	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01605
6	Local Institution	Tupelo	Mississippi	United States	38801
7	Arthritis And Osteoporosis Associates, Pa	Freehold	New Jersey	United States	07728
8	New Mexico Clinical Research & Osteoporosis Center	Albuquerque	New Mexico	United States	87109
9	Local Institution	Mineola	New York	United States	11501
10	Pmg Research Of Wilmington Llc	Wilmington	North Carolina	United States	28401
11	Paramount Medical Research & Consulting, Llc	Middleburg Heights	Ohio	United States	44130
12	Altoona Center For Clinical Research	Duncansville	Pennsylvania	United States	16635-8406
13	Local Institution	Philadelphia	Pennsylvania	United States	19104
14	Local Institution	Wexford	Pennsylvania	United States	15090
15	Acme Research, Llc	Orangeburg	South Carolina	United States	29118
16	West Tennessee Research Institute	Jackson	Tennessee	United States	38305
17	Tekton Research Inc	Austin	Texas	United States	78745
18	Local Institution	Camperdown	New South Wales	Australia	2050
19	Local Institution	Santiago De Chile	Metropolitana	Chile	7501126
20	Local Institution	Bogota	Cundinamarca	Colombia
21	Local Institution	Bogota		Colombia
22	Local Institution	Cali		Colombia
23	Azienda Ospedaliera Universitaria Pisana	Pisa		Italy	56126
24	Local Institution	Mexico City	Distrito Fededral	Mexico	11850
25	Local Institution	Guadalajara	Jalisco	Mexico	44650
26	Local Institution	Merida	Yucatan	Mexico	97070
27	Local Institution	Veracruz		Mexico	91910
28	Local Institution	Cercado De Lima	Lima	Peru	1
29	Local Institution	Lima		Peru	LIMA 31
30	Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac	Lima		Peru	LIMA 33
31	Klinika Reumatologii i Chorob Wewnetrznych	Wroclaw		Poland	50-556
32	Local Institution	San Juan		Puerto Rico	00909
33	Local Institution	Moscow		Russian Federation	121374
34	Local Institution	Stellenbosch	Western CAPE	South Africa	7600

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

• Study Protocol - Feb 13, 2017
• Statistical Analysis Plan - May 15, 2017

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02843659
• Other Study ID Numbers: IM128-035; 2016-000101-37
• First Posted: Jul 26, 2016
• Last Update Posted: Oct 4, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sjogren's Syndrome; Syndrome

Study Results

Participant Flow

Pre-assignment Detail	45 subjects enrolled, 18 subjects were randomized/treated. 15 subjects didn't complete the treatment period. The study was terminated and the remaining 15 randomized subjects who had not yet completed the double-blind period entered the follow-up period. Of the 15 subjects who entered the follow-up period, 12 did not complete the follow-up period

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Period Title: Overall Study
STARTED	5	6	7
COMPLETED	1	0	2
NOT COMPLETED	4	6	5

Baseline Characteristics

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo	Total
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet	Total of all reporting groups
Overall Participants	5	6	7	18
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.2 (11.34)	51.2 (8.77)	52.6 (13.30)	51.2 (11.41)
Sex: Female, Male (Count of Participants)
Female	5 100%	6 100%	7 100%	18 100%
Male	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
White	4 80%	4 66.7%	7 100%	15 83.3%
Black or African American	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Other	1 20%	2 33.3%	0 0%	3 16.7%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in ESSDAI
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

2. Secondary Outcome

Title	Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

3. Secondary Outcome

Title	Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

4. Secondary Outcome

Title	Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

5. Secondary Outcome

Title	Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

6. Secondary Outcome

Title	Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

7. Secondary Outcome

Title	Mean Change in Baseline in ESSPRI Individual Component of Dryness
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

8. Secondary Outcome

Title	Mean Change in Baseline in ESSPRI Individual Component of Fatigue
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

9. Secondary Outcome

Title	Mean Change in Baseline in ESSPRI Individual Component of Pain
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

10. Secondary Outcome

Title	Mean Change From Baseline in Unstimulated Salivary Flow Rate
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

11. Secondary Outcome

Title	Mean Change From Baseline in Stimulated Salivary Flow Rate
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

12. Secondary Outcome

Title	Mean Change From Baseline in Ocular Surface Staining
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

13. Secondary Outcome

Title	Mean Change From Baseline in Schrimer's Test
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

14. Secondary Outcome

Title	Mean Change From Baseline in the Tear Break-up Time Test
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

15. Secondary Outcome

Title	Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

16. Secondary Outcome

Title	Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA)
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

17. Secondary Outcome

Title	Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA)
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

18. Secondary Outcome

Title	Mean Change From Baseline in Short Form-36 (SF-36)
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

19. Secondary Outcome

Title	Mean Change From Baseline in Female Sexual Function Index (FSFI)
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

20. Secondary Outcome

Title	Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI)
Description	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

Outcome Measure Data

Analysis Population Description

The study was terminated and data is not reported for privacy reasons

Arm/Group Title	BMS-931699/Lulizumab Injection	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	Placebo
Arm/Group Description	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)	For oral administration, 350 mg	For BMS-986142 50 mg tablet (round) or 150 mg tablet
Measure Participants	0	0	0

Adverse Events

Time Frame	Up to 18 weeks
Arm/Group Title	Placebo		Lulizumab (BMS-931699) 12.5mg QW		BMS-986142 350 mg QD
Arm/Group Description	Subjects received subcutaneous (SC) injection of placebo matched to 12.5 milligram (mg) lulizumab (BMS-931699) weekly (QW) and oral tablets of placebo matched to 350 mg BMS-986142 once daily (QD) for 12 weeks.		Subjects received SC injection of 12.5 mg lulizumab (BMS-931699) QW and oral tablets of placebo matched to 350 mg BMS-986142 QD for 12 weeks.		Subjects received oral tablets of 350 mg BMS-986142 QD and placebo matched to SC injection of 12.5 mg lulizumab (BMS-931699) QW for 12 weeks.
All Cause Mortality
	Placebo		Lulizumab (BMS-931699) 12.5mg QW		BMS-986142 350 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/5 (0%)		0/6 (0%)
Serious Adverse Events
	Placebo		Lulizumab (BMS-931699) 12.5mg QW		BMS-986142 350 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/5 (0%)		1/6 (16.7%)
Blood and lymphatic system disorders
Thrombocytopenia	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Lulizumab (BMS-931699) 12.5mg QW		BMS-986142 350 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/7 (28.6%)		4/5 (80%)		4/6 (66.7%)
Blood and lymphatic system disorders
Iron deficiency anaemia	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Gastrointestinal disorders
Gastritis	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Gastrointestinal inflammation	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
General disorders
Fatigue	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Injection site haematoma	1/7 (14.3%)	1	0/5 (0%)	0	0/6 (0%)	0
Injection site reaction	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Pain	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Sensation of foreign body	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Anticoagulation drug level above therapeutic	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Infections and infestations
Upper respiratory tract infection	0/7 (0%)	0	1/5 (20%)	1	1/6 (16.7%)	1
Urinary tract infection	1/7 (14.3%)	1	1/5 (20%)	1	0/6 (0%)	1
Bronchitis	1/7 (14.3%)	1	0/5 (0%)	0	0/6 (0%)	0
Gastroenteritis	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Gastroenteritis viral	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Influenza	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Soft tissue infection	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Injury, poisoning and procedural complications
Stress fracture	1/7 (14.3%)	1	0/5 (0%)	0	0/6 (0%)	0
Investigations
Alanine aminotransferase increased	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	2
Aspartate aminotransferase increased	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Blood pressure increased	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Metabolism and nutrition disorders
Hypertriglyceridaemia	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Hypokalaemia	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Vitamin B12 deficiency	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Musculoskeletal and connective tissue disorders
Back pain	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Muscle spasms	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Nervous system disorders
Headache	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Psychiatric disorders
Depression	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Rhinitis allergic	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0
Skin and subcutaneous tissue disorders
Urticaria	0/7 (0%)	0	0/5 (0%)	0	1/6 (16.7%)	1
Vascular disorders
Hypertension	0/7 (0%)	0	1/5 (20%)	1	0/6 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.