- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02843659
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
October 3, 2018 updated by: Bristol-Myers Squibb
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- Local Institution
-
-
-
-
Metropolitana
-
Santiago De Chile, Metropolitana, Chile, 7501126
- Local Institution
-
-
-
-
-
Bogota, Colombia
- Local Institution
-
Cali, Colombia
- Local Institution
-
-
Cundinamarca
-
Bogota, Cundinamarca, Colombia
- Local Institution
-
-
-
-
-
Pisa, Italy, 56126
- Azienda Ospedaliera Universitaria Pisana
-
-
-
-
-
Veracruz, Mexico, 91910
- Local Institution
-
-
Distrito Fededral
-
Mexico City, Distrito Fededral, Mexico, 11850
- Local Institution
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44650
- Local Institution
-
-
Yucatan
-
Merida, Yucatan, Mexico, 97070
- Local Institution
-
-
-
-
-
Lima, Peru, LIMA 33
- Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
-
Lima, Peru, LIMA 31
- Local Institution
-
-
Lima
-
Cercado De Lima, Lima, Peru, 1
- Local Institution
-
-
-
-
-
Wroclaw, Poland, 50-556
- Klinika Reumatologii i Chorob Wewnetrznych
-
-
-
-
-
San Juan, Puerto Rico, 00909
- Local Institution
-
-
-
-
-
Moscow, Russian Federation, 121374
- Local Institution
-
-
-
-
Western CAPE
-
Stellenbosch, Western CAPE, South Africa, 7600
- Local Institution
-
-
-
-
California
-
Fullerton, California, United States, 92835
- St Joseph Heritage Healthcare
-
Palo Alto, California, United States, 94304
- Local Institution
-
-
Florida
-
Sarasota, Florida, United States, 34239
- Local Institution
-
-
Georgia
-
Lawrenceville, Georgia, United States, 30096
- North Georgia Rheumatology Group
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- Clinical Pharmacology Study Group
-
-
Mississippi
-
Tupelo, Mississippi, United States, 38801
- Local Institution
-
-
New Jersey
-
Freehold, New Jersey, United States, 07728
- Arthritis And Osteoporosis Associates, Pa
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87109
- New Mexico Clinical Research & Osteoporosis Center
-
-
New York
-
Mineola, New York, United States, 11501
- Local Institution
-
-
North Carolina
-
Wilmington, North Carolina, United States, 28401
- Pmg Research Of Wilmington Llc
-
-
Ohio
-
Middleburg Heights, Ohio, United States, 44130
- Paramount Medical Research & Consulting, LLC
-
-
Pennsylvania
-
Duncansville, Pennsylvania, United States, 16635-8406
- Altoona Center for Clinical Research
-
Philadelphia, Pennsylvania, United States, 19104
- Local Institution
-
Wexford, Pennsylvania, United States, 15090
- Local Institution
-
-
South Carolina
-
Orangeburg, South Carolina, United States, 29118
- Acme Research, Llc
-
-
Tennessee
-
Jackson, Tennessee, United States, 38305
- West Tennessee Research Institute
-
-
Texas
-
Austin, Texas, United States, 78745
- Tekton Research Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects diagnosed or classified as having moderate to severe primary Sjögren's Syndrome based on the 2016 ACR-EULAR Sjögren's Syndrome Classification Criteria for at least 16 weeks prior to screening
- ESSDAI ≥ 5 including disease activity (any score > 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
- Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody
- Unstimulated whole saliva secretion > 0.01 ml/min
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted
Exclusion Criteria:
- Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis, vasculitis)
- Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit
- Active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection
- Any significant concurrent medical condition at the time of screening or baseline visit
- Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit
- Previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit
- Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit
- Oral corticosteroids > 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit
Other protocol defined inclusion/exclusion criteria could apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BMS-931699
Subcutaneous weekly injection + daily oral placebo tablets
|
Specified dose on specified days
Specified dose on specified days
Other Names:
|
Experimental: BMS-986142
Daily oral tablets + subcutaneous placebo (weekly) injection
|
Specified dose on specified days
Specified dose on specified days
|
Placebo Comparator: Placebo
Weekly subcutaneous placebo injection +daily oral placebo tablets
|
Specified dose on specified days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At baseline and week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8
Time Frame: 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
|
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
|
ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue.
It uses 0-10 numerical scales, one for each domain.
The weight of the domains is identical, and the final score is the mean score of the 3 domains.
|
At baseline, week 4, week 8, and week 12
|
Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12
Time Frame: At week 12
|
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity.
A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity.
For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight.
The sum of the weighted domain scores is the overall score, which can range from 0 to 123.
A higher score indicates more disease activity.
Change from baseline was computed as the value at Week 24 minus the baseline value.
A negative value in change from baseline indicates an improvement and a positive value indicates worsening
|
At week 12
|
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
|
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity.
A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity.
For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight.
The sum of the weighted domain scores is the overall score, which can range from 0 to 123.
A higher score indicates more disease activity.
Change from baseline was computed as the value at Week 24 minus the baseline value.
A negative value in change from baseline indicates an improvement and a positive value indicates worsening
|
At week 12
|
Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI
Time Frame: 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
|
At week 12
|
Mean Change in Baseline in ESSPRI Individual Component of Dryness
Time Frame: 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
|
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
|
ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue.
It uses 0-10 numerical scales, one for each domain.
The weight of the domains is identical, and the final score is the mean score of the 3 domains
|
At baseline, week 4, week 8, and week 12
|
Mean Change in Baseline in ESSPRI Individual Component of Pain
Time Frame: 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
|
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
|
Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes.
These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.
|
At baseline, week 4, week 8, and week 12
|
Mean Change From Baseline in Stimulated Salivary Flow Rate
Time Frame: 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.
|
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
|
The test was performed by instillation of fluorescein dye and either lissamine green or Rose bengal dye to stain the cornea and conjunctiva, respectively.
After instilling the dye, the ocular surface was examined through a slit lamp (biomicroscope).
|
At baseline, week 4, week 8, and week 12
|
Mean Change From Baseline in Schrimer's Test
Time Frame: 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
|
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
|
Determined by instilling fluorescein dye and evaluating the stability of the pre-corneal tear film.
After several blinks, the tear film is examined using a broad beam of the slit-lamp (biomicroscope) with a cobalt blue filter.
The TBUT, defined as the time in seconds between the subjects's last blink and the first appearance of a random dry spot on the corneal surface, is measured 3 times and the mean value is recorded.
|
At baseline, week 4, week 8, and week 12
|
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
|
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain.
0 = No Pain, 1-3 = Mild Pain(nagging, annoying, interfering little with ADLs), 4-6 = Moderate Pain (interferes significantly with ADLs), 7-10 = Severe Pain (disabling; unable to perform ADLs)
|
At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18
|
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
|
The subjects overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease
|
At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
|
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
|
The investigator's or physician's overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease.
|
At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18
|
Mean Change From Baseline in Short Form-36 (SF-36)
Time Frame: 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
|
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
|
The Female Sexual Function Index (FSFI), a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women
|
At baseline, week 4, week 8, week 12, and week 18
|
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
|
Affords calculation of 4 scales to measure the impact of IBD on different domains of impairment in work or other activities: absenteeism, presenteeism (impairment at work), productivity loss (overall work impairment), activity impairment
|
At baseline, week 4, week 8, week 12, and week 18
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2016
Primary Completion (Actual)
July 24, 2017
Study Completion (Actual)
July 24, 2017
Study Registration Dates
First Submitted
July 8, 2016
First Submitted That Met QC Criteria
July 21, 2016
First Posted (Estimate)
July 26, 2016
Study Record Updates
Last Update Posted (Actual)
October 4, 2018
Last Update Submitted That Met QC Criteria
October 3, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Syndrome
- Sjogren's Syndrome
Other Study ID Numbers
- IM128-035
- 2016-000101-37 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sjögren's Syndrome
-
BiogenCompletedHealthy | Sjögren's Syndrome | Sicca SyndromeUnited States
-
argenxIqvia Pty LtdRecruitingPrimary Sjögren's SyndromeBelgium, Hungary, Poland
-
Bristol-Myers SquibbRecruitingSjögren's SyndromeUnited States, Australia, Germany, Austria, China, Korea, Republic of, Puerto Rico, Poland, Japan, Canada, Hungary, Spain, Argentina, Chile, Denmark, France, Italy, Mexico, Peru, Taiwan, Netherlands, Belgium, Brazil, Colombia, United Kingdom and more
-
Assistance Publique - Hôpitaux de ParisRecruitingPrimary Sjögren's Syndrome (pSS)France
-
Peking University People's HospitalRecruitingPrimary Sjögren's SyndromeChina
-
Second Affiliated Hospital, School of Medicine,...RecruitingPrimary Sjögren's SyndromeChina
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
RemeGen Co., Ltd.CompletedA Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's SyndromePrimary Sjögren's SyndromeChina
-
University Medical Center GroningenBristol-Myers SquibbCompletedSjögren's SyndromeNetherlands
-
University Hospital, Strasbourg, FranceCompletedPrimary Sjögren's Syndrome (pSS)France
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States