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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago De Chile, Metropolitana, Chile, 7501126
        • Local Institution
  • Colombia
      • Bogota, Colombia
        • Local Institution
      • Cali, Colombia
        • Local Institution
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Local Institution
  • Italy
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Universitaria Pisana
  • Mexico
      • 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
  • Peru
      • 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
  • Poland
      • Wroclaw, Poland, 50-556
        • Klinika Reumatologii i Chorob Wewnetrznych
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 121374
        • Local Institution
  • South Africa
    • Western CAPE
      • Stellenbosch, Western CAPE, South Africa, 7600
        • Local Institution
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BMS-931699
Subcutaneous weekly injection + daily oral placebo tablets
Drug: Placebo
Specified dose on specified days
Drug: BMS-931699
Specified dose on specified days
Other Names:
  • lulizumab
Experimental: BMS-986142
Daily oral tablets + subcutaneous placebo (weekly) injection
Drug: Placebo
Specified dose on specified days
Drug: BMS-986142
Specified dose on specified days
Placebo Comparator: Placebo
Weekly subcutaneous placebo injection +daily oral placebo tablets
Drug: Placebo
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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