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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02843659
• Date of registration: 08/07/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
• Scientific 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
• Date of first enrolment: October 18, 2016
• Target sample size: 45
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02843659
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Chile, Colombia, France, Hungary, Italy, Mexico, Peru, Poland, Puerto Rico, Russian Federation, South Africa, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sjögren's Syndrome

Intervention(s)

Drug: BMS-931699

Drug: BMS-986142

Drug: Placebo

Primary Outcome(s)

Mean Change From Baseline in ESSDAI [Time Frame: At baseline and week 12]

Secondary Outcome(s)

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

Mean Change in Baseline in ESSPRI Individual Component of Dryness [Time Frame: At baseline, week 4, week 8, and week 12]

Mean Change in Baseline in ESSPRI Individual Component of Fatigue [Time Frame: At baseline, week 4, week 8, and week 12]

Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12. [Time Frame: At baseline, week 4, week 8, and week 12]

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

Mean Change From Baseline in Ocular Surface Staining [Time Frame: At baseline, week 4, week 8, and week 12]

Mean Change From Baseline in Stimulated Salivary Flow Rate [Time Frame: At baseline, week 4, week 8, and week 12]

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

Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI [Time Frame: At week 12]

Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8 [Time Frame: At baseline, week 4 and week 8]

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

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

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]

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

Mean Change in Baseline in ESSPRI Individual Component of Pain [Time Frame: At baseline, week 4, week 8, and week 12]

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

Mean Change From Baseline in Unstimulated Salivary Flow Rate [Time Frame: At baseline, week 4, week 8, and week 12]

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]

Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12 [Time Frame: At week 12]

Secondary ID(s)

IM128-035

2016-000101-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02843659