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

Phase 1

• Conditions: subjects with moderate to severe Sjögren's syndrome; MedDRA version: 20.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.1Level: PTClassification code 10048676Term: Sjogren-Larsson syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: LLTClassification code 10040765Term: Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-000101-37-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-27
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- Age 18-70 years old
- Subjects diagnosed or classified as having moderate to severe primary Sjögren’s syndrome based on the 2015 ACR-EULAR Classification Criteria
- 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 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

-Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis)
-Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit
-Active systemic bacterial (including tuberculosis), viral or fungal infection, or evidence of prior or current Hepatitis B or C, HIV infection, latent bacterial, viral or fungal infections
-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 other biologics 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified