A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate theEfficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjogren´s Syndrome

Not Applicable

Recruiting

• Conditions: -M350 Sicca syndrome [Sjogren]; Sicca syndrome [Sjogren]; M350

• Registration Number: PER-035-16
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Subjects diagnosed or classified as having moderate to severe primary Sjögren’s syndrome based on the 2015 ACR-EULAR Classification Criteria for Sjögren’s syndrome, with disease duration from time since diagnosis of at least 16 weeks, but not more than 7 years prior to the Screening Visit
2. ESSDAI ≥ 5; including disease activity (any score > 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
3. Positive anti-SS-A/Ro or anti-SS-B/La autoantibody
4. Unstimulated whole saliva secretion > 0.01 mL/min

Exclusion Criteria

Sujetos con:
1.Sindrome de Sjögren secundario.
2.Otras enfermedades autoinmunes sistemicas
3.Una afeccion que podria confundir el diagnostico de pSS,
4.pSS muy severo o complicaciones severas de pSS
5.Infeccion aguda de las glandulas salivales
6.Riesgo de tuberculosis (TB), infeccion bacteriana o infecciones fungicas sistemicas.
7.Sintomas de herpes zoster o evidencia de infeccion bacteriana o viral activa o latente.
8.Intervencion quirurgica mayor o cirugia programada.
9.Que reciben hidroxicloroquina y no tiene documentacion de una evaluacion oftalmologica.
10.Donacion de sangre o transfusion de sangre dentro de las 4 semanas.
11.Incapacidad para tolerar la venipuncion y/o el acceso venoso.
12.Antecedentes conocidos de abuso de drogas o alcohol o de incumplimiento con el tratamiento medico.
13.Administracion de vacunas de virus vivos.
14.Sujetos que no estan dispuestos o tienen dificultad para tragar comprimidos orales.
15.Resultados positivos para HBsAg o anti-HBc o TB IGRA, hepatitis C o para VIH.
16.Corticosteroides orales > 10 mg/dia o intravenosos, intramusculares o intra-articulares.

Study & Design

• Study Type: Interventional
• Study Design: Not specified