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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 Sjogren´s Syndrome

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 Sjogren´s Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-035-16
Enrollment
20
Registered
2017-01-19
Start date
2017-05-31
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Subjects with moderate to severe primary Sjögren’s syndrome will receive lulizumab, BMS-986142, or matching placebos for up to 12 weeks, followed by a 6-week follow-up period. Upon meeting the Inclusi

Sponsors

BRISTOL MYERS SQUIBB COMPANY,
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Countries

Canada, Chile, Colombia, France, Germany, Italy, Mexico, Netherlands, Poland, United Kindgdom, United States

Contacts

Public ContactSTELA LOPEZ

BRISTOL MYERS SQUIBB PERU S.A.

stela.lopez@bms.com4116200

Outcome results

None listed

Source: REPEC (via WHO ICTRP)