A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THESAFETY AND EFFICACY OF BMS-931699 VS. PLACEBO ON A BACKGROUND OF LIMITED STANDARD OF CAREIN THE TREATMENT OF SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Not Applicable

Recruiting

• Conditions: -M329 Systemic lupus erythematosus, unspecified; Systemic lupus erythematosus, unspecified; M329

• Registration Number: PER-075-14
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-20
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1) SLE defined by 4 of 11 classification criteria of ACR for SLE (sequentially or coincidently). 2)Subjects must have elevated ANA > to 1:80 via immunofluorescent assay and/or positive anti-dsDNA or anti-Sm above the normal level (all determined by the central laboratory). 3)Subjects must have a SLEDAI greater or equal to 6. At least 4 of the points must be attributable to clinical criteria. Must be confirmed by External Adjudication Committee. 4)Subjects must have at least one of the following manifestations of SLE, which must be confirmed by the External Adjudication committee: BILAG A or B score in the Mucocutaneous body system or BILAG A or B score in the Musculoskeletal body system due to active polyarthritis as defined in protocol. 5) Subjects must be currently receiving at least one of the following: (1)Administration for a minimum of 12 weeks, and a stable dose for at least 56 days (8 weeks) prior to signing consent, of the following steroid sparing agents are permitted: azathioprine (AZA), chloroquine, hydroxychloroquine or methotrexate (MTX) and, (2)Prednisone (or prednisone-equivalent) cannot exceed 30mg/day at screening for a subject to be eligible and must be stable at a maximum of 10 mg/day for at least 5 days prior to Day 1.

Exclusion Criteria

1) Sujetos con LES inducida por farmacos, en lugar de LES idiopatica. 2) Sujetos con otra enfermedad autoinmune. 3) Sujetos con sindrome de anticuerpos antifosfolipido primario como rasgo unico o principal de su LES o sindrome simlar a LES. 4) Sujetos con antecedentes o riesgo para la tuberculosis (TB). 5) Los sujetos con manifestaciones neuropsiquiatricas del lupus activa o inestables y sujetos con nefritis lupica grave activa (OMS clase III, IV). Nota: Se permite re-enrolamientos de pacientes

Study & Design

• Study Type: Interventional
• Study Design: Not specified