Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus

Phase 1

Conditions: Active Systemic Lupus Erythematosus
MedDRA version: 17.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2014-002184-14-ES

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

Male or female aged between 18 to 70 (included)
Diagnosed with active systemic lupus erythomatosus by a doctor
Disease must be in patient?s joints or on the skin at a minimum
Taking other medications is allowed but some are excluded
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythomatosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for up to 24 weeks. Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythomatosus studies and patient self reporting.;Secondary Objective: - proportion of subjects who demonstrate an improvement in their SLE Responder Index assessments<br>- proportion of subjects who improve their scores of disease activity<br>- change in the use of other medications;Primary end point(s): Proportion of subjects who achieve a BICLA response (BICLA response rate) at Day 169.;Timepoint(s) of evaluation of this end point: Primary endpoint will be assessed at Day 169.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - proportion of subjects who demonstrate an improvement in their SLE Responder Index assessments<br>- proportion of subjects who improve their scores of disease activity<br>- change in the use of other medications;Timepoint(s) of evaluation of this end point: Secondary endpoints will be assessed at Day 85 and Day 169.