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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Lupus

Treatments: Drug: BMS-931699; Drug: Placebo matching BMS-931699

Study type: Interventional

Funder types: Industry

Identifiers

NCT02265744

2014-002184-14 (EudraCT Number)

IM128-027

Details and patient eligibility

About

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

Full description

1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period

2. The LTE period will remain blinded but will no longer have a placebo arm:

   • Subjects will remain on their originally assigned treatment arm unless they were on placebo
   • Subjects initially randomized to placebo arm will be automatically re-randomized into one of the existing active arms at Day 169 (24 weeks)

Enrollment: 730 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Male or female aged between 18 to 70 (included)
• Diagnosed with active systemic lupus erythematosus 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

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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730 participants in 5 patient groups, including a placebo group

Experimental:Arm A: BMS-931699

Experimental group

Description:

12.5mg subcutaneous (SC) injection Weekly dosing

Treatment:

Drug: BMS-931699

Experimental:Arm B: BMS-931699

Experimental group

Description:

12.5mg SC injection Every other Week dosing

Treatment:

Drug: BMS-931699

Experimental:Arm C: BMS-931699

Experimental group

Description:

5mg SC injection Every other Week dosing

Treatment:

Drug: BMS-931699

Experimental:Arm D: BMS-931699

Experimental group

Description:

1.25mg SC injection Every other Week dosing

Treatment:

Drug: BMS-931699

Placebo Comparator: Arm E: Placebo matching BMS-931699

Placebo Comparator group

Description:

0mg SC injection Weekly dosing

Treatment:

Drug: Placebo matching BMS-931699