Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Lupus Nephritis

Treatments: Drug: Abatacept; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705367

IM101-217

Details and patient eligibility

About

The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
• Stable renal disease
• No flaring of other organ systems in a minimum of the last 3 months

Exclusion criteria

• Unstable lupus nephritis and serum creatinine >3 mg/dL
• Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
• Severe unstable, refractory, or progressive SLE
• History of cancer
• Participants at risk for tuberculosis
• Autoimmune disease other than SLE as main diagnosis
• Human immunodeficiency virus or herpes zoster infection
• Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Abatacept, 30 mg/kg

Active Comparator group

Treatment:

Drug: Abatacept

Drug: Abatacept

Abatacept, 10 mg/kg

Other group

Description:

Open-label long-term extension phase

Treatment:

Drug: Abatacept

Drug: Abatacept