A Phase 2 Randomized Double-blind Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Systemic Lupus Erythematosus
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Age: Between 18 years - 100 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects have signed the Informed Consent Form (ICF) prior to any trial related procedures.
- Subjects meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for SLE
- Subjects have renal biopsy confirming a histologic diagnosis of active LN ISN/RPS Classes III (A or A/C), IV-S (A or A/C), or IV-G (A or A/C); or Class V
- Required discontinuation periods for other immunomodulatory drugs or biologic drugs must be met as outlined in protocol
You may not be eligible for this study if the following are true:
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- Subjects who have history of kidney transplantation or planned transplantation
- Subjects with Pure ISN/RPS Class V membranous LN
- Subjects screening estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease [MDRD] equation) = 30 mL/minute/1.73 m2
- Subjects with End Stage Renal Disease, autoimmune diseases other than SLE
- Subjects with Antiphospholipid Syndrome (APS)
- Subjects currently on hydroxychloroquine or chloroquine
- Subjects are pregnant or breastfeeding
- Screening systolic blood pressure > 150 and/or diastolic blood pressure > 90 mmHg
- Body mass index (BMI) = 40 kg/m2 at screening
- Any major illness/condition, evidence of an unstable clinical condition, or symptoms of a severe, progressive, or uncontrolled condition
- Any major surgery within 30 days before the first dose of study treatment or any surgery planned during the course of the study
- Cancer or history of cancer or lymphoproliferative disease within 5 years before screening
- New York Heart Association (NYHA) Class III or IV congestive heart failure or any recent onset of heart failure resulting in NYHA Class III/IV symptoms
- Severe, progressive, or uncontrolled kidney, liver, blood, stomach, lung, heart, or brain disease not due to active SLE
- Inability to tolerate oral medication
- Inability to tolerate venipuncture and/or inadequate venous access
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.