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 | NYU Langone Health

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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:

Conditions:
Systemic Lupus Erythematosus
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:
1. Subjects have signed the Informed Consent Form (ICF) prior to any trial related procedures.
2. Subjects meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for SLE
3. 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
4. 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:

1. Subjects who have history of kidney transplantation or planned transplantation
2. Subjects with Pure ISN/RPS Class V membranous LN
3. Subjects screening estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease [MDRD] equation) = 30 mL/minute/1.73 m2
4. Subjects with End Stage Renal Disease, autoimmune diseases other than SLE
5. Subjects with Antiphospholipid Syndrome (APS)
6. Subjects currently on hydroxychloroquine or chloroquine
7. Subjects are pregnant or breastfeeding
8. Screening systolic blood pressure > 150 and/or diastolic blood pressure > 90 mmHg
9. Body mass index (BMI) = 40 kg/m2 at screening
10. Any major illness/condition, evidence of an unstable clinical condition, or symptoms of a severe, progressive, or uncontrolled condition
11. Any major surgery within 30 days before the first dose of study treatment or any surgery planned during the course of the study
12. Cancer or history of cancer or lymphoproliferative disease within 5 years before screening
13. 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
14. Severe, progressive, or uncontrolled kidney, liver, blood, stomach, lung, heart, or brain disease not due to active SLE
15. Inability to tolerate oral medication
16. Inability to tolerate venipuncture and/or inadequate venous access