A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus

Phase 2

Completed

Conditions: Systemic Lupus Erythematosus
10003816

Registration Number: NL-OMON43900

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

* Male and female subjects, ages 18-70 years inclusive
* Satisfying the SLE classification criteria of the American College of Rheumatology (1982), as revised by the College in 1997, with elevated titer of anti nuclear antibodies at Screening, active features of SLE, including at least one adjudicated BILAG B or greater due to arthritis and/or inflammatory skin disease.
* Unless intolerant, subjects must be on background therapy for 12 weeks, on a stable dose for at least 8 weeks, with at least one steroid sparing agent, including azathioprine (AZA), leflunomide, methotrexate (MTX), anti-malarial agents, mycophenolate mofetil/ mycophenolic acid, which must remain on stable dose throughout the study.
* Prednisone is not required; however, if subject is taking prednisone (or prednisone-equivalent), the maximum dose must not exceed 30mg/day of prednisone (or prednisone equivalent) at screening for a subject to be eligible and must be at a maximum of 10mg/day for at least 5 days prior to Day 1. Subjects must not have SLE manifestations or other disorders expected to require increase in corticosteroids (CS) during the study.
* Any other immunossuppressive or biologic drug will require washout periods indicated in Appendix 2 of the protocol prior to signing consent.
* If subjects receive chronic therapy with NSAIDs (including marketed COX-2 inhibitors), doses must be stable for 14 days prior to first dose of study medication on Day 1 (randomization) and are recommended to remain stable throughout the study.

Exclusion Criteria

* Subjects with drug-induced SLE, rather than *idiopathic* SLE.
* Subjects with other autoimmune disease.
* Subjects with primary anti-phospholipid antibody syndrome as the sole or primary feature of their SLE or SLE-like syndrome.
* Any major surgery within 6 weeks of study drug administration (Day 1) or any elective surgery planned during the course of the study.
* Subjects with any history or risk for tuberculosis (TB).
* Subjects with active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG *A* criteria, with the exception of mononeuritis multiplex and polyneuropathy, which are allowed.
* Subjects with active, severe, lupus nephritis (WHO class III, IV) which requires or may require treatment with cytotoxic agents or high dose corticosteroids.
* Subjects with herpes zoster that resolved less than 2 months prior to screening.
* Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential screening, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection as defined by positivity of HIV-1 and HIV 2 antibody.
* Subjects currently on hydroxychloroquine or chloroquine with evidence of retinopathy within 6 months of screening or who have had no ophthalmologic evaluation within one year of screening and will not have this examination done or who are unwilling or unable to have regular ophthalmologic examinations while participating in the study.
* Concomitant illness that, in the opinion of the investigator, is likely to require additional systemic glucocorticosteroid therapy during the study
* Female subjects with a breast cancer screening suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
* Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to randomization (Day 1 treatment). Carcinoma in situ, treated with definitive surgical intervention, is allowed.
* Subjects with any acute and/or chronic serious bacterial or viral infection (such as pneumonia, renal infection and sinusitis).
* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
* Blood transfusion within 4 weeks of study drug administration.
* Any other sound medical, psychiatric and/or social reason as determined by the investigator.
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
* Positive hepatitis-B surface antigen
* Positive hepatitis-C antibody with positive Recombinant ImmunoBlot Assay (RIBA) or Polymerase Chain Reaction (PCR)
* White blood cells (WBC) < 1,200/mm3 (1.2 x 109/L)
* Platelets < 50,000/mm3 (50 x 109/L)
* Hemoglobin < 8g/dL or < 7g/dL if due to hemolytic anemia related to SLE
* Proteinuria > 3.0g/day (3000 mg/day) or equivalent level of proteinuria as assessed by protein/creatinine ratio (3 mg/mg or 339 mg/mmol).
* serum creatinine > 2.0 mg/dL
* Active urinary sediment
*