Systemic Lupus Erythematosus
Conditions
Interventions
investigational material(s)
Generic name etc : Lulizumab pegol
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for In
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Major Inclusion Criteria: (1) Subjects must have SLE as defined by meeting 4 of the 11 classification criteria of the American College of Rheumatology for the classification of SLE, either sequentially or coincident. The 4 criteria need not be present at study entry, but have occurred at some time during the course of the disease and be documented. (2) Subjects must have elevated ANA  1:80 via immunofluorescent assay at the central laboratory or anti-dsDNA or anti-Sm above the normal level as determined by the central laboratory. (3) BILAG A or B score in the Mucocutaneous body system, OR BILAG A or B score in the Musculoskeletal body system due to active polyarthritis defined as the ptrotocol. (4) Unless intolerant, subjects must be currently receiving at least one of the following steroid-sparing agents for a minimum of 12 weeks, and at stable dose for at least 8 weeks (56 days) prior to signing consent: Azathioprine , chloroquine, hydroxychloroquine, methotrexate, leflunomide, mycophenolate mofetil/mycophenolic acid (5) Prednisone is not required; however, if subject is taking prednisone (or prednisoneequivalent), dose cannot exceed 30 mg/day at screening for a subject to be eligible and must be stable at a maximum of 10 mg/day for at least 5 days prior to Day 1 (randomization).
Exclusion criteria
Exclusion criteria: Major Exclusion Criteria: (1) Subjects with drug-induced SLE, rather than "idiopathic" SLE. (2) Subjects with other autoimmune disease [(for example rheumatoid arthritis (RA), multiple sclerosis (MS)]. (Note: Subjects with type I diabetes mellitus, thyroid autoimmune disease and secondary Sjögren syndrome are eligible.) (3) Subjects with any history or risk for tuberculosis (TB). (4) Subjects with active or unstable lupus neuropsychiatric manifestations. (5) Subjects with active, severe, lupus nephritis (WHO class III, IV) which requires or may require treatment with cytotoxic agents or high dose corticosteroids. (6) Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential screening. (7) 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The proportion of subjects who achieve BICLA response (BICLA response rate) The proportion of subjects who achieve BICLA response (BICLA response rate) at Day 169. BICLA response woll include BILAG-2004 Index, SLEDAI 2K, Physicians Global Assessment of Disease Activity (MDGA), Subjects Global Assessment of Disease Activity (PGA), ACR28 - joint count, etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Major Secondary Endopoint: Proportion of subjects who meet response criteria for the SRI 4, 5, 6 Proportion of subjects with BICLA response Change from baseline in CLASI score Change from baseline in arthritis The cumulative corticosteroid and immunosuppressant use over time Major Secondary Assessment: Proportion of subjects who meet response criteria for the SRI 4, 5, 6at Day 85 and 169 Proportion of subjects with BICLA response at Day 85 Change from baseline in CLASI score at Day 85 and Day 169 Change from baseline in arthritis at Day 85 and at Day 169 The cumulative corticosteroid and immunosuppressant use over time | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed