Systemic lupus erythematosus Musculoskeletal Diseases
Conditions
Interventions
Experimental: Nipocalimab
Participants will receive nipocalimab up to Week 52 in the double-blind treatment period along with standard of care treatments. At Week 52, eligible participants will have t
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old 2. Male or female 3. Medically stable on the basis of physical examination, medical history, vital signs and a 12-lead electrocardiogram (ECG) performed at screening 4. A clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to 24 weeks before screening. This diagnosis should be made according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria. 5. Participants must have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to 6 and a Clinical SLEDAI-2K greater than or equal to 4 at screening, AND a clinical SLEDAI-2K score greater than or equal to 4 points at Week 0, excluding points attributed to “lupus headache,” “alopecia,” and “organic brain syndrome”. 6. Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) test at screening and a negative urine (ß- hCG) test at Week 0 before randomisation 7. Participants must have at least one BILAG#2004 (British Isles Lupus Assessment Group#2004) A score or two BILAG#2004 B scores observed at screening
Exclusion criteria
Exclusion criteria: 1. History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory tests 2. Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications 3. Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant 4. Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins 5. Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 composite response at Week 52 (end of the double-blind treatment period). The SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLE Disease Activity Index 2000 (SLEDAI-2K), no British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as no new A or less than or equal to 1 new B items compared to baseline and no worsening in Physician's Global Assessment (PGA) (which is defined as a 10% or more increase compared to baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants achieving an SLE SRI-4 composite response at Week 52 with a high baseline IFN gene signature (‘Interferon [IFN] high’). The SLE SRI-4 composite response is a composite response of at least a 4-point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or 1 or fewer new B items compared to baseline and no worsening in PGA (more than 10% increase from baseline). ‘IFN high’ is defined as an elevated peripheral type 1 IFN gene signature at baseline. 2. Percentage of participants achieving SRI-4 composite response at Week 52 with a sustained reduction in oral glucocorticoid (GC) dose. A sustained reduction in oral GC dose at Week 52 is defined as achieving less than or equal to 5 mg/day oral prednisone (or equivalent) AND no increase in that dose from Week 32 until Week 52. 3. Percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 52. LLDAS is defined as follows: SLEDAI-2K of 4 or less with no activity in the major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no haemolytic anaemia or gastrointestinal activity measured as maintaining a ‘D’ (no disease activity but suggests the system had previously been affected) or ‘E’ (no current or previous disease activity) score in BILAG gastrointestinal body system; no new lupus disease activity compared to the previous assessment measured as no new or worsening individual BILAG parameters; physician's global assessment of disease activity of one or less on a three-point visual analogue scale from no disease activity to severe disease activity; a current prednisolone (or equivalent) dose of 7.5 mg or less daily and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. 4. Percentage of participants with two or fewer active joints at Week 52 in participants with two or more active joints at baseline. Percentage of participants with =2 active joints at baseline will be r | — |
Countries
Argentina, Australia, Brazil, Bulgaria, China, Colombia, Czech Republic, Denmark, England, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, South, Malaysia, Mexico, Norway, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Türkiye, United Kingdom, United States of America
Outcome results
None listed