Lupus Erythematosus, Systemic
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 from both s
Sponsors
Okubo Yusuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening - Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (>=) 24 weeks prior to screening according to european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria - Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 and a clinical SLEDAI-2K >= 4 at screening, AND a clinical SLEDAI-2K score >= 4 points at Week 0, excluding points attributed to lupus headache, alopecia, and organic brain syndrome - Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (b-hCG) test at screening and a negative urine (b-hCG) test at Week 0 prior to randomization - Has at least 1 BILAG#2004 A score or 2 BILAG#2004 B scores observed at screening
Exclusion criteria
Exclusion criteria: - 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 - Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications - 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 - Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins - 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 |
|---|---|
| 1. Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 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 } 10 percent {%} increase from baseline]). [Time Frame: Week 52] | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline IFN Gene Signature (Interferon [IFN] high) 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 10% increase from baseline). IFN high is defined as elevated peripheral type 1 IFN gene signature at baseline. [Time Frame: Week 52] 3. Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with Sustained Reduction in Oral Glucocorticoid (GC) Dose 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 10% increase from baseline). Sustained reduction in oral GC dose at Week 52 is defined as achieving = 2 Active Joints at Baseline Percentage of participants with = 2 active joints at baseline will be reported. [Time Frame: Week 52] 6. Change From Baseline in Lupus Symptoms Joint Pain Score at Week 52 Lupus symptoms joint pain score at Week 52 will be reported. [Time Frame: Baseline, Week 52] 7. Percentage of Participants Achieving Sustained Reduction in Oral GC Dose at Week 52 in Participants Treated with Oral GC >5 mg/Day Prednisone (or equivalent) at Baseline Percentage of participants achieving sustained reduction in oral GC dose at Week 52 in participants treated with oral GC >5 mg/Day prednisone (or equivalent) at baseline will be reported. [Time Frame: Week 52] 8. Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 52 FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst p | — |
Countries
Argentina, Australia, Brazil, Bulgaria, China, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Norway, Poland, Portugal, Romania, Slovakia, Spain, Taiwan Province Of China, Thailand, Turkiye, United Kingdom Of Great Britain, United States of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed