A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT07438496
Other Study ID Numbers:
80202135SLE3001
First Submitted
February 22, 2026
First Posted
February 26, 2026
Last Update Posted
May 7, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Lupus Erythematosus, Systemic
Drug: NipocalimabDrug: Nipocalimab

Study Design

Study TypeInterventional
Actual Enrollment600 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Study Start DateMarch 4, 2026
Actual Primary Completion Date2yrs 6mos from now
Actual Study Completion Date5yrs 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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 studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
Drug: Nipocalimab
Nipocalimab will be administered.
Placebo
Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
Drug: Nipocalimab
Nipocalimab will be administered.

Outcome Measures

Primary Outcome Measures
  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 \<= 1 new B items compared to baseline, no worsening in Physician's Global Assessment (PGA \[greater than {\>} 10 percent {%} increase from baseline\]).
Secondary Outcome Measures
  1. 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 \<= 1 new B items compared to baseline, no worsening in PGA (\> 10% increase from baseline). IFN high is defined as elevated peripheral type 1 IFN gene signature at baseline.
  2. 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 \<= 1 new B items compared to baseline, no worsening in PGA (\> 10% increase from baseline). Sustained reduction in oral GC dose at Week 52 is defined as achieving \<= 5 mg/day oral prednisone (or equivalent) AND no increase of that dose from Week 32 through Week 52.
  3. Percentage of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) At Week 52
    LLDAS is defined as follows: SLEDAI-2K \<= 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia 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 with the previous assessment measured as no new or worsening individual BILAG parameters, physician's global assessment of disease activity \<= 1 on a 3-point visual analog scale from no disease activity to severe disease activity, a current prednisolone (or equivalent) dose \<= 7.5 milligram (mg) daily and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.
  4. Percentage of Participants with < 2 Active Joints at Week 52 in Participants with >= 2 Active Joints at Baseline
    Percentage of participants with \&lt; 2 active joints at Week 52 in participants with \&gt;= 2 active joints at baseline will be reported.
  5. Change From Baseline in Lupus Symptoms Joint Pain Score at Week 52
    Lupus symptoms joint pain score at Week 52 will be reported.
  6. 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 \&gt;5 mg/Day prednisone (or equivalent) at baseline will be reported.
  7. 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 possible score and 52 the best.
  8. Percentage of Participants With BILAG Flare Free Status Through Week 52
    A participant has a flare-free status if no flare has been reported during the 52-week treatment period. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit.
  9. Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline Autoantibodies (Autoantibody 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 \&lt;= 1 new B items compared to baseline, no worsening in PGA (\&gt; 10% increase from baseline). Autoantibody high participants is defined as participants with high autoantibody at baseline.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 (β-hCG) test at screening and a negative urine (β- 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
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

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
David S Hallegua MD A Professional Corporation | Beverly Hills California, United States, 90211Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis | Hemet California, United States, 92543Advanced Medical Research | La Palma California, United States, 90623Solace Clinical Research California | Tustin California, United States, 92780Inland Rheumatology Clinical Trials Inc. | Upland California, United States, 91786Arthritis & Rheumatic Disease Specialties | Aventura Florida, United States, 33180Clinical Research of West Florida 1 | Clearwater Florida, United States, 33765Avanti Clinical Research Corp | Hialeah Florida, United States, 33013LeJenue Research Associates PLLC | Miami Florida, United States, 33126Floridian Clinical Research LLC | Miami Lakes Florida, United States, 33016Clinical Research of West Florida | Tampa Florida, United States, 33606Willow Rheumatology and Wellness PLLC | Willowbrook Illinois, United States, 60527Accurate Clinical Research, Inc. | Lake Charles Louisiana, United States, 70605Joint and Muscle Research Institute | Charlotte North Carolina, United States, 28204DJL Clinical Research, PLLC | Charlotte North Carolina, United States, 28211Cross Creek Medical Clinic | Fayetteville North Carolina, United States, 28304 4422Paramount Medical Research & Consulting | Middleburg Heights Ohio, United States, 44130Clinical Research Philadelphia | Philadelphia Pennsylvania, United States, 19114West Tennessee Research Institute | Jackson Tennessee, United States, 38305Arthritis and Rheumatology Research Institute | Allen Texas, United States, 75013Amarillo Center for Clinical Research | Amarillo Texas, United States, 79124R and H Clinical Research | Katy Texas, United States, 77449Southwest Rheumatology Research LLC | Mesquite Texas, United States, 75150Texas Rheumatology Research Institute LLC | Plano Texas, United States, 75024ARCIS Salud SRL Aprillus asistencia e investigacion | Buenos Aires , Argentina, C1406AGACentro Privado de Medicina Familiar | Buenos Aires , Argentina, C1417EYGCentro de Investigacion en Enfermedades Reumaticas CIER | Ciudad de Buenos Aires , Argentina, C1055Arsema | Ciudad de Buenos Aires , Argentina, C1427Instituto de Investigaciones Clinicas Quilmes | Quilmes , Argentina, B1878GEGMR Medicina Reumatologica | San Fernando , Argentina, B1646GHPHospital das Clinicas - UFG | Goiânia , Brazil, 74605-020Hospital De Clinicas De Porto Alegre | Porto Alegre , Brazil, 90035-903LMK Servicos Medicos S S | Porto Alegre , Brazil, 90480 000Fundacao do ABC Centro Universitario FMABC | Santo André , Brazil, 09060 870Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base | São José do Rio Preto , Brazil, 15090 000ESHO Empresa De Servicos Hospitalares S A | São Paulo , Brazil, 01232 010Peking University People's Hospital | Beijing , China, 100044Linfen Central Hospital | Linfen , China, 041000Ningbo medical center lihuili hospital | Ningbo , China, 315041Shenshan Medical Center Memorial Hospital of Sun Yat Sen University | Shanwei , China, 516601Shanxi Bethune Hospital | Taiyuan , China, 030032Rambam Health Care Campus | Haifa , Israel, 3109601Carmel Medical Center | Haifa , Israel, 3436212Hadassah Ein-Qarem Medical Center | Jerusalem , Israel, 9112001Meir Medical Center | Kfar Saba , Israel, 4428164Galilee Medical Center | Nahariya , Israel, 2210001Tel Aviv Sourasky Medical Center | Tel Aviv , Israel, 6423906Tokai University Hospital | Isehara , Japan, 259-1193Shinkenko Clinic | Naha , Japan, 900 0015St. Luke's International Hospital | Tokyo , Japan, 104 8560Hospital Sultan Ismail | Johor Bahru , Malaysia, 81100University Malaya Medical Centre | Kuala Lumpur , Malaysia, 59100Hospital Umum Sarawak | Kuching , Malaysia, 93586Sunway Medical Centre | Petaling Jaya , Malaysia, 47500Hospital Taiping | Taiping , Malaysia, 34000NTU Biomedical Park Hospital | Hsinchu , Taiwan, 302058Kaohsiung Veterans General Hospital | Kaohsiung City , Taiwan, 813414Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City , Taiwan, 83301Taipei Veterans General Hospital | Taipei , Taiwan, 11217Linkou Chang Gung Memorial Hospital | Taoyuan , Taiwan, 333Ankara University Medical Faculty | Ankara , Turkey (Türkiye), 06050Ankara Bilkent Sehir Hastanesi | Ankara , Turkey (Türkiye), 06800Firat University Hospital | Elâzığ , Turkey (Türkiye), 23200Sanko Universitesi Hastanesi | Gaziantep , Turkey (Türkiye), 27090Marmara University Istanbul Pendik Education and Research Hospital | Istanbul , Turkey (Türkiye), 34899Necmettin Erbakan University Meram Medical Faculty | Konya , Turkey (Türkiye), 42080Peterborough City Hospital | Peterborough , United Kingdom, PE3 9GZSouthampton University Hospital | Southampton , United Kingdom, SO16 6HUHaywood Hospital | Stoke-on-Trent , United Kingdom, ST6 7AG