A Phase 3 interventional study of Nipocalimab and Placebo in Lupus Erythematosus, Systemic, sponsored by Janssen Research & Development, LLC. Recruiting at 272 sites in 33 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 600 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:-
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Standard of care treatment
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 · Drug: Placebo · Drug: Standard of care treatment
Nipocalimab will be administered.
Placebo will be administered.
Protocol-defined topical and systemic standard of care background treatments.
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 \[greater than {\>} 10 percent {%} increase from baseline\]).
Time frame: Week 52
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.
Time frame: Week 52
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.
Time frame: Week 52
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.
Time frame: Week 52
Percentage of Participants with < 2 Active Joints at Week 52 in Participants with >= 2 Active Joints at Baseline
Percentage of participants with \< 2 active joints at Week 52 in participants with \>= 2 active joints at baseline will be reported.
Time frame: Week 52
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
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
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.
Time frame: Baseline, Week 52
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.
Time frame: Up to Week 52
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 \<= 1 new B items compared to baseline, no worsening in PGA (\> 10% increase from baseline). Autoantibody high participants is defined as participants with high autoantibody at baseline.
Time frame: Week 52
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Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · innovativemedicine.jnj.com
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Nipocalimab
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