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Nipocalimab

Phase 3

Sjogrens Syndrome | Small molecule | Immunology |Johnson & Johnson|Last Updated: Jul 16, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment655
FDA Designations
FAST_TRACKBREAKTHROUGH_THERAPYORPHAN_DRUGPRIORITY_REVIEW
Clinical trial landscape

Nipocalimab · 19 trials · 11 indications

Phase 3 7Phase 2 7Phase 1 5
NCT07438496A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus ErythematosusLupus Erythematosus, Systemic
RECRUITING600 Analytics
NCT07217587Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia GravisMyasthenia Gravis
RECRUITING115 Analytics
NCT06533098A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)Thrombocytopenia, Neonatal Alloimmune
RECRUITING50 Analytics
NCT06741969Nipocalimab in Moderate to Severe Sjogren's DiseaseSjogrens Syndrome
ACTIVE NOT_RECRUITING655 Analytics
NCT06449651A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)Thrombocytopenia, Neonatal Alloimmune
RECRUITING39 Analytics
NCT05912517A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)Hemolytic Disease of the Fetus and Newborn
RECRUITING120 Analytics
NCT04951622A Study of Nipocalimab Administered to Adults With Generalized Myasthenia GravisMyasthenia Gravis
RECRUITING199 Analytics
PHASE3RECRUITING
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Lupus Erythematosus, SystemicUnlock trial analytics
PHASE3RECRUITING
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
Myasthenia GravisUnlock trial analytics
PHASE3RECRUITING
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Thrombocytopenia, Neonatal AlloimmuneUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens SyndromeUnlock trial analytics
PHASE3RECRUITING
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Thrombocytopenia, Neonatal AlloimmuneUnlock trial analytics
PHASE3RECRUITING
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Hemolytic Disease of the Fetus and NewbornUnlock trial analytics
PHASE3RECRUITING
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Myasthenia GravisUnlock trial analytics
Study Endpoints
Primary Endpoints
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52
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 \[greater than {\>} 10 percent {%} increase from baseline\]).

Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
Baseline, Weeks 8, 10 and 12

Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.

Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Up to 1 Week post birth

Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count \<30\*10\^9/L will be reported.

Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
Baseline to Week 48

ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.

Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death
From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later

Percentage of pregnancies that did not result in fetal loss, IUT, hydrops fetalis, or neonatal death (during the neonatal period) will be reported. Hydrops fetalis is defined as the presence of greater than or equal to(\>=)2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater (\>)5 millimeter \[mm\]). PMA is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).

Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
Baseline, Weeks 22, 23, and 24

Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores.

Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)
From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)
From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
Baseline (Week 0), Week 12

Change from baseline in DAS28-CRP at Week 12 were reported. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity, and C-reactive protein (CRP; in milligrams per liter \[mg/L\]). The set of 28 joint count was based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis.

Stage B: Time to First Occurrence of a Relapse Event
Up to 52 weeks

Stage B time to first occurrence of a relapse event will be reported.

Change from Baseline in Total Serum Immunoglobulin-G (IgG) Levels
Up to 3 years

Change from baseline in total serum IgG levels were reported.

Number of Participants with Infectious Adverse Events (AEs)
Up to 3 years

Number of participants with infectious AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Number of Participants with Serious AEs (SAEs)
Up to 3 years

Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.

Number of Participants with Adverse Events of Special Interests (AESIs)
Up to 3 years

Number of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered an AESI: a) infections that are severe or require intravenous (IV) anti-infective or operative/invasive intervention; b) hypoalbuminemia with albumin less than (\<)20 grams per liter (g/L) \[\<\] 2.0 grams per deciliter \[g/dL\]) c) opportunistic infections and d) Serious and non-serious deep-vein thrombosis (DVT) and/or pulmonary embolism (PE). Any AE occurring at or after the initial administration of study intervention through end of study is treatment emergent.

Number of Participants with Abnormalities in Clinical Laboratory Tests
Up to 3 years

Number of participants with abnormalities in clinical laboratory tests (including chemistry, hematology, coagulation, and urinalysis) will be reported.

Number of Participants with Abnormalities in Vital Signs
Up to 3 years

Number of participants with abnormalities in vital signs including sitting pulse/heart rate, sitting systolic and diastolic blood pressure, and oral temperature (degrees Celsius) will be reported.

Number of Participants with Abnormalities in Physical Examination
Up to 3 years

Number of participants with abnormalities in physical examinations including height, weight, assessments of the skin, head, eyes, ears, nose, throat, neck, thyroid, lungs, heart, abdomen, lymph nodes and extremities will be reported.

Serum Concentration of Nipocalimab over Time
Up to 3 years

Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method.

Clearance (CL) of Nipocalimab
Up to 3 years

CL is defined as the volume of serum from which nipocalimab is completely removed per unit time.

Volume of Distribution (V) of Nipocalimab
Up to 3 years

V is defined as the representation of nipocalimab's propensity to either remain in the serum or redistribute to other tissue compartments.

Half-life (t1/2) of Nipocalimab
Up to 3 years

t1/2 is defined as the time it takes for nipocalimab's active substance in the body to reduce by half.

Steady-state Peak Concentration (Cpeak,ss) of Nipocalimab
Up to 3 years

Cpeak,ss is defined as the peak serum concentration of nipocalimab at steady state.

Steady-state Trough concentration (Ctrough,ss) of Nipocalimab
Up to 3 years

Ctrough,ss will be reported. It is defined as the observed serum concentration of nipocalimab just prior to the beginning of a dosing interval at steady state.

Steady-state Area Under the Curve (AUCss) of Nipocalimab
Up to 3 years

AUCss is defined as the area under the curve for nipocalimab at steady state.

Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52
At Week 52

Percentage of participants who achieve at least minimal improvement (\>=20) in IMACS TIS at Week 52 and on \<=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with idiopathic inflammatory myopathies (IIM). Minimal improvement is defined as IMACS TIS greater than or equal to (\>=) 20 in participants with IIM. The criteria use the 6 IMACS core set measures: physicians' global activity, patient global activity (PtGA), manual muscle testing (MMT)-8, muscle enzymes, myositis disease activity assessment tool (MDAAT), and health assessment questionnaire-disability index (HAQ-DI). The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.

Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24
Baseline to Week 24

The clinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome. The clinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain.

Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
Week 24

SLE SRI-4 composite response is a composite of at least 4-point improvement in SLE Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG), no worsening in Physician's Global Assessment of Disease Activity score (PGA) and not meeting study treatment failure criteria.

Concentration of Nipocalimab in Breast Milk
Up to Day 8

The concentration of nipocalimab in breast milk over a 7-day sampling period (Day 1 up to Day 8) will be reported.

Area Under the Curve for Breast Milk Concentration
Up to 168 hours postdose

Area under the curve for breast milk concentration vs time curve from time 0 to 168 hours post-dose will be reported.

Percentage of Participants with a Positive Anti-tetanus toxoid Immunoglobulin G (Anti-TT IgG) Response at 4 Weeks Post-vaccination
4 Weeks post-vaccination at Week 0 (Up to Week 4)

Percentage of participants with a positive anti-TT IgG response at 4 weeks post-vaccination will be reported. It is defined as pre-vaccination anti-TT IgG antibody titers are less than (\<) 0.16 international units per milliliter (IU/mL) and post-vaccination anti-TT IgG titers are greater than or equal to (\>=) 0.16 IU/mL, or pre-vaccination anti-TT IgG are \>= 0.16 IU/mL and there is at least a 2-fold increase in post-vaccination anti-TT IgG titers.

Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of Nipocalimab
Up to Day 29

AUC(0-last) is defined as area under the serum concentration versus time curve from time 0 to time of the last measurable concentration of nipocalimab.

Area Under the Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC [0-Infinity]) of Nipocalimab
Up to Day 29

AUC (0-Infinity) is defined as area under the analyte concentration versus time curve from time zero to infinite time of nipocalimab.

Last Measurable Serum Concentration (Clast) of Nipocalimab
Up to Day 29

Clast is defined as last measurable serum concentration of nipocalimab.

Maximum Observed Serum Concentration (Cmax) of Nipocalimab
Up to Day 29

Cmax is defined as maximum observed serum concentration of nipocalimab.

Time of Last Measurable Serum Concentration (Tlast) of Nipocalimab
Up To Day 29

Tlast is defined as time of last measurable serum concentration of nipocalimab.

Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nipocalimab
Up to Day 29

Tmax is defined as time to reach the maximum observed serum concentration of nipocalimab.

Apparent Elimination Half-life (T1/2) of Nipocalimab
Up to Day 29

T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of nipocalimab.

Total Systemic Clearance (CL) of Nipocalimab
Up to Day 29

CL is defined as total systemic clearance of nipocalimab after intravenous (IV) administration.

Volume of Distribution (Vz) of Nipocalimab
Up to Day 29

Vz is defined as volume of distribution based on terminal phase after IV administration of nipocalimab.

Part 1: Serum Etanercept Concentration
Up to Day 99

Serum etanercept concentration will be reported.

Part 1: Ratio of Area Under the Concentration-time Curve (AUCR) of Etanercept
Up to Day 99

AUCR is defined as the ratio of area under the concentration-time curve.

Part 1: Area Under the Concentration-time Curve of Etanercept from Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-Last])
Up to Day 99

AUC (0-last) is defined as area under the concentration-time curve of etanercept from time zero to time of last observed quantifiable concentration.

Part 1: Area Under the Concentration-time Curve of Etanercept from Time Zero to Infinite time (AUC [0-Infinity])
Up to Day 99

AUC (0-Infinity) is defined as area under the concentration-time curve of etanercept from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z) where AUC (0-last) is area under the concentration-time curve of etanercept from time zero to time of last observed quantifiable concentration and C(last) is the last observed quantifiable concentration, and lambda(z) is apparent terminal elimination rate constant.

Part 1: Maximum Observed Concentration (Cmax) of Etanercept
Up to Day 99

Cmax is defined as maximum observed concentration of etanercept.

Part 1: Ratio of Maximum Observed Concentration (CmaxR) of Etanercept
Up to Day 99

CmaxR is defined as ratio of maximum observed concentration of etanercept.

Part 1: Time to Reach the Last Observed Measurable Analyte Concentration (Tlast) of Etanercept
Up to Day 99

Tlast is defined as time to reach the last observed measurable analyte concentration of etanercept.

Part 1: Time to Reach the Maximum Observed Concentration (Tmax) of Etanercept
Up to Day 99

Tmax is defined as time to reach the maximum observed concentration of etanercept.

Part 1: Elimination Half-life (t1/2) of Etanercept
Up to Day 99

t1/2 is defined as elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/ lambda(z).

Part 1: Total Apparent Clearance (CL/F) of Etanercept
Up to Day 99

CL/F is total apparent clearance of etanercept following subcutaneous (SC) administration, calculated as dose/AUC (0-infinity).

Part 1: Apparent Volume of Distribution (Vdz/F) of Etanercept
Up to Day 99

Vdz/F is defined as apparent volume of distribution based on the terminal phase after an SC dose, calculated as dose/lambda(z)\*AUC(0-infinity).

Part 2: Change from Baseline in Total Serum Immunoglobulin (Ig) Levels
Baseline up to Day 50

Change from baseline in total serum Ig levels (serum IgG and IgG subtypes) through Day 50 will be reported.

Percentage of Participants with Adverse Events (AEs)
Up to Day 85

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Percentage of Participants with Serious Adverse Event (SAE)
Up to Day 85

A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

Percentage of Participants with Reasonably Related AEs
Up to Day 85

Percentage of participants with reasonably related AEs will be reported. Reasonably related AE is an AE that has a casual relationship with the pharmaceutical/biological agent under study.

Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
Up to Day 85

Percentage of participants with AEs leading to discontinuation of study intervention will be reported. The participants were discontinued from the study by the investigator if the safety reasons or tolerability reasons such as an AE, it is in the best interest of the participant to discontinue study intervention.

Percentage of Participants with Adverse Events of Special Interest (AESIs)
Up to Day 85

Percentage of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered as AESI; a) severe or medically significant or immediately life-threatening infections requiring intravenous (IV) anti-infective or operative/invasive intervention or requiring hospitalization or prolongation of existing hospitalization; b) hypoalbuminemia with albumin less than (\<) 20 grams per liter (g/L). Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Number of Participants with Vital Signs Abnormalities
Up to Day 85

Number of participants with vital signs abnormalities including body temperature, pulse/heart rate, respiratory rate, blood pressure will be reported.

Number of Participants with Electrocardiogram (ECG) Abnormalities
Up to Day 85

Number of participants with ECG abnormalities will be reported.

Number of Participants with Clinical Laboratory Abnormalities
Up to Day 85

Number of participants with clinical laboratory abnormalities related to hematology, serum chemistry and urinalysis will be reported.

Number of Participants with Subcutaneous (SC) Injection-site Reactions
Up to Day 85

Number of participants with SC injection-site reactions will be reported. An injection-site reaction is any AE at a SC study intervention injection-site.

Secondary Endpoints
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline IFN Gene Signature (Interferon [IFN] high)
Week 52
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with Sustained Reduction in Oral Glucocorticoid (GC) Dose
Week 52
Percentage of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) At Week 52
Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NipocalimabEXPERIMENTALParticipants 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.
PlaceboPLACEBO_COMPARATORParticipants 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.
Arm 1: NipocalimabEXPERIMENTALParticipants will receive nipocalimab intravenously (IV), at a loading dose on Day 1 followed by maintenance dosing once every 2 weeks (q2w) until Week 12.
Arm 2: EfgartigimodACTIVE_COMPARATORParticipants will receive efgartigimod IV, once a week for 4 weeks starting from Day 1. Eligible participants will be given the option to switch to Arm 3 between Week 4 and Week 12.
Arm 3: Treatment Switch (Nipocalimab)EXPERIMENTALParticipants previously treated with efgartigimod, who are directly enrolled in this arm, and eligible participants switching from Arm 2 will receive nipocalimab IV at a loading dose on Switch Day 1 followed by maintenance dosing q2w until Switch Week 12.
Arm 2: Intravenous Immunoglobins (IVIG)EXPERIMENTALMaternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk pregnancies. Additionally, prednisone will be added per study protocol. Participants will be gradually tapered off prednisone after delivery as per investigator judgement or maternal participant tolerance.
Nipocalimab Subcutaneous (SC)EXPERIMENTALOLE Phase: Participants from Cohort 1 will receive nipocalimab subcutaneous liquid in vial (SC-LIV) qw until Week 8. Participants with gMG from Cohort 2 who have not received nipocalimab previously, will receive nipocalimab SC-LIV until Week 8. Participants who complete the 8-week treatment period will have the opportunity to continue receiving nipocalimab SC-LIV qw in the Long term extension (LTE) period.
Certolizumab + PlaceboACTIVE_COMPARATORParticipants will receive placebo intravenously (IV) and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by placebo IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.
Certolizumab + NipocalimabEXPERIMENTALParticipants will receive nipocalimab IV and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by nipocalimab IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.
Group 1: PlaceboPLACEBO_COMPARATORParticipants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy.
Group 2: NipocalimabEXPERIMENTALParticipants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy.
Group 2: Nipocalimab Dose 1EXPERIMENTALParticipants will receive nipocalimab dose 1 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).
Group 3: Nipocalimab Dose 2EXPERIMENTALParticipants will receive nipocalimab dose 2 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).
Healthy Lactating ParticipantsEXPERIMENTALA single dose of nipocalimab will be administered to healthy lactating participants on Day 1. Breast milk samples will be collected and pharmacokinetic (PK) assessments will be done for the analysis of nipocalimab concentrations for up to Day 8.
Active Arm:EXPERIMENTALParticipants will receive Nipocalimab loading dose intravenous (IV) infusion at Week 0 followed by tetanus, diphtheria, pertussis (Tdap) and pneumococcal polysaccharide vaccine (PPSV23) vaccine challenge as an intramuscular (IM) injection on Day 3 of Week 0 and additional doses of Nipocalimab IV at Week 2 and 4.
Control Arm:OTHERParticipants will receive PPSV23 and Tdap vaccine challenge as an IM injection on Day 3 of Week 0.
Cohort 1: NipocalimabEXPERIMENTALParticipants will receive a single intravenous (IV) dose of nipocalimab Dose 1 on Day 1.
Cohort 2: NipocalimabEXPERIMENTALParticipants will receive a single IV dose of nipocalimab Dose 2 on Day 1.
Cohort 3: NipocalimabEXPERIMENTALParticipants will receive a single IV dose of nipocalimab Dose 3 on Day 1.
Part 1: Etanercept and NipocalimabEXPERIMENTALParticipants will receive a single subcutaneous (SC) dose of etanercept on Day 1 in Period 1 followed by single intravenous (IV) infusion of nipocalimab on Day 29, SC administration of etanercept followed by an IV infusion of nipocalimab on Day 43 and then a single dose of nipocalimab IV infusion on Day 57 in Period 2 of Part 1. There will be a wash-out period of 28 days between Day 1 of Period 1 and Day 29 of Period 2 in Part 1.
Part 2 (Cohort 1): NipocalimabEXPERIMENTALParticipants will receive a single IV infusion of nipocalimab on Day 1 in Cohort 1 of Part 2.
Part 2 (Cohort 2): Nipocalimab and Hydroxychloroquine (HCQ)EXPERIMENTALParticipants will receive a single oral dose of HCQ film-coated tablets once daily from Day 1 to Day 22 and a single IV infusion of nipocalimab on Day 8 in Cohort 2 of Part 2.
Part 1: Single Dose CohortsEXPERIMENTALParticipants will receive subcutaneous (SC) injection or intravenous (IV) infusion of nipocalimab or placebo in single ascending doses on Day 1 in Cohorts 1-6 and SC administration in optional Cohorts 7-8.
Part 2: Multiple Dose CohortsEXPERIMENTALParticipants will receive up to 4 weekly SC injections of nipocalimab or placebo on Days 1, 8, 15, and 22 in Cohort 1 or 4 biweekly SC injections on Days 1, 15, 29, and 43 in optional Cohort 2.
Interventions
NameTypeDescription
NipocalimabDRUGNipocalimab will be administered.
PlaceboDRUGPlacebo will be administered.
Standard of care treatmentDRUGProtocol-defined topical and systemic standard of care background treatments.
EfgartigimodDRUGEfgartigimod will be administered intravenously.
Intravenous immunoglobulins (IVIG)DRUGIVIG will be administered intravenously.
PrednisoneDRUGPrednisone will be administered orally.
Nipocalimab SC-LIVDRUGNipocalimab will be administered subcutaneously.
CertolizumabDRUGCertolizumab will be administered subcutaneously.
GlucocorticoidsDRUGPrednisone or equivalent will be administered orally as Glucocorticoid.
Standard-of-care treatmentDRUGStandard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.
Breast Milk SamplingOTHERBreast milk sampling at pre-defined time points for 8 days.
TdapBIOLOGICALTdap will be administered as an IM injection.
PPSV23BIOLOGICALPPSV23 will be administered as an IM injection.
EtanerceptDRUGEtanercept will be administered subcutaneously.
HydroxychloroquineDRUGHCQ will be administered orally.
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites222

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 and meeting eu...

Countries:United StatesArgentinaAustraliaBrazilBulgariaChinaCzechiaDenmarkFinlandFranceGermanyGreeceHungaryIsraelItalyJapanMalaysiaNorwayPolandPortugalRomaniaSlovakiaSouth KoreaSpainTaiwanThailandTurkey (Türkiye)United KingdomSwitzerlandAustriaNetherlandsCanadaHong KongMexicoBelgiumSloveniaSwedenIrelandColombiaSouth AfricaUkraine
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Recent Changes (Last 90 Days)
LOWJul 17, 2026NCT07438496lastUpdatePostDate: changed
LOWJul 17, 2026NCT07438496lastUpdatePostDate: changed
LOWJul 17, 2026NCT07438496lastUpdatePostDate: changed
LOWJul 6, 2026NCT06449651lastUpdatePostDate: changed
LOWJul 6, 2026NCT05912517lastUpdatePostDate: changed
LOWJul 6, 2026NCT05265273lastUpdatePostDate: changed
LOWJul 6, 2026NCT06533098Completion: 2029-12-05 → 2029-12-11
LOWJul 6, 2026NCT05327114lastUpdatePostDate: changed
LOWJul 6, 2026NCT07217587Completion: 2029-07-31 → 2029-01-29
LOWJul 6, 2026NCT07669077Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 6, 2026NCT06741969lastUpdatePostDate: changed
LOWJul 6, 2026NCT06449651lastUpdatePostDate: changed
LOWJul 6, 2026NCT05327114lastUpdatePostDate: changed
LOWJul 6, 2026NCT05912517lastUpdatePostDate: changed
LOWJul 6, 2026NCT07217587Completion: 2029-07-31 → 2029-01-29
LOWJul 6, 2026NCT05265273lastUpdatePostDate: changed
LOWJul 6, 2026NCT06533098Completion: 2029-12-05 → 2029-12-11
LOWJul 6, 2026NCT07669077Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 6, 2026NCT06741969lastUpdatePostDate: changed
LOWJun 25, 2026NCT07669077NEW_TRIAL: changed