Nipocalimab Clinical Trials (2026): 20 Studies for Healthy & Myasthenia Gravis

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: .

20 Nipocalimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 13 indications (including Healthy & Myasthenia Gravis) and 2,773 total planned enrollment. 7 Phase 3 Nipocalimab trials and 6 Phase 2 are listed. 8 Nipocalimab clinical trials are actively recruiting at 100 U.S. sites across 28 states. Most recent activity: NCT07438496 (Nov 2031).

Where to Participate: All Nipocalimab Trial Sites in the U.S. (100 sites across 28 states)

Every actively recruiting Nipocalimabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
ALThe University of Alabama at BirminghamBirmingham35205NCT06533098Map
AZNeuromuscular Research Center and ClinicParadise Valley85028NCT04951622Map
AZPhoenix Children's HospitalPhoenix85016NCT05265273Map
CADavid S Hallegua MD A Professional CorporationBeverly Hills90211NCT07438496Map
CANeurology Center of North Orange CountyFullerton92835NCT07217587Map
CASouthland Arthritis and Osteoporosis Medical Center Inc dba Southland ArthritisHemet92543NCT07438496Map
CAUniversity of California at San DiegoLa Jolla92037NCT05912517Map
CAAdvanced Medical ResearchLa Palma90623NCT07438496Map
CAChildrens Hospital Los AngelesLos Angeles90027NCT05265273Map
CAKaiser Permanente Los Angeles Medical CenterLos Angeles90027NCT05912517Map
CALucile Packard Children's Hospital StanfordPalo Alto94304NCT05265273Map
CACare Access ResearchPasadena91101NCT04951622Map
CAThe Neurology GroupPomona91767NCT07217587Map
CAUC Davis School of MedicineSacramento95817NCT05912517Map
CAUC Davis School of MedicineSacramento95817NCT06533098Map
CAUCSF Benioff Children's HospitalSan Francisco94158NCT05265273Map
CASolace Clinical Research CaliforniaTustin92780NCT07438496Map
CAInland Rheumatology Clinical Trials Inc.Upland91786NCT07438496Map
COChildren's Hospital ColoradoAurora80045NCT05265273Map
COChildrens Hospital ColoradoAurora80045NCT05912517Map
COChildrens Hospital ColoradoAurora80045NCT06533098Map
COUniversity of Colorado Anschutz Medical CampusAurora80045NCT04951622Map
COIMMUNOe Health and Research CentersCentennial80112NCT05327114Map
COAdvanced Neurology of ColoradoFort Collins80528NCT07217587Map
CTUniversity of ConnecticutFarmington06030NCT07217587Map
CTYale New Haven HospitalNew Haven06519NCT04951622Map
FLArthritis & Rheumatic Disease SpecialtiesAventura33180NCT07438496Map
FLFM Clinical Research, LLC South Florida Neurology Associates, P. A.Boca Raton33487NCT04951622Map
FLSFM Clinical Research LLCBoca Raton33487NCT07217587Map
FLClinical Research of West Florida 1Clearwater33765NCT07438496Map
FLHealthcare Innovations Institute IncCoral Springs33067NCT05327114Map
FLAvanti Clinical Research CorpHialeah33013NCT07438496Map
FLLeJenue Research Associates PLLCMiami33126NCT07438496Map
FLUniversity of MiamiMiami33136NCT05912517Map
FLPro-Care Research Center, Corp.Miami Gardens33014NCT07438496Map
FLFloridian Clinical Research LLCMiami Lakes33016NCT07438496Map
FLMedsol Clinical Research Center IncPort Charlotte33952NCT04951622Map
FLClinical Research of West FloridaTampa33606NCT07438496Map
FLUniversity of South FloridaTampa33612NCT04951622Map
FLUniversity of South Florida Morsani Center for Advanced HealthcareTampa33613NCT05265273Map
GAAtlanta Research Center for RheumatologyMarietta30060NCT07438496Map
ILHSHS St. Elizabeth's HospitalO'Fallon62269NCT07217587Map
ILAdvocate Children's HospitalPark Ridge60068NCT05912517Map
ILAdvocate Children's HospitalPark Ridge60068NCT06533098Map
ILWillow Rheumatology and Wellness PLLCWillowbrook60527NCT07438496Map
INJosephson Wallack Munshower Neurology, PCIndianapolis46256NCT07217587Map
INRiley Children s HospitalIndianapolis46202NCT05912517Map
IAUniversity of Iowa Hospital and ClinicsIowa City52242NCT06533098Map
KSUniversity of Kansas Medical CenterKansas City66160NCT04951622Map
KSUniversity of Kansas Medical CenterKansas City66160NCT05327114Map
KYUniversity of Kentucky Medical CenterLexington40536NCT05912517Map
LAAccurate Clinical Research, Inc.Lake Charles70605NCT07438496Map
MDJohns Hopkins HospitalBaltimore21287NCT05327114Map
MDJohns Hopkins HospitalBaltimore21287NCT05912517Map
MIC.S. Mott Children's HospitalAnn Arbor48109NCT05265273Map
MIHenry Ford HospitalDetroit48202NCT07217587Map
MIRevive Research InstituteSterling Heights48313NCT07438496Map
MNMidwest Fetal Care CenterMinneapolis55404NCT05912517Map
MOKansas City Veterans Affairs Medical CenterKansas City64128NCT05327114Map
NYColumbia University Medical CenterNew York10032NCT05912517Map
NYSouth Shore Neurologic Associates - PatchoguePatchogue11772NCT05327114Map
NYUniversity of Rochester Medical CenterRochester14642NCT06533098Map
NCUniversity of North Carolina (UNC) - School of MedicineChapel Hill27599-7516NCT05912517Map
NCUniversity of North Carolina at Chapel HillChapel Hill27599NCT06533098Map
NCDJL Clinical Research, PLLCCharlotte28211NCT07438496Map
NCJoint and Muscle Research InstituteCharlotte28204NCT07438496Map
NCThe Neurological Institute, PACharlotte28204NCT05327114Map
NCDuke University School of MedicineDurham27710NCT04951622Map
NCCross Creek Medical ClinicFayetteville28304 4422NCT07438496Map
NCVelocity Clinical Research, Inc.Raleigh27607 6010NCT07217587Map
NCAtrium Health Wake Forest BaptistWinston-Salem27157NCT07217587Map
OHUniversity of CincinnatiCincinnati45267NCT05912517Map
OHUniversity of CincinnatiCincinnati45267NCT06533098Map
OHCleveland ClinicCleveland44145NCT04951622Map
OHCleveland Clinic Main CampusCleveland44195NCT05327114Map
OHParamount Medical Research & ConsultingMiddleburg Heights44130NCT07438496Map
OROregon Health and Science UniversityPortland97239NCT05912517Map
OROregon Health And Science UniversityPortland97239NCT06533098Map
PALehigh Valley HospitalAllentown18103-6218NCT05912517Map
PAPenn State Milton S Hershey Medical CtrHershey17033NCT05265273Map
PAChildrens Hospital Of PhiladelphiaPhiladelphia19106NCT05265273Map
PAClinical Research PhiladelphiaPhiladelphia19114NCT07438496Map
PAHospital of the University of PennsylvaniaPhiladelphia19104NCT06533098Map
SCMedical University of South CarolinaCharleston29425NCT04951622Map
TNWest Tennessee Research InstituteJackson38305NCT07438496Map
TXArthritis and Rheumatology Research InstituteAllen75013NCT07438496Map
TXAmarillo Center for Clinical ResearchAmarillo79124NCT07438496Map
TXAustin Neuromuscular CenterAustin78756NCT05327114Map
TXUniversity of Texas Dell Medical School Department of Women's HealthAustin78723NCT05912517Map
TXTexas NeurologyDallas75206NCT07217587Map
TXUniversity of Texas Medical BranchGalveston77555NCT06533098Map
TXUniversity Of Texas Medical Branch At GalvestonGalveston77555NCT05912517Map
TXR and H Clinical ResearchKaty77449NCT07438496Map
TXSouthwest Rheumatology Research LLCMesquite75150NCT07438496Map
TXTexas Rheumatology Research Institute LLCPlano75024NCT07438496Map
TXEpic Medical Research 1Red Oak75154NCT07438496Map
TXFort Bend Rheumatology Associates PLLCSugar Land77479NCT07438496Map
UTUniversity of UtahSalt Lake City84108NCT06533098Map
VAMacon & Joan Brock Virginia Health Sciences at Old Dominion UniversityNorfolk23507NCT05912517Map
WIAdvocate Health - Aurora St. Luke's Medical CenterMilwaukee53215NCT05327114Map

Nipocalimab clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedwithdrawntemporarily not availableTotal
P144
P21416
P2/P322
P3617
N/A11

Recruiting Nipocalimab clinical trials (8)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT07438496GARDENIAA Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus ErythematosusP3Lupus Erythematosus, Systemic600Mar 2026
NCT06533098FREESIA-3A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)P3Thrombocytopenia, Neonatal Alloimmune50Feb 2025
NCT06449651FREESIA-1A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)P3Thrombocytopenia, Neonatal Alloimmune39Nov 2024
NCT05912517AZALEAA Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)P3Hemolytic Disease of the Fetus and Newborn120Dec 2023
NCT07217587EPICComparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia GravisP3Myasthenia Gravis115Jan 2026
NCT05265273A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia GravisP2/P3Myasthenia Gravis12Jul 2022
NCT05327114CIDPEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)P2/P3Polyradiculoneuropathy, Chronic Inflammatory Demyelinating201Sep 2022
NCT04951622A Study of Nipocalimab Administered to Adults With Generalized Myasthenia GravisP3Myasthenia Gravis199Jul 2021

Nipocalimab clinical trials by indication

Healthy (4)

NCTAcronymPhaseStatusTitle
NCT05827874P1completedA Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants
NCT05151692P1completedA Study of JNJ-80202135 in Healthy Chinese Adult Participants
NCT04973566P1completedA Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants
NCT04848558P1completedA Study of Nipocalimab in Healthy Male and Female Participants

Myasthenia Gravis (3)

NCTAcronymPhaseStatusTitle
NCT07217587EPICP3recruitingComparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
NCT05265273P2/P3recruitingA Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
NCT04951622P3recruitingA Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Thrombocytopenia, Neonatal Alloimmune (2)

NCTAcronymPhaseStatusTitle
NCT06533098FREESIA-3P3recruitingA Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT06449651FREESIA-1P3recruitingA Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Arthritis, Rheumatoid (2)

NCTAcronymPhaseStatusTitle
NCT06028438DAISYP2completedA Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
NCT04991753P2completedA Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Lupus Erythematosus, Systemic (1)

NCTAcronymPhaseStatusTitle
NCT07438496GARDENIAP3recruitingA Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Lupus Nephritis (1)

NCTAcronymPhaseStatusTitle
NCT04883619P2withdrawnA Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Sjogrens Syndrome (1)

NCTAcronymPhaseStatusTitle
NCT06741969DAFFODILP3active not recruitingNipocalimab in Moderate to Severe Sjogren's Disease

Hemolytic Disease of the Fetus and Newborn (1)

NCTAcronymPhaseStatusTitle
NCT05912517AZALEAP3recruitingA Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (1)

NCTAcronymPhaseStatusTitle
NCT05327114CIDPP2/P3recruitingEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Myositis (1)

NCTAcronymPhaseStatusTitle
NCT05379634SPIREAP2active not recruitingA Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Sjogren's Syndrome (1)

NCTAcronymPhaseStatusTitle
NCT04968912P2completedA Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Systemic Lupus Erythematosus (1)

NCTAcronymPhaseStatusTitle
NCT04882878P2completedA Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Warm Autoimmune Hemolytic Anemia (1)

NCTAcronymPhaseStatusTitle
NCT05221619N/Atemporarily not availablePost-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

Nipocalimab pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
GARDENIANCT07438496P3recruitingLupus Erythematosus, Systemic600
FREESIA-3NCT06533098P3recruitingThrombocytopenia, Neonatal Alloimmune50
FREESIA-1NCT06449651P3recruitingThrombocytopenia, Neonatal Alloimmune39
AZALEANCT05912517P3recruitingHemolytic Disease of the Fetus and Newborn120
EPICNCT07217587P3recruitingMyasthenia Gravis115
DAFFODILNCT06741969P3active not recruitingSjogrens Syndrome655
SPIREANCT05379634P2active not recruitingMyositis36
DAISYNCT06028438P2completedArthritis, Rheumatoid103

Terminated and withdrawn Nipocalimab trials (1)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

All Nipocalimab trials (20)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT07438496GARDENIAA Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus ErythematosusP3recruiting600Janssen Research & Development, LLCMar 2026
NCT06533098FREESIA-3A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)P3recruiting50Janssen Research & Development, LLCFeb 2025
NCT06449651FREESIA-1A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)P3recruiting39Janssen Research & Development, LLCNov 2024
NCT05912517AZALEAA Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)P3recruiting120Janssen Research & Development, LLCDec 2023
NCT07217587EPICComparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia GravisP3recruiting115Janssen Research & Development, LLCJan 2026
NCT05265273A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia GravisP2/P3recruiting12Janssen Research & Development, LLCJul 2022
NCT05327114CIDPEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)P2/P3recruiting201Janssen Research & Development, LLCSep 2022
NCT06741969DAFFODILNipocalimab in Moderate to Severe Sjogren's DiseaseP3active not recruiting655Janssen Research & Development, LLCDec 2024
NCT04951622A Study of Nipocalimab Administered to Adults With Generalized Myasthenia GravisP3recruiting199Janssen Research & Development, LLCJul 2021
NCT04883619A Study of Nipocalimab in Adult Participants With Active Lupus NephritisP2withdrawn0Janssen Research & Development, LLCJan 2026
NCT05379634SPIREAA Study of Nipocalimab in Participants With Active Idiopathic Inflammatory MyopathiesP2active not recruiting36Janssen Research & Development, LLCJul 2022
NCT04882878A Study of Nipocalimab in Adult Participants With Active Systemic Lupus ErythematosusP2completed228Janssen Research & Development, LLCAug 2021
NCT06028438DAISYA Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid ArthritisP2completed103Janssen Research & Development, LLCAug 2023
NCT04968912A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)P2completed163Janssen Research & Development, LLCSep 2021
NCT05827874A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy ParticipantsP1completed32Janssen Research & Development, LLCApr 2023
NCT05151692A Study of JNJ-80202135 in Healthy Chinese Adult ParticipantsP1completed30Janssen Research & Development, LLCMay 2022
NCT04991753A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid ArthritisP2completed53Janssen Research & Development, LLCOct 2021
NCT04973566A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy ParticipantsP1completed48Janssen Research & Development, LLCAug 2021
NCT04848558A Study of Nipocalimab in Healthy Male and Female ParticipantsP1completed89Janssen Research & Development, LLCMay 2021
NCT05221619Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)temporarily not available0Janssen Research & Development, LLC

Nipocalimab clinical trials: frequently asked questions

How many Nipocalimab clinical trials are there?
20 Nipocalimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 8 are actively recruiting participants. 8 are marked completed.
Are Nipocalimab clinical trials recruiting in 2026?
Yes — 8 Nipocalimab trials are actively recruiting in 2026, with 100 U.S. sites across 28 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Nipocalimab being studied for?
Nipocalimab is being studied for Healthy, Myasthenia Gravis, Thrombocytopenia, Neonatal Alloimmune, Arthritis, Rheumatoid, Myositis and 8 more. The trials are grouped by indication on this page.
What phase is Nipocalimab in?
Nipocalimab clinical trials span 7 Phase 3, 6 Phase 2, 4 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Nipocalimab clinical trials?
The lead sponsor across the most Nipocalimab trials is Janssen Research & Development, LLC. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Nipocalimabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

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