A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

December 4, 2025 updated by: Janssen Research & Development, LLC

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

SLE is a complex, immune-mediated inflammatory disorder of unknown etiology that can affect almost any organ system and follows a waxing and waning disease course. In SLE, the immune system attacks the body cells and tissues and the resulting inflammation and tissue damage can harm the heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system. Nipocalimab is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable receptor (FcRn). Thus, nipocalimab, a FcRn antibody, has potential in treatment of SLE through lowering of pathogenic IgGs and immune complexes. The study will consist of a Screening Period (less than or equal to [<=] 6 Weeks), double-blind Treatment Period (52 Weeks), and a Follow-up Period (6 Weeks). Key safety assessments will include adverse events (AEs), serious adverse events (SAEs), adverse events of special interests (AESIs), clinical laboratory tests (hematology, chemistry, urinalysis, and lipid profile) and vital signs. The total duration of the study is up to 64 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Temporarily not available

Temporarily not available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
        • Centro Médico Reumatológico (OMI)
      • Buenos Aires, Argentina, C1417EYG
        • Centro Privado de Medicina Familiar
      • CABA, Argentina, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • Ciudad de Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • La Plata, Argentina, B1900
        • Hospital Italiano La Plata
      • Mar del Plata, Argentina, B7600
        • Centro de Investigaciones Médicas Mar del Plata
      • Mendoza, Argentina, 5000
        • Instituto de Reumatologia - Ir Medical Center S.A.
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Centro de investigaciones medicas Tucuman
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Multiprofile Hospital for Active Treatment Plovdiv
      • Sofia, Bulgaria, 1431
        • Diagnostic-Consultative Center (DCC) Aleksandrovska
      • Sofia, Bulgaria, 1612
        • UMHAT St. Ivan Rilski
  • Colombia
      • Barranquilla, Colombia, 080001
        • Clínica de la Costa SAS
      • Barranquilla, Colombia, 080020
        • Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SAS
      • Bogotá, Colombia, 110221
        • Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
      • Bucaramanga, Colombia
        • Servimed S A S
      • Chía, Colombia
        • IPS Preventive Care SAS
  • Germany
      • Langenau, Germany, 89129
        • Praxis Dr. med. Beate Schwarz - Germany
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig
  • Hungary
      • Budapest, Hungary, 1023
        • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
      • Gyula, Hungary, 5700
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Zalaegerszeg, Hungary, H-8900
        • Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)
  • Japan
      • Chiba, Japan, 260-8712
        • National Hospital Organization Chiba East Hospital
      • Fukuoka, Japan, 810 8563
        • National Hospital Organization Kyushu Medical Center
      • Ichikawa, Japan, 272 8516
        • National Center for Global Health and Medicine Kohnodai hospital
      • Kanagawa, Japan, 216 8511
        • St Marianna University Hospital
      • Kawachi-Nagano, Japan, 586 8521
        • National Hospital Organization Osaka Minami Medical Center
      • Nagoya, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center
      • Osaka, Japan, 545 8586
        • Osaka Metropolitan University Hospital
      • Sendai, Japan, 980 8574
        • Tohoku University Hospital
      • Takatsuki, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital
      • Tokyo, Japan, 104 8560
        • St. Luke's International Hospital
      • Toyoake, Japan, 470-1192
        • Fujita Health University Hospital
      • Tsukuba, Japan, 305 8576
        • University of Tsukuba Hospital
  • Poland
      • Bydgoszcz, Poland, 85 168
        • Szpital Uniwersytecki Nr 2 w Bydgoszczy
      • Bytom, Poland, 41 902
        • Nzoz Bif Med
      • Krakow, Poland, 30363
        • Centrum Medyczne Plejady
      • Krakow, Poland, 30-002
        • Malopolskie Badania Kliniczne Sp z o o
      • Nadarzyn, Poland, 05-830
        • NZOZ Lecznica MAK MED S C
      • Poznan, Poland, 61 113
        • AI Centrum Medyczne
      • Poznan, Poland, 61 397
        • Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj
      • Poznan, Poland, 60-324
        • Twoja Przychodnia Poznańskie Centrum Medyczne
      • Rzeszów, Poland, 35-055
        • Uniwersytecki Szpital Kliniczny w Rzeszowie
      • Warsaw, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
  • South Africa
      • Cape Town, South Africa, 7500
        • Panorama Medical Centre
      • George, South Africa, 6529
        • Excellentis Clinical Trial Consultants
      • Stellenbosch, South Africa, 7600
        • Winelands Rheumatology Centre
  • Spain
      • Barcelona, Spain, 08035
        • Hosp Univ Vall D Hebron
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Pamplona, Spain, 31008
        • Hosp. de Navarra
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 88301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 11031
        • Taipei Medical University
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • Municipal Non-Profit Enterprise 'Chernihiv Regional Hospital' of Chernihiv Regional Council
      • Kharkiv, Ukraine, 61204
        • Municipal Non-Profit Enterprise of Kharkiv Regional Council 'Regional Clinical Hospital'
      • Kyiv, Ukraine, 03049
        • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
      • Kyiv, Ukraine, 04050
        • Medical Center 'Consylium Medical'
      • Kyiv, Ukraine, 03037
        • Medbud-Clinic LLC
      • Kyiv, Ukraine, 02091
        • Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
      • Odesa, Ukraine, 65025
        • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
      • Poltava, Ukraine, 36011
        • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
      • Vinnytsia, Ukraine, 21018
        • MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
      • Zaporizhzhya, Ukraine, 69600
        • Medical Center LLC 'Modern Clinic'
  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Valerius Medical Group & Research Center
      • Rancho Mirage, California, United States, 92270
        • Desert Medical Advances
      • Santa Ana, California, United States, 92705
        • Wolverine Clinical Trials
      • Westlake Village, California, United States, 91361
        • Millennium Clinical Trials LLC
    • Florida
      • Brandon, Florida, United States, 33511
        • Bay Area Arthritis And Osteoporosis
      • Cooper City, Florida, United States, 33024
        • Gnp Research
      • Miami, Florida, United States, 33136
        • South Coast Research Center
      • Ocoee, Florida, United States, 34761
        • Advanced Clinical Research of Orlando
      • Orlando, Florida, United States, 32808
        • Omega Research Consultants
      • Ormond Beach, Florida, United States, 32174
        • Millennium Research
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • North Georgia Rheumatology, PC
      • Marietta, Georgia, United States, 30060
        • Atlanta Research Center for Rheumatology
    • Missouri
      • St Louis, Missouri, United States, 63131
        • West County Rheumatology
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • DJL Clinical Research, PLLC
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research & Consulting
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Dr. Ramesh Gupta
    • Texas
      • Allen, Texas, United States, 75013
        • Arthritis and Rheumatology Research Institute
      • Colleyville, Texas, United States, 76034
        • Precision Comprehensive Clinical Research Solutions
      • Mesquite, Texas, United States, 75150
        • Southwest Rheumatology Research LLC
      • Red Oak, Texas, United States, 75154
        • Epic Medical Research
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology and Pulmonary Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a clinical diagnosis of systemic lupus erythematosus (SLE) greater than or equal to (>=) 6 months prior to the screening visit and according to Systemic Lupus International Collaborating Clinics (SLICC)-2012 classification criteria: at least 4 criteria fulfilled, with at least 1 clinical criterion and 1 immunologic criterion
  • Has at least 1 BILAG (british isles lupus assessment group) A and/or 2 BILAG B scores observed during screening
  • Must have at least moderately active SLE, as defined as systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must also have SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization
  • Has a CLASI (cutaneous lupus erythematosus disease area and severity index) activity score of at least 6 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation (active joints) at screening or at Week 0, or both
  • At least 1 unequivocally positive autoantibody test including antinuclear antibodies (ANA) (>= 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies (level >= 75 international units/milliliter [IU/mL]) and/or anti-Smith antibodies (>120 Absorbance unit/milliliter [AU/mL]) detected during screening
  • Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments prior to first administration of study intervention at a stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs

Exclusion Criteria:

  • Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active lupus nephritis (LN). Have severe active LN as determined by sponsor (or designee) adjudication. Control of renal disease must be documented with at least 2 measurements of proteinuria or urine protein/creatinine ratio (UPCR) over the 6 months prior to screening
  • Has any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
  • Confirmed or suspected inflammatory diseases that might confound the evaluations of efficacy
  • Has a severe infection including opportunistic infections requiring parenteral anti-infectives, and/or hospitalization within 8 weeks prior to screening
  • Has received a single B-cell targeting agent within 3 months prior to first administration of study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Group 1: Placebo
Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids [GCs]).
Other: Placebo
Placebo will be administered intravenously.
Drug: Standard-of-care treatment
Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.
Experimental: Group 2: Nipocalimab Dose 1
Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Drug: Nipocalimab
Nipocalimab dose 1 and dose 2 will be administered intravenously.
Other Names:
  • JNJ-80202135
  • M281
Drug: Standard-of-care treatment
Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.
Experimental: Group 3: Nipocalimab Dose 2
Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Drug: Nipocalimab
Nipocalimab dose 1 and dose 2 will be administered intravenously.
Other Names:
  • JNJ-80202135
  • M281
Drug: Standard-of-care treatment
Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
Time Frame: 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.
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Concentration of Nipocalimab Over Time
Time Frame: Up to Week 58
Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.
Up to Week 58
Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])
Time Frame: Up to Week 58
Number of participants with antibodies to nipocalimab (ADAs and Nabs) in participants receiving active study intervention will be reported.
Up to Week 58
Percentage of Participants with Baseline Active Mucocutaneous Lupus Manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] Activity Score >= 6) Achieving >= 50 Percent (%) Reduction in the CLASI Activity Score at Week 24
Time Frame: Week 24
Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 24 will be reported in participants with a CLASI Activity Score of 6 or greater at baseline. Cutaneous lupus disease activity and severity will be measured by the CLASI. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI consists of 2 scores; the first summarizes the activity of the disease while the second is a measure of the damage caused by the disease.
Week 24
Percentage of Participants with Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving >= 50% Reduction in Active Joints at Week 24
Time Frame: Week 24
Percentage of participants with baseline arthritis (with at least 4 active joints at baseline) achieving >= 50% reduction in active joints at Week 24 will be reported.
Week 24
Percentage of Participants with >= 4 Point Improvement in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24
Time Frame: Week 24
Percentage of participants achieving at least 4 point improvement in SLEDAI-2K will be reported. The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE participants at the time of the visit or in the previous 30 days; the index is weighted according to the feature. Features are scored by the assessing physician if present at the time of the visit or within the last 30 days, with more severe features having higher scores, and then simply added to determine the total SLEDAI-2K score, which ranges from 0 to 105, with higher scores representing increased disease activity.
Week 24
Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24
Time Frame: Week 24
Percentage of participants achieving BICLA Response (BILAG-2004 disease activity improvement without worsening, and without worsening of SLEDAI-2K or PGA compared to baseline) at Week 24 will be reported.
Week 24
Time to First Flare Through Week 24
Time Frame: Up to Week 24
Time to first flare through Week 24, with flare defined as either 1 or more new BILAG A or 2 or more new BILAG B scores will be reported.
Up to Week 24
Percentage of Participants Achieving SRI-4 Composite Response at Week 52
Time Frame: Week 52
Percentage of participants achieving SRI-4 composite response at Week 52 will be reported.
Week 52
Percentage of Participants Receiving >= 10 milligram/day (mg/day) Prednisone or Equivalent at Baseline who Achieve Week 6-16 Glucocorticoid (GC) Taper Goal (at Week 16 to <= 7.5 mg/day Prednisone or Equivalent) and Maintain that Reduction Until Week 24
Time Frame: Up to Week 24
Percentage of participants receiving >= 10 mg/day prednisone or equivalent at baseline who achieve Week 6-16 GC taper goal (at Week 16 to <= 7.5 mg/day prednisone or equivalent) and maintain that reduction until Week 24 will be reported.
Up to Week 24
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 58
Time Frame: Up to Week 58
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Up to Week 58
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) Through Week 58
Time Frame: Up to Week 58
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. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Up to Week 58
Percentage of Participants with Treatment-emergent Adverse Events of Special interests (AESIs) Through Week 58
Time Frame: Up to Week 58
Percentage of participants with treatment-emergent AESIs will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: infections that are severe or require intravenous anti-infective or operative/invasive intervention, hypoalbuminemia with albumin less than (<) 20 gram/liter (g/L) (<2.0 gram/deciliter [g/dL]).
Up to Week 58
Percentage of Participants with Treatment-emergent AEs leading to treatment discontinuation Through Week 58
Time Frame: Up to Week 58
Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported.
Up to Week 58
Number of Participants with Change from Baseline in Laboratory Parameters Over Time
Time Frame: Up to Week 58
Number of participants with change from baseline in laboratory parameters (hematology, chemistry, urinalysis and lipid profile) over time will be reported.
Up to Week 58
Number of Participants with Change from Baseline in Vital Signs Parameters Over Time
Time Frame: Up to Week 58
Number of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Up to Week 58

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR109011
  • 2020-005569-14 (EudraCT Number)
  • 80202135SLE2001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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