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

May 7, 2026 updated by: Janssen Research & Development, LLC

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

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).

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
600

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 3

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, C1417EYG
        • Recruiting
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Argentina, C1406AGA
        • Recruiting
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • Ciudad de Buenos Aires, Argentina, C1055
        • Recruiting
        • Centro de Investigacion en Enfermedades Reumaticas CIER
      • Ciudad de Buenos Aires, Argentina, C1427
        • Recruiting
        • Arsema
      • Quilmes, Argentina, B1878GEG
        • Recruiting
        • Instituto De Investigaciones Clinicas Quilmes
      • San Fernando, Argentina, B1646GHP
        • Recruiting
        • MR Medicina Reumatologica
  • Brazil
      • Goiânia, Brazil, 74605-020
        • Recruiting
        • Hospital das Clinicas - UFG
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Brazil, 90480 000
        • Recruiting
        • LMK Servicos Medicos S S
      • Santo André, Brazil, 09060 870
        • Recruiting
        • Fundacao do ABC Centro Universitario FMABC
      • São José do Rio Preto, Brazil, 15090 000
        • Recruiting
        • Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
      • São Paulo, Brazil, 01232 010
        • Recruiting
        • ESHO Empresa De Servicos Hospitalares S A
  • China
      • Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
      • Linfen, China, 041000
        • Recruiting
        • Linfen Central Hospital
      • Ningbo, China, 315041
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
      • Shanwei, China, 516601
        • Recruiting
        • Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
      • Taiyuan, China, 030032
        • Recruiting
        • Shanxi Bethune Hospital
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel Medical Center
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Ein-Qarem Medical Center
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
      • Nahariya, Israel, 2210001
        • Recruiting
        • Galilee Medical Center
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
  • Japan
      • Isehara, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital
      • Naha, Japan, 900 0015
        • Recruiting
        • Shinkenko clinic
      • Tokyo, Japan, 104 8560
        • Recruiting
        • St. Luke's International Hospital
  • Malaysia
      • Johor Bahru, Malaysia, 81100
        • Recruiting
        • Hospital Sultan Ismail
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
      • Kuching, Malaysia, 93586
        • Recruiting
        • Hospital Umum Sarawak
      • Petaling Jaya, Malaysia, 47500
        • Recruiting
        • Sunway Medical Centre
      • Taiping, Malaysia, 34000
        • Recruiting
        • Hospital Taiping
  • Taiwan
      • Hsinchu, Taiwan, 302058
        • Recruiting
        • NTU Biomedical Park Hospital
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 813414
        • Recruiting
        • Kaohsiung Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Sehir Hastanesi
      • Ankara, Turkey (Türkiye), 06050
        • Recruiting
        • Ankara University Medical Faculty
      • Elâzığ, Turkey (Türkiye), 23200
        • Recruiting
        • Firat University Hospital
      • Gaziantep, Turkey (Türkiye), 27090
        • Recruiting
        • Sanko Universitesi Hastanesi
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Marmara University Istanbul Pendik Education and Research Hospital
      • Konya, Turkey (Türkiye), 42080
        • Recruiting
        • Necmettin Erbakan University Meram Medical Faculty
  • United Kingdom
      • Peterborough, United Kingdom, PE3 9GZ
        • Recruiting
        • Peterborough City Hospital
      • Southampton, United Kingdom, SO16 6HU
        • Recruiting
        • Southampton University Hospital
      • Stoke-on-Trent, United Kingdom, ST6 7AG
        • Recruiting
        • Haywood Hospital
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • David S Hallegua MD A Professional Corporation
      • Hemet, California, United States, 92543
        • Recruiting
        • Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
      • La Palma, California, United States, 90623
        • Recruiting
        • Advanced Medical Research
      • Tustin, California, United States, 92780
        • Recruiting
        • Solace Clinical Research California
      • Upland, California, United States, 91786
        • Recruiting
        • Inland Rheumatology Clinical Trials Inc.
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Arthritis & Rheumatic Disease Specialties
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida 1
      • Hialeah, Florida, United States, 33013
        • Recruiting
        • Avanti Clinical Research Corp
      • Miami, Florida, United States, 33126
        • Recruiting
        • LeJenue Research Associates PLLC
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Floridian Clinical Research LLC
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida
    • Illinois
      • Willowbrook, Illinois, United States, 60527
        • Recruiting
        • Willow Rheumatology and Wellness PLLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Recruiting
        • Accurate Clinical Research, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Joint and Muscle Research Institute
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • DJL Clinical Research, PLLC
      • Fayetteville, North Carolina, United States, 28304 4422
        • Recruiting
        • Cross Creek Medical Clinic
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research & Consulting
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Clinical Research Philadelphia
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • West Tennessee Research Institute
    • Texas
      • Allen, Texas, United States, 75013
        • Recruiting
        • Arthritis and Rheumatology Research Institute
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Center for Clinical Research
      • Katy, Texas, United States, 77449
        • Recruiting
        • R and H Clinical Research
      • Mesquite, Texas, United States, 75150
        • Recruiting
        • Southwest Rheumatology Research LLC
      • Plano, Texas, United States, 75024
        • Recruiting
        • Texas Rheumatology Research Institute LLC

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:-

  • Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening
  • Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (>=) 24 weeks prior to screening according to european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria
  • Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 and a clinical SLEDAI-2K >= 4 at screening, AND a clinical SLEDAI-2K score >= 4 points at Week 0, excluding points attributed to "lupus headache," "alopecia," and "organic brain syndrome"
  • Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization
  • Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening

Exclusion Criteria:

  • History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory
  • Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
  • Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
  • Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
  • Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation

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

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 Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52
Time Frame: 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]).
Week 52

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
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline IFN Gene Signature (Interferon [IFN] high)
Time Frame: Week 52
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.
Week 52
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with Sustained Reduction in Oral Glucocorticoid (GC) Dose
Time Frame: Week 52
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.
Week 52
Percentage of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) At Week 52
Time Frame: 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.
Week 52
Percentage of Participants with < 2 Active Joints at Week 52 in Participants with >= 2 Active Joints at Baseline
Time Frame: Week 52
Percentage of participants with < 2 active joints at Week 52 in participants with >= 2 active joints at baseline will be reported.
Week 52
Change From Baseline in Lupus Symptoms Joint Pain Score at Week 52
Time Frame: Baseline, Week 52
Lupus symptoms joint pain score at Week 52 will be reported.
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
Time Frame: 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 will be reported.
Week 52
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 52
Time Frame: Baseline, 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.
Baseline, Week 52
Percentage of Participants With BILAG Flare Free Status Through Week 52
Time Frame: Up to 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.
Up to Week 52
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline Autoantibodies (Autoantibody High)
Time Frame: Week 52
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.
Week 52

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

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.
March 5, 2026

Primary Completion (Estimated)

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.
December 6, 2028

Study Completion (Estimated)

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.
November 7, 2031

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).
February 23, 2026

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.
February 23, 2026

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.
February 27, 2026

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.
May 8, 2026

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.
May 7, 2026

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.
May 1, 2026

More Information

Terms related to this study

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.
  • 80202135SLE3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2025-523552-31-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

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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