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

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: Recruiting
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Placebo; Drug: Standard of care treatment; Drug: Nipocalimab

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52	SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLE Disease Activity Index 2000 (SLEDAI-2K), no British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as no new A or less than or equal to <= 1 new B items compared to baseline, no worsening in Physician's Global Assessment (PGA [greater than {>} 10 percent {%} increase from baseline]).	Week 52

Secondary Outcome Measures

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)	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	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	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	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	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	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	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	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)	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

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): December 6, 2028
• Study Completion (Estimated): November 7, 2031

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID 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