A study of nipocalimab in adults with moderate to severe systemic lupus erythematosus
| ISRCTN | ISRCTN15146958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15146958 |
| Clinical Trials Information System (CTIS) | 2025-523552-31 |
| Integrated Research Application System (IRAS) | 1013215 |
| Central Portfolio Management System (CPMS) | 70921 |
| Sponsor's protocol code number | 80202135SLE3001 |
| Sponsor | Janssen-Cilag International NV |
| Funder | Janssen Research and Development |
- Submission date
- 15/01/2026
- Registration date
- 13/03/2026
- Last edited
- 10/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Systemic lupus erythematosus (SLE) is a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs. SLE can often cause repeated kidney inflammation, which may lead to kidney failure. It can also result in serious health problems from treatments and, in some cases, death. Current treatments for SLE usually work by either managing the symptoms or suppressing the immune system. Therefore, there is a need for new treatment options that work better. Nipocalimab is a monoclonal antibody* that selectively blocks the immunoglobulin (IgG) binding site called the endogenous neonatal fragment crystallisable receptor (FcRN), resulting in a decrease of circulating IgG, thus reducing the inflammatory immune response to the harmful IgG in the body. *Type of protein designed to recognise and attach to a specific target. In this study, researchers want to learn how well nipocalimab works in participants with moderate to severe SLE as compared to placebo.
Who can participate?
Participants aged 18 years to 75 years with moderate to severe SLE.
What does the study involve?
The study consists of:
1. Screening period (up to Week 6)
2. Double-blind treatment period (Week 0 to Week 52): Participants will be randomly assigned to either Arm A (nipocalimab) or Arm B (placebo).
3. Open-label long-term extension period (Week 52 to Week 156): Eligible participants will have an option to enter an open-label long-term extension period and receive nipocalimab.
4. Safety follow-up (Week 162): Participants will be followed up for their health.
Safety assessments include monitoring of adverse events (AEs), serious AEs, and blood tests. All side effects will be recorded until the study ends (approximately 3 years and 1 month).
What are the possible benefits and risks of participating?
There is no established benefit to participants of this study. Based on scientific theory, taking nipocalimab may improve systemic lupus erythematosus (SLE). However, this cannot be guaranteed because nipocalimab is still under investigation as a treatment. Participants may experience some benefit from participation in the study that is not due to receiving the study drug but due to regular visits and assessments monitoring overall health. Participation may help other people with SLE in the future. In addition, all participants are allowed to continue standard-of-care background therapy.
Participants may have side effects from the drug or procedures used in this study that may be mild to severe and even life-threatening, and these can vary from person to person. The most common potential risks are getting side effects such as infections caused due to decreased serum IgG concentrations, reduced effectiveness of routine vaccines due to decreased IgG, activation of latent virus due to decreased IgG, hypoalbuminemia (low levels of albumin, a blood protein), injection site reactions, hypersensitivity (allergic reactions), drug-drug interactions and an increase in cholesterol after administering the study drug. There are other, less frequent potential risks. The participant information sheet and informed consent (which is signed by every participant) include a detailed section outlining the potential risks to participating in the study.
Not all possible side effects and risks related to the study drug are known at this moment. During the study, the sponsor may learn new information about the study drug. The study doctor will tell participants as soon as possible about any new information that might make them change their mind about being in the study, such as new risks. To minimise the risk associated with taking part in the study, participants are frequently reviewed for any side effects and other medical
events. Participants are educated to report any such events to their study doctor, who will provide appropriate medical care. Any serious side effects that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team. There are no costs to participants to be in the study. The sponsor will pay for the study drug and tests that are part of the study. The participant will receive reasonable reimbursement for study-related costs (e.g., travel/parking costs).
Where is the study run from?
Janssen-Cilag International NV (Netherlands)
When is the study starting and how long is it expected to run for?
March 2026 to February 2031
Who is funding the study?
Janssen-Cilag International NV (Netherlands)
Who is the main contact?
JanssenUKRegistryQueries@its.jnj.com
Contact information
Scientific
50-100 Holmers Farm Way
High Wycombe
HP12 4DP
United Kingdom
| Phone | +44 (0)800 731 8450 |
|---|---|
| JanssenUKRegistryQueries@its.jnj.com |
Principal investigator
Southampton General Hospital, Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Treatment, Safety |
| Scientific title | A Phase III, randomised, double-blind, placebo-controlled, multicentre study of nipocalimab in adults with moderate to severe systemic lupus erythematosus |
| Study acronym | GARDENIA |
| Study objectives | Primary objective: To evaluate how well nipocalimab works in participants with moderate to severe Systemic Lupus Erythematosus (SLE) as compared to placebo. Secondary objective: To further evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe SLE. |
| Ethics approval(s) |
Approved 05/03/2026, West of Scotland REC 1 (West of Scotland Research Ethics Service, Admin Building, Level 2, Gartnavel Royal Hospital, 1055 Great Western Road, Glasgow, G12 0XH, United Kingdom; -; ggc.wosrec1@nhs.scot), ref: 26/WS/0012 |
| Health condition(s) or problem(s) studied | Systemic lupus erythematosus |
| Intervention | 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 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. Placebo Comparator: Placebo Participants will receive a placebo up to Week 52 in the double-blind treatment period along with standard of care treatment. At Week 52, eligible participants will have the option to enter an open-label extension period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Nipocalimab |
| Primary outcome measure(s) |
Percentage of participants achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 composite |
| Key secondary outcome measure(s) |
1. Percentage of participants achieving an SLE SRI-4 composite response at Week 52 with a high baseline IFN gene signature (‘Interferon [IFN] high’). The 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 or fewer new B items compared to baseline and no worsening in PGA (more than 10% increase from baseline). ‘IFN high’ is defined as an elevated peripheral type 1 IFN gene signature at baseline. |
| Completion date | 21/02/2031 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 600 |
| Key inclusion criteria | 1. Aged 18 to 75 years old 2. Male or female 3. Medically stable on the basis of physical examination, medical history, vital signs and a 12-lead electrocardiogram (ECG) performed at screening 4. A clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to 24 weeks before screening. This diagnosis should be made according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria. 5. Participants must have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to 6 and a Clinical SLEDAI-2K greater than or equal to 4 at screening, AND a clinical SLEDAI-2K score greater than or equal to 4 points at Week 0, excluding points attributed to “lupus headache,” “alopecia,” and “organic brain syndrome”. 6. 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 before randomisation 7. Participants must have at least one BILAG#2004 (British Isles Lupus Assessment Group#2004) A score or two BILAG#2004 B scores observed at screening |
| Key exclusion criteria | 1. 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 tests 2. Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications 3. 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 4. Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins 5. Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation |
| Date of first enrolment | 06/03/2026 |
| Date of final enrolment | 27/10/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Argentina
- Australia
- Brazil
- Bulgaria
- China
- Colombia
- Czech Republic
- Denmark
- Finland
- France
- Georgia
- Germany
- Greece
- Hungary
- Israel
- Italy
- Japan
- Korea, South
- Malaysia
- Mexico
- Norway
- Poland
- Portugal
- Romania
- Serbia
- Slovakia
- South Africa
- Spain
- Switzerland
- Taiwan
- Thailand
- Türkiye
- United States of America
Study participating centres
Bretton Gate
Bretton
Peterborough
PE3 9GZ
England
Marlborough Road
Swindon
SN3 6BB
England
London
SE1 9RT
England
Tremona Road
Southampton
SO16 6YD
England
Stoke-on-trent
ST6 7AG
England
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Bath
BA1 3NG
England
Cambridge
CB2 0QQ
England
Reading
RG1 5AN
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinicaltrials/transparency. As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access (YODA) Project site at yoda.yale.edu. |
Editorial Notes
10/04/2026: Internal review.
06/03/2026: ISRCTN received notification of combined HRA/MHRA approval for this trial on 06/03/2026.
15/01/2026: Study's existence confirmed by the HRA.
