RecruitingPHASE3INTERVENTIONAL

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

This research study is investigating a new medication called nipocalimab for adults who have moderate to severe Systemic Lupus Erythematosus (SLE), often just called lupus. Lupus is a long-term condition where your immune system mistakenly attacks healthy parts of your body, causing inflammation and redness in various organs. The main goal of this study is to find out how effective nipocalimab is compared to a placebo (a treatment with no active medicine) in managing lupus symptoms and disease activity. Participants will also continue their standard lupus treatments. It's a Phase 3 study, meaning it's a later stage of research that tests the treatment in a larger group of people to confirm its effectiveness and monitor for side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

600

Start

05 Mar 2026

Estimated completion

07 Nov 2031

Lupus Erythematosus, Systemic

What is this study about?

This study is investigating a new treatment called nipocalimab for a condition known as Systemic Lupus Erythematosus, or lupus. Lupus is an autoimmune disease, which means your body's immune system, which normally fights off infections, starts attacking your own healthy tissues instead. This can lead to swelling, pain, and damage in various parts of the body, including joints, skin, kidneys, and other organs.

The main purpose of this study is to see if nipocalimab can help people with moderate to severe lupus. Researchers want to compare its effects against a placebo, which is a treatment that looks identical but contains no active medicine. This comparison helps them understand if any improvements seen are due to the new medicine or other factors. All participants will also continue to receive their usual lupus care.

By taking part, you would be helping doctors and scientists better understand lupus and potentially find new ways to manage it. This kind of research is crucial for developing better treatments for chronic conditions like lupus, aiming to improve the quality of life for those affected.

Key takeaways

New medicine (nipocalimab) for moderate to severe lupus being tested.
Compares nipocalimab against a dummy treatment (placebo).
Participants continue their usual lupus care.
For adults aged 18-75 with an existing lupus diagnosis.
Involves regular clinic visits for health checks and monitoring.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 75 years old and have a confirmed diagnosis of lupus for at least 24 weeks (about six months) before the study starts. Your lupus symptoms need to be currently active and considered moderate to severe by the study doctors. You should also be generally stable and healthy otherwise, based on a medical check-up, medical history, and heart test (ECG).

There are also certain conditions that would prevent you from taking part. For example, if you have severe, uncontrolled, or rapidly worsening problems with your liver, kidneys, heart, or other major organs, or other serious health issues. You also couldn't join if you have a known problem with your immune system not related to lupus, or a history of severe allergic reactions to medicines similar to nipocalimab or its ingredients. If your lupus is currently unstable and likely needs immediate changes to your usual treatment, you wouldn't be able to participate either.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Have you been diagnosed with lupus for at least 6 months?
Do you currently have moderate to severe lupus symptoms?
Are you generally stable and healthy, aside from your lupus?
Do you NOT have a severe, uncontrolled health problem affecting your liver, heart, or other major organs?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study medicine (nipocalimab) or a placebo, in addition to your current lupus treatments. You would have regular visits to the clinic for medical examinations, blood tests, and to discuss how you're feeling. These visits help the study team monitor your health, how your lupus is responding, and check for any side effects.

The total duration of your participation in the study is not specified in detail here, but these types of studies typically involve multiple study visits over several months to over a year. You would be given a detailed schedule of visits and what to expect at each appointment before you agree to join. All study medicines and care directly related to the research will be provided by the study team.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, such as gaining access to a new experimental treatment that isn't yet widely available, and receiving close medical monitoring during the study. However, there's no guarantee that the treatment will be effective for you, or that you'll receive the active drug rather than the placebo. Potential risks could include experiencing side effects from the study medication, which will be thoroughly explained to you, or requiring additional clinic visits. It’s important to remember that all participants have the right to withdraw from the study at any time, for any reason, without affecting their standard medical care.

Locations (69)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

David S Hallegua MD A Professional Corporation
Verified postcode
Beverly Hills, United States· Recruiting
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
Verified postcode
Hemet, United States· Recruiting
Advanced Medical Research
Verified postcode
La Palma, United States· Recruiting
Solace Clinical Research California
Verified postcode
Tustin, United States· Recruiting
Inland Rheumatology Clinical Trials Inc.
Verified postcode
Upland, United States· Recruiting
Arthritis & Rheumatic Disease Specialties
Verified postcode
Aventura, United States· Recruiting
Clinical Research of West Florida 1
Verified postcode
Clearwater, United States· Recruiting
Avanti Clinical Research Corp
Verified postcode
Hialeah, United States· Recruiting
LeJenue Research Associates PLLC
Verified postcode
Miami, United States· Recruiting
Floridian Clinical Research LLC
Verified postcode
Miami Lakes, United States· Recruiting
Clinical Research of West Florida
Verified postcode
Tampa, United States· Recruiting
Willow Rheumatology and Wellness PLLC
Verified postcode
Willowbrook, United States· Recruiting

Common questions

What is lupus (Systemic Lupus Erythematosus)?

Lupus is a long-term condition where your immune system mistakenly attacks healthy parts of your own body, causing inflammation and damage to various organs and tissues.

What is nipocalimab?

Nipocalimab is an experimental medicine being tested in this study to see if it can help manage moderate to severe lupus symptoms.

What is a placebo?

A placebo is a treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the active medicine.

Will I still take my regular lupus medicines?

Yes, participants in this study will continue to receive their standard lupus treatments alongside either nipocalimab or the placebo.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect your usual medical care.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.