Active not recruitingPHASE3INTERVENTIONAL

Nipocalimab in Moderate to Severe Sjogren's Disease

This research study is looking at a new treatment called nipocalimab for people living with Sjögren's disease, specifically those with moderate to severe symptoms. The main goal is to find out if this new drug can help manage the condition and if it's safe to use. Participants will receive either nipocalimab, a placebo (a treatment with no active drug), or their usual care. This is a "Phase 3" study, meaning it's one of the final steps before a new drug might be approved for wider use. Researchers are conducting two identical studies to thoroughly check the drug's effects across different groups of people aged 18 and over.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

655

Start

04 Dec 2024

Estimated completion

18 May 2029

Sjogrens Syndrome

What is this study about?

This study is investigating a new medication called nipocalimab for individuals who have been diagnosed with Sjögren's disease, particularly when their symptoms are moderate to severe. Sjögren's disease is a long-term (chronic) condition that primarily affects the moisture-producing glands, leading to symptoms like dry eyes and dry mouth, but it can also affect other parts of the body.

The researchers want to understand if nipocalimab can improve the health and well-being of people with Sjögren's disease. They will compare its effects against a 'placebo' – which looks like the study drug but doesn't contain any active medicine – and patients' existing treatments. This helps the researchers determine if any changes are truly due to nipocalimab or other factors.

This kind of study, known as "Phase 3," means that nipocalimab has already undergone earlier testing and shown some promise. It's a crucial step in the drug development process to gather comprehensive information about its effectiveness and safety before it could potentially be made available to more people.

Key takeaways

Tests a new drug called nipocalimab for Sjögren's disease.
Aimed at people with moderate to severe Sjögren's.
Compares nipocalimab to a dummy treatment (placebo).
Focuses on safety and how well the treatment works.
Participation is voluntary and closely monitored.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of Sjögren's disease. Your disease should be considered moderate to severe, meaning your symptoms are significantly affecting your daily life. You'll also need to have specific markers in your blood, known as Ro/SSA antibodies, which are common in Sjögren's disease.

There are also some health check-ups to make sure you're generally well enough to take part. This includes having stable health based on a physical exam, medical history, blood tests, and an electrocardiogram (ECG) which checks your heart.

You wouldn't be able to join if you have other serious health conditions, such as severe heart, lung, kidney, or liver problems. Also, if you have a known allergy to nipocalimab or similar medications, or if your Sjögren's disease is rapidly worsening and requires immediate changes to your current treatment, you wouldn't be suitable for this study.

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 18 years old or older?
Do you have a diagnosis of Sjögren's disease?
Are your Sjögren's symptoms moderate to severe?
Have you been told you have Ro/SSA antibodies in your blood?
Are you generally in stable health without other serious medical conditions?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you will have regular visits to the clinic for health check-ups, assessments of your Sjögren's symptoms, and to receive your study medication (either nipocalimab or placebo). You will continue with your usual Sjögren's disease treatments throughout the study unless otherwise advised by the study team. The total duration of your participation in the study will be shared by the study team, and it involves regular follow-up to monitor your health and how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new experimental treatment that might improve your condition. However, there are also potential risks, including side effects from the study medication or the possibility that the treatment may not work for you. All medical procedures and medications carry some risks. Your health and safety will be closely monitored throughout the study. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (254)

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

Advanced Clinical Research Center
Verified postcode
Chula Vista, United States
Providence Medical Foundation
Verified postcode
Fullerton, United States
Arthritis & Osteoporosis Medical Center - La Palma
Verified postcode
La Palma, United States
NovaMed Research
Verified postcode
Monterey Park, United States
Medvin Clinical Research San Leandro
Verified postcode
San Leandro, United States
Providence Saint John s Health Center
Verified postcode
Santa Monica, United States
Solace Clinical Research California
Verified postcode
Tustin, United States
Inland Rheumatology Clinical Trials Inc.
Verified postcode
Upland, United States
Denver Arthritis Clinic
Verified postcode
Denver, United States
Clinical Research of West Florida Inc
Verified postcode
Clearwater, United States
UF Health Rheumatology
Verified postcode
Jacksonville, United States
Suncoast Clinical Research
Verified postcode
New Port Richey, United States

Common questions

What is Sjögren's disease?

It's a long-term condition that causes the body's immune system to attack glands that produce moisture, like those for tears and saliva, leading to dryness in the eyes and mouth, and can also affect other organs.

What is a 'placebo'?

A placebo is adummy treatment that looks identical to the study drug but contains no active medicine. It helps researchers see if the real drug is truly effective.

What does 'Phase 3' mean for a drug study?

Phase 3 is an advanced stage of testing where a new treatment is studied in a larger group of people to confirm its effectiveness, monitor side effects, compare it to common treatments, and collect information that will allow the drug to be used safely.

Will I know if I'm getting the drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving nipocalimab or the placebo. This helps ensure the study results are unbiased.

What are 'Ro/SSA antibodies'?

These are specific proteins found in the blood that are commonly present in people with Sjögren's disease. Having them helps confirm your diagnosis for this study.