A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Participants with Sjogren’s Disease-Associated Sensorimotor or Sensory Polyneuropathy
Sjögren's disease is an autoimmune condition where the body's defence system mistakenly attacks healthy tissue. For some people, it can also cause nerve problems, leading to tingling, pain, numbness, or weakness in the arms and legs. This study looks at whether a medicine called Vyvgart (efgartigimod) can help treat this nerve damage. Participants will receive either the study medicine or a dummy injection (placebo) given under the skin using a pre-filled syringe. Neither you nor the study team will know which one you are receiving during the test period. Doctors will regularly check your nerve symptoms, fatigue levels, and general health to see if the treatment works and is safe. The results could help provide a new treatment option for people living with Sjögren's nerve pain.
At a glance
What is this study about?
Sjögren's disease is well known for causing dry eyes and a dry mouth, but it can affect the whole body. In some people, the immune system targets the nerves that control feeling and movement. This can lead to a condition called polyneuropathy, causing uncomfortable pins and needles, burning sensations, numbness, or muscle weakness in the hands and feet.
At present, treatments for nerve damage caused by Sjögren's are limited and do not work for everyone. Vyvgart is a medicine designed to lower specific antibodies in the blood that are thought to attack healthy nerves. By clearing these harmful antibodies, doctors hope the medicine can protect nerves and ease day-to-day symptoms.
This Phase 2 clinical trial is testing whether Vyvgart works better than an inactive treatment (a placebo) and whether it causes any unwanted side effects. Finding out if this medicine is safe and effective is an important step toward creating better care for people with this challenging condition.
Key takeaways
- Tests whether the medicine Vyvgart helps ease nerve damage linked to Sjögren's disease.
- Open to adults aged 18 and over with confirmed Sjögren's and nerve symptoms.
- Given as a simple injection under the skin using a pre-filled syringe.
- You have a chance of receiving a dummy treatment (placebo) instead of the active drug.
- Taking part is completely voluntary and you can leave at any point.
Who may be eligible?
This trial is open to men and women aged 18 and older who have been diagnosed with Sjögren's disease. You must also have symptoms of nerve damage in your hands, feet, or limbs, such as numbness, tingling, or weakness, that have been confirmed by a doctor.
To keep you safe, there are reasons why you might not be able to join. For example, people with other uncontrolled medical conditions, certain ongoing infections, or nerve damage caused by other illnesses (like diabetes) may not be suitable. A study doctor will review your full medical history to see if joining is safe for you.
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.
- I am at least 18 years old.
- I have a confirmed diagnosis of Sjögren's disease.
- I experience nerve problems such as numbness, tingling, burning pain, or weakness in my limbs.
- I am able and willing to attend regular hospital or clinic appointments for check-ups.
- I am comfortable receiving injections under the skin.
What does participation involve?
If you take part, you will have regular clinic visits. At the start, the study team will check your health using blood tests, heart checks (ECGs), and physical exams to make sure you are suitable. During the study, you will receive injections of either Vyvgart or a dummy drug just under the skin using a pre-filled syringe.
Throughout the study, you will complete short surveys about your nerve symptoms, tiredness, and quality of life. The doctors will also test the feeling and strength in your limbs. The study team will follow your progress closely across several months to monitor your response and check for any side effects.
Potential risks and benefits
Locations (13)
- —UnverifiedGermany
- —UnverifiedEstonia
- —UnverifiedLithuania
- —UnverifiedPortugal
- —UnverifiedSlovakia
- —UnverifiedHungary
- —UnverifiedRomania
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What is Vyvgart?
Vyvgart is a targeted medicine that reduces certain immune proteins in the blood. Doctors hope this stops the immune system from attacking healthy nerves.
Will I definitely receive the real medicine?
No. This is a double-blind study, meaning you have a fair chance of receiving either the active medicine or an inactive dummy injection (placebo).
How is the treatment given?
The treatment is given as an injection under the skin using a pre-filled syringe, similar to how insulin or some allergy medicines are given.
Do I have to pay to take part?
No, all study medicines, tests, and extra clinic appointments are free. Many trials also help cover your travel expenses to the clinic.
What happens if I want to stop?
You are free to leave the study at any time. Your normal medical care will continue as usual, and your doctor will help you choose your next steps.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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