A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients with Primary Sjögren’s Disease
Primary Sjögren’s disease is an autoimmune condition where the body’s defence system mistakenly attacks healthy glands that make saliva and tears. This often causes severe dryness, extreme tiredness, and joint pain. Currently, there are few targeted treatments available. This Phase 3 clinical trial is testing a new medicine called efgartigimod (brand name Vyvgart) against a dummy treatment (placebo). The medicine is given as an injection just under the skin using a pre-filled syringe. The study lasts for at least 48 weeks. Researchers want to find out whether the medicine is safe and if it successfully calms down inflammation, eases joint pain, and improves everyday quality of life. Later in the study, participants may have the option to receive the active medicine in an extended follow-up period.
At a glance
What is this study about?
Primary Sjögren’s disease is a long-term condition that affects moisture-producing glands in your body. People living with it frequently experience deeply uncomfortable dry eyes, a dry mouth, swollen joints, and ongoing fatigue. For many, everyday activities like speaking, eating, or working can become challenging. While current treatments can help soothe some symptoms, there are very few options that target the root cause of the disease.
This clinical trial focuses on a medicine called efgartigimod. In autoimmune conditions like Sjögren’s, the body produces rogue proteins called autoantibodies that attack healthy tissue. Efgartigimod is designed to help clear these harmful antibodies from your bloodstream, which may help reduce inflammation and relieve symptoms across your entire body.
This is a Phase 3 study, meaning the medicine has already shown promise in earlier, smaller studies. Researchers now want to confirm how well it works and monitor any side effects in a much larger group of people. Half of the participants will receive the active medicine and half will receive a harmless dummy injection (placebo) to ensure the results are reliable.
Taking part helps doctors understand whether this treatment could become a valuable new NHS option for people with Sjögren’s disease in the future.
Key takeaways
- Tests a new injection (efgartigimod) designed to lower harmful antibodies in Sjögren’s disease.
- Open to adults aged 18 and older with active primary Sjögren’s disease.
- The main trial phase lasts 48 weeks, with possible access to open-label treatment afterwards.
- Involves regular clinic visits for blood tests, joint checks, and dryness assessments.
- You can withdraw from the study at any time without losing any NHS care.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with primary Sjögren’s disease. To take part, your condition will usually need to be active, meaning you are currently experiencing symptoms such as joint pain, dryness, or general inflammation.
Both men and women can participate. However, people with certain other serious health issues, severe active infections, or those taking specific medications that alter the immune system might not be able to join.
If you are pregnant, planning a pregnancy, or breastfeeding, you will likely not be eligible for safety reasons. The study team at the trial centre will check your full medical history and carry out standard tests to make sure 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 aged 18 or older.
- I have a confirmed medical diagnosis of primary Sjögren’s disease.
- I have ongoing symptoms such as joint pain, fatigue, or dryness.
- I am able and willing to travel to regular hospital clinic appointments.
- I am not currently pregnant or breastfeeding.
What does participation involve?
If you join the trial, you will be placed into one of two groups by chance: one group receives efgartigimod injections, and the other receives a matching placebo dummy injection. The injections are given just under the skin with a pre-filled syringe. Neither you nor your study doctor will know which one you are receiving during the initial 48-week period. You will visit the clinic regularly for health checks, which include blood tests, symptom surveys, joint examinations, and tests to measure eye and mouth dryness. After this first phase, you may be offered the chance to enter an 'open-label' period, where everyone receives the real medicine.
Potential risks and benefits
Locations (18)
- —UnverifiedPoland
- —UnverifiedNetherlands
- —UnverifiedItaly
- —UnverifiedLithuania
- —UnverifiedRomania
- —UnverifiedAustria
- —UnverifiedGreece
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedSlovakia
- —UnverifiedFrance
- —UnverifiedEstonia
Common questions
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active ingredients. It helps doctors prove whether improvements or side effects are truly caused by the study medicine.
How is the study medicine taken?
It is given as an injection directly under the skin (subcutaneous injection) using a pre-filled syringe, similar to how insulin is given.
Will I have to pay for the study treatment?
No. The trial medicine, tests, and doctor visits are provided free of charge, and travel expenses are often reimbursed.
Can I continue seeing my regular GP or rheumatologist?
Yes. Your regular doctor will be kept informed, and you will continue your normal healthcare alongside the trial visits.
What happens after the first 48 weeks?
You may be invited to join an extension study where all participants receive the active medicine, giving everyone access to the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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