AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants with Active Primary Sjögren’s Disease

Primary Sjögren's disease is an ongoing autoimmune condition that causes dry eyes, a dry mouth, joint pain, and profound fatigue. This Phase 3 clinical trial is investigating whether a new injection called telitacicept can help adults with active Sjögren's disease feel better and reduce body-wide inflammation. Participants will be placed at random into one of two groups. One group receives the active study drug, telitacicept, while the other receives an inactive dummy injection (placebo). Neither you nor your research team will know which one you receive. The trial lasts around 48 weeks, during which doctors will check your tear and saliva production, monitor your overall health through routine checks, and see if your everyday symptoms improve. Taking part helps doctors understand if this medicine is safe and effective enough to become a future treatment option.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Vor Biopharma Inc.

Enrolment target

Start

06 Oct 2026

Active Primary Sjögren’s Disease

What is this study about?

Sjögren's disease is a condition where the body's immune system mistakenly attacks its own healthy glands, particularly the ones that produce tears and spit. This often leads to uncomfortable dry eyes, dry mouth, long-lasting tiredness, and aching joints. Currently, treatments mostly focus on relieving symptoms—such as using artificial tears—rather than tackling the underlying inflammation. Finding new medicines that target the source of the problem is essential for improving long-term health.

This trial is testing an experimental injection called telitacicept. The medicine is designed to calm down specific immune cells that cause inflammation in Sjögren's disease. Researchers want to find out whether telitacicept can successfully reduce overall disease activity and improve common, frustrating problems like dryness and extreme fatigue over a 48-week period.

Because this is a Phase 3 study, it is one of the final stages of testing before a new medicine can be approved for general use. By comparing telitacicept to a placebo (an injection with no active drug), doctors can clearly see whether any health improvements are truly caused by the new treatment and whether it is safe for regular use.

Key takeaways

Tests a new medicine, telitacicept, to see if it reduces inflammation from primary Sjögren's disease.
Open to adults aged 18 and older with active symptoms.
Compares the active drug against an inactive dummy injection (placebo) over 48 weeks.
Involves regular clinic visits to track tear levels, saliva flow, fatigue, and general health.
Taking part is voluntary, and you can withdraw at any time without losing normal medical support.

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with active primary Sjögren's disease. 'Primary' means the condition does not stem from another autoimmune illness, such as lupus or rheumatoid arthritis. 'Active' means your symptoms are currently causing noticeable inflammation or discomfort that needs medical care.

Both men and women may join the study. However, the trial team will need to carry out health assessments before you start to ensure it is completely safe for you to take part. For instance, people with certain other severe long-term medical conditions, recent major infections, or those taking specific medicines that could clash with the study drug may not be able to participate.

If you are interested in joining, the study doctor will go through your complete medical background and discuss whether you meet all the necessary safety requirements.

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 an official diagnosis of primary Sjögren's disease.
My Sjögren's symptoms are currently active and causing issues.
I am willing and able to attend clinic appointments for around 48 weeks.
I am comfortable receiving injections as part of my medical care.

Answer every question to see your result.

What does participation involve?

Taking part in this trial involves receiving regular injections of either telitacicept or a placebo over a 48-week period. You will need to attend regular appointments at a hospital or clinical trial clinic. During these visits, doctors will monitor your health closely using standard blood and urine tests, blood pressure checks, and physical examinations. They will also measure how much saliva and tears you produce using gentle, non-invasive tests, such as placing a tiny paper strip near your eyelid to check tear levels. You will be asked to fill out simple questionnaires about your fatigue, pain, and how Sjögren's affects your everyday quality of life throughout the study.

Potential risks and benefits

Taking part in this study may help improve your Sjögren's symptoms, and your feedback will help researchers develop better treatments for others in the future. However, there is no guarantee you will personally benefit, especially if you receive the placebo injection. Like all medicines that affect the immune system, telitacicept carries potential risks, including mild reactions where the needle goes in, headaches, or a slightly higher chance of catching everyday infections like colds. Your safety will be tracked closely throughout the trial, and you are entirely free to leave the study at any time without it affecting your usual NHS medical care.

Locations (10)

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

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Unverified
Poland
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Unverified
Spain
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Unverified
Hungary
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Unverified
Italy
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Unverified
Netherlands
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Unverified
Romania
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Unverified
Belgium
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Unverified
France
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Unverified
Bulgaria
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Unverified
Germany

Common questions

What is a Phase 3 clinical trial?

A Phase 3 trial tests a new treatment in a large group of people to confirm how well it works, check for side effects, and compare it against standard treatments or a placebo before it can be approved.

What is a placebo and why is it used?

A placebo looks just like the real medicine but contains no active ingredients. It helps researchers know whether improvements or side effects are genuinely caused by the medicine being tested.

Can I choose whether I get the real drug or the placebo?

No. A computer assigns participants by chance, like flipping a coin. Neither you nor your trial doctor can choose or know which group you are in during the trial.

Will taking part cost me anything?

No. The study medication, clinic visits, and all trial tests are free. Many trials also help cover reasonable travel expenses to and from the clinic.

Can I leave the study if I change my mind?

Yes. Joining is entirely voluntary. You can stop taking part at any time, for any reason, and your regular doctor will continue to provide your usual care.