AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, placebo-controlled, multicenter Phase 2a/b study assessing the efficacy, safety and tolerability of DDY391 in participants with Sjögren's Disease

Sjögren's disease is an autoimmune condition where the body's immune system mistakenly attacks its own moisture-producing glands. This often leads to very dry eyes and mouth, joint pain, and profound fatigue. Right now, there is no cure, and current treatments mainly focus on soothing symptoms. This study tests an experimental drug called DDY391 to find out if it is safe and effective at reducing disease activity. It is a 'double-blind' trial, which means neither you nor the study team will know whether you are taking the active medicine or a placebo (a dummy treatment). Doctors will measure your symptom changes at 24 weeks and continue tracking your overall health and safety for up to 52 weeks (one year). The main goal is to find out if DDY391 can improve daily quality of life and lower inflammation throughout the body.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

Start

15 Oct 2026

Sjögren's Disease

What is this study about?

Sjögren's disease is a long-term condition that causes the immune system to attack healthy parts of the body, particularly the glands that make saliva and tears. People living with Sjögren's often struggle with painful dry eyes, a very dry mouth, extreme tiredness, and aching joints. Because current treatments often only mask the symptoms rather than calm the immune system down, there is a strong need for new, targeted therapies.

This Phase 2 trial is investigating a new drug called DDY391. Researchers want to understand whether this treatment can safely dampen the harmful immune activity that causes Sjögren's symptoms. The trial is comparing DDY391 to a placebo, which looks identical but contains no active medicine. Comparing the new drug against a placebo helps scientists be sure that any health improvements are genuinely caused by DDY391.

During the study, doctors will track your progress using standardised medical checklists, such as the ESSDAI (which measures disease activity across organs) and the ESSPRI (which measures how you feel regarding pain, dryness, and fatigue). They will also ask you to fill in regular symptom diaries. If successful, this research could pave the way for a much-needed treatment option that tackles the underlying disease rather than just its symptoms.

Key takeaways

Phase 2 clinical trial testing an experimental drug (DDY391) for Sjögren's disease.
Compares the study drug to a dummy pill (placebo) to test its safety and effectiveness.
Aimed at adults aged 18 and older with an active diagnosis of Sjögren's disease.
Involves regular clinic check-ups, blood tests, and symptom diaries over up to 52 weeks.
Participation is completely voluntary and you can leave the study at any time.

Who may be eligible?

This trial is open to adults aged 18 and over who have a confirmed medical diagnosis of Sjögren's disease. Doctors are looking for participants who have active symptoms, such as noticeable dryness, pain, or tiredness, as this helps show whether the study drug makes a real difference.

Because your safety is the top priority, you may not be able to take part if you have certain other major medical conditions, active infections, or if you take specific medications that could clash with the study drug.

Pregnant or breastfeeding women are typically excluded from this type of trial to protect the baby. A study doctor will review your full medical history and current treatments to confirm whether this trial is safe and suitable 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 been diagnosed with Sjögren's disease by a doctor.
I am currently experiencing symptoms like dry eyes, dry mouth, or joint pain.
I am willing and able to travel to a trial centre for regular appointments over 12 months.
I am happy to keep a regular symptom diary and complete health questionnaires.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for up to 52 weeks (about one year). During this time, you will be randomly assigned by a computer to receive either the study drug (DDY391) or a dummy treatment (placebo).

You will need to attend regular appointments at a study clinic. At these visits, doctors and nurses will check your vital signs, perform physical examinations, and take routine blood and urine samples. You will also be asked to complete questionnaires and keep a daily symptom diary on an electronic device to track how dry, tired, or uncomfortable you feel.

The most intensive checks take place over the first 24 weeks to see how your symptoms respond. After this, your health will continue to be monitored closely through to week 52 to make sure the treatment remains safe.

Potential risks and benefits

You may experience improvements in your Sjögren's symptoms if you receive DDY391, but there is no guarantee it will work, and you might receive the placebo instead. Like all new medicines, DDY391 carries risks of side effects, which the medical team will explain in detail before you start. You will receive close medical monitoring throughout the trial at no cost to you. Taking part is completely voluntary, and you can withdraw from the study at any time without giving a reason and without your usual NHS care being affected.

Locations (6)

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

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Unverified
Portugal
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Unverified
Belgium
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Unverified
Denmark
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Unverified
France
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Unverified
Italy
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Unverified
Netherlands

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 researchers see whether changes in health are genuinely caused by the study drug or happen by chance.

Can I choose to get DDY391 instead of the placebo?

No. A computer randomly decides who receives the study medicine and who receives the placebo. Neither you nor your study doctor can choose your group.

Can I continue taking my regular Sjögren's treatments?

Some everyday treatments like artificial tears or saliva sprays are usually allowed, but certain immune-suppressing medicines might need to be paused. The study doctor will check all your medications.

Will taking part cost me anything?

No. The study medication, clinic visits, and medical tests are provided free of charge. Most trials also reimburse reasonable travel and parking expenses.

What happens if I want to leave the study early?

You are free to leave the trial at any time. Your decision will not change your relationship with your doctors or alter the standard of care you normally receive.