Not recruiting

A Study Testing Imeroprubart for Adults with Primary Sjogren's Disease with Moderate to Severe Symptoms

Fast replyInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with Primary Sjogren's Disease, a condition where the body's immune system attacks its own moisture-producing glands, leading to dryness of the eyes and mouth, as well as other symptoms throughout the body. The disease can also affect other organs and cause fatigue and joint pain. The study will test a medication called IMVT-1402, which is given as an injection under the skin, and compare it to placebo. The purpose of this study is to find out how well IMVT-1402 works in reducing the activity of the disease in people who have moderate to severe symptoms affecting various parts of the body.

The study will look at whether IMVT-1402 can help improve the overall disease activity by measuring changes in a scoring system that tracks how different body systems are affected by the disease. Participants will receive either IMVT-1402 or placebo through injections under the skin once a week. The main part of the study will last for 24 weeks, during which doctors will monitor how the disease activity changes from the beginning of the study. The total treatment period can last up to 48 weeks.

People taking part in this study will need to have been diagnosed with Primary Sjogren's Disease for at least 12 months and have a certain level of disease activity affecting their body systems. They will also need to have specific antibodies in their blood that are commonly found in people with this condition, and they must still have some ability to produce saliva. Throughout the study, participants will have regular visits to check their symptoms and how well the treatment is working.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period begins
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive IMVT-1402, which contains the active substance imeroprubart. The other group will receive a placebo, which looks identical but contains no active substance.
You will not know which treatment you are receiving, and neither will your study doctor. This is called a double-blind study design.
Step 2
Receiving injections
You will receive injections under the skin (subcutaneous injections) once every week.
The medication is provided as a solution for injection.
This treatment schedule will continue throughout the study period.
Step 3
Assessment at week 24
At week 24 of the treatment, your disease activity will be assessed using a scoring system called clinESSDAI.
The clinESSDAI score measures the activity of your condition across different body systems. The change in this score from the beginning of the study will be compared to your score at week 24.
This assessment is the main measure used to determine how well the treatment is working.
Step 4
Completion of the study
The study will continue until all planned assessments are completed.
Throughout the study period, your safety and how well you tolerate the treatment will be monitored.
The study is expected to be completed by February 2028.

Who can join the trial?

6 criteria

You must have a diagnosis of primary Sjögren's Disease, which is a condition where your immune system attacks glands that produce moisture, for at least 12 months before joining the study
You must meet the standard medical criteria for primary Sjögren's Disease according to guidelines established in 2016
You must have moderate to severe disease activity, measured by a score of at least 5 on a scale called clinESSDAI, which assesses how active your disease is across different body systems
You must test positive for SSA/Ro antibodies, which are specific proteins in your blood that indicate your immune system is attacking certain parts of your body
You must still have some saliva production, measured as at least 0.01 milliliters per minute when your saliva glands are stimulated during testing
You can be male or female to participate in this study

Who cannot join the trial?

3 criteria

The specific exclusion criteria (reasons why a patient cannot participate in the study) have not been provided in the available information for this clinical trial
Patients interested in this study should discuss with their doctor whether they meet the requirements to participate
The doctor will review the complete list of conditions and situations that would prevent participation in this research

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Verified
Palermo, Italy
Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Spitalul Clinic Judetean De Urgenta Cluj
Responsive
Cluj Napoca, Romania

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

IMVT-1402 is an investigational medication being tested in this clinical trial. It is given as an injection under the skin once a week. This medication is being studied to see if it can help reduce disease activity in people with primary Sjogren's disease, which is a condition that affects the body's moisture-producing glands and can cause various symptoms throughout the body. The study will compare how well this medication works against a placebo to determine if it is effective and safe for treating moderate to severe forms of this disease.

IMEROPRUBART

What is already known about the treatment

IMVT-1402 – IMVT-1402 is an investigational medication currently being studied in clinical trials and is not yet approved for general medical use. It is administered as a subcutaneous injection, which means it is given as a shot under the skin once weekly. This medication is being tested for the treatment of Primary Sjogren's Disease, an autoimmune condition where the body's immune system attacks moisture-producing glands, causing dry eyes and mouth along with other symptoms affecting various body systems. The specific way IMVT-1402 works at the molecular level has not been disclosed in the available trial information, but it is being evaluated for its ability to reduce moderate to severe systemic disease activity in adults with this condition.

Investigated diseases

Primary Sjögren's Disease – Primary Sjögren's Disease is a chronic autoimmune disorder where the body's immune system mistakenly attacks its own moisture-producing glands. The condition primarily affects the salivary glands in the mouth and the lacrimal glands in the eyes, leading to reduced production of saliva and tears. Patients commonly experience persistent dry mouth and dry eyes as the main symptoms. As the disease progresses, it can also affect other parts of the body, including joints, skin, and internal organs. The inflammation caused by the immune system gradually damages the glands over time. This condition occurs independently without being associated with other autoimmune diseases.