Not recruitingRare disease

Study on the Effects of Abiprubart for Patients with Sjögren’s Disease

Verified siteInvestigational

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 clinical trial is focused on studying Sjögren’s Disease, a condition that affects the body's moisture-producing glands, leading to symptoms like dry mouth and eyes. The trial will evaluate a treatment called Abiprubart, which is being tested to see how well it works and how safe it is for people with this disease. Participants in the study will receive either the treatment or a placebo, which is a substance with no active medication.

The purpose of the study is to assess the effect of Abiprubart on the activity of Sjögren’s Disease. The study will take place over several weeks, during which participants will receive doses of the treatment through injections. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their symptoms. The study aims to gather information on how Abiprubart affects the disease and to identify any potential side effects. This information will help determine if Abiprubart could be a beneficial treatment option for people with Sjögren’s Disease in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, the participant will attend an initial visit. During this visit, the participant will undergo a series of assessments to confirm eligibility for the trial. This includes a review of medical history, a physical examination, and laboratory tests.
The participant will also be informed about the study procedures, potential risks, and benefits. Informed consent will be obtained, ensuring the participant understands and agrees to comply with the study requirements.
Step 2
Randomization
After eligibility is confirmed, the participant will be randomly assigned to receive either the study medication, abiprubart, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.
The purpose of randomization is to ensure that the study results are unbiased and reliable.
Step 3
Treatment phase
During the treatment phase, the participant will receive the assigned treatment through subcutaneous injection. The exact dosage and frequency will be determined by the study protocol and communicated to the participant.
The treatment phase will last for a specified duration, during which the participant will attend regular study visits for monitoring and assessment.
Step 4
Follow-up visits
Throughout the study, the participant will attend follow-up visits at the study site. These visits are scheduled at regular intervals to monitor the participant's health and response to the treatment.
Assessments may include physical examinations, laboratory tests, and questionnaires to evaluate symptoms and quality of life.
Step 5
End of study visit
At the end of the study, the participant will attend a final visit. This visit will include a comprehensive assessment to evaluate the overall impact of the treatment.
The participant will be informed about the next steps and any additional follow-up that may be required.

Who can join the trial?

12 criteria

The person must be able to understand the study information, agree to participate, and follow the study rules.
The person must be between 18 and 80 years old.
The person must have a diagnosis of Sjögren’s Disease based on specific medical criteria.
The person must have a certain level of disease activity, measured by a score called ESSDAI, which should be 5 or higher. This score looks at different body systems affected by the disease.
The person must test positive for specific antibodies called anti-SSA antibodies in a blood test.
The person must have a saliva flow rate of at least 0.05 mL per minute during screening.
The person must weigh between 40 kg and 150 kg and have a body mass index (BMI) between 18 and 40.
The person should be up to date with routine adult vaccinations, including COVID-19, flu, pneumonia, and shingles, based on their medical history and risk factors.
If the person is female, she must be either postmenopausal, surgically sterile, or use effective birth control if she can have children. She must not be pregnant or breastfeeding.
Sexually active male participants must have had a vasectomy or agree to use a condom or effective birth control with partners who can have children.
Male participants must agree not to donate sperm during the study and for 30 days after the last dose of the study drug. Female participants must agree not to donate eggs during the study.
Females who can have children must have a negative pregnancy test before starting the study and on the first day of the study.

Who cannot join the trial?

10 criteria

Patients with any other **autoimmune diseases** besides Sjögren’s Disease. (Autoimmune diseases are conditions where the body's immune system attacks its own tissues.)
Patients who have had a **serious infection** in the past 3 months. (A serious infection is one that requires hospitalization or intravenous antibiotics.)
Patients who have been diagnosed with **cancer** in the past 5 years, except for certain types of skin cancer that have been treated.
Patients who are currently pregnant or breastfeeding.
Patients who have a history of **substance abuse** in the past year. (Substance abuse refers to the harmful use of substances like drugs or alcohol.)
Patients who have received any **live vaccines** in the past 4 weeks. (Live vaccines contain a small amount of the living virus or bacteria.)
Patients who are currently participating in another clinical trial.
Patients with **severe heart, liver, or kidney disease**. (These are serious conditions affecting the heart, liver, or kidneys.)
Patients who have had an **organ transplant**. (An organ transplant is a surgical operation where a failing or damaged organ is replaced with a healthy one.)
Patients with **uncontrolled high blood pressure**. (High blood pressure is when the force of the blood against the artery walls is too high.)

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

Centre Hospitalier Regional Et Universitaire De Brest
Verified
Brest, France
Centre Hospitalier Universitaire De Lille
Verified
Lille, France
Centre Hospitalier Universitaire d’Orléans
Verified
Orléans, France

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

Abiprubart is a medication being studied for its potential to help people with Sjögren’s Disease, a condition where the body's immune system attacks its own moisture-producing glands. This medication is being tested to see if it can reduce the activity of the disease, which means it might help lessen the symptoms and improve the quality of life for those affected. The study is designed to understand how effective and safe Abiprubart is for treating this condition.

Kpl-404

What is already known about the treatment

Abiprubart – Abiprubart is administered in a form that is suitable for clinical trials, typically involving injections or oral tablets, though the exact form in this trial is not specified. It is currently being studied in a Phase 2 clinical trial to assess its effectiveness and safety for treating Sjögren’s Disease, an autoimmune condition. The main therapeutic indication for Abiprubart is to reduce the activity of Sjögren’s Disease, which affects moisture-producing glands. At the molecular level, Abiprubart works by modulating the immune system to decrease inflammation and immune response, though specific details of its mechanism are still under investigation. It is classified pharmacologically as an immunomodulatory agent, which means it helps regulate or normalize the immune system.

Investigated diseases

Sjögren’s Syndrome – Sjögren’s Syndrome is an autoimmune disorder characterized by the body's immune system mistakenly attacking its own moisture-producing glands. This leads to symptoms such as dry mouth and dry eyes. Over time, the disease can cause inflammation and damage to other parts of the body, including joints, skin, and internal organs. The progression of the disease varies among individuals, with some experiencing mild symptoms and others developing more severe complications. The condition can also lead to fatigue and joint pain. As the disease progresses, it may affect the ability to produce saliva and tears, impacting daily activities and quality of life.