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

What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.)

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland

Verified Sites

Site Name	City	Country
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
University Hospital Jena KöR	Jena	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Reumedika s.c.	Poznan	Poland
NZOZ LECZNICA MAK-MED s.c.	Nadarzyn	Poland

Other Sites

Site Name	City	Country
Vita Verum Medical Bt.	Szekesfehervar	Hungary
Rcmed Oddzial Sochaczew	Sochaczew	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Malopolskie Badania Kliniczne Sp. z o.o.	Cracow	Poland
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg	Germany
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Medical Plus s.r.o.	Uherske Hradiste	Czechia
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej	Wroclaw	Poland
Ambulatorium Sp. z o.o.	Elblag	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
University Of Debrecen	Debrecen	Hungary
Hospital Clinico Universitario De Valencia	Valencia	Spain
Hospital Quirón Salud Infanta Luisa	Sevilla	Spain
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hopital Beaujon	Clichy	France
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
Medicover GmbH	Oldenburg In Holstein	Germany
Mztxvqgxu Ibsmpblzwq Cnjmiigh Sdpjorqo Sju z ozzc	Warsaw	Poland
Rbzhrcnilfdx sjrqvx	Brno-Sever	Czechia
Hpgxumwa Ungvmdpjfmydp Rhlohfvh Ds Mismpp	Malaga	Spain
Pcxi Tjxcv Hpcphryg Uingwqitfspv	Sabadell	Spain
Mwgccmmed Mvdkvue ghnkz	Munich	Germany
Kitnohns dic Uombniydquhm Mqbkszis Azz	Munich	Germany
Hcjvelqv Dd Ls Shuwe Clxo I Scat Pse	Barcelona	Spain
Hsbqihyw Uawyvqixojpws dc A Cbszwd	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.11.2024
France	Not recruiting	01.11.2024
Germany	Not recruiting	01.11.2024
Hungary	Not recruiting	01.11.2024
Poland	Not recruiting	01.11.2024
Spain	Not recruiting	01.11.2024

Trial locations

Investigated drugs:

Kpl-404

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.

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.

Trial ID:

2024-512986-15-00

Protocol code:

KPL-404-C221

Trial Phase:

Therapeutic exploratory (Phase II)

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

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