Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called ianalumab in adults with autoimmune diseases, specifically Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Sjögren’s Disease. Autoimmune diseases occur when the body’s immune system mistakenly attacks its own tissues. The study aims to compare how the body processes ianalumab when given in different forms, such as a pre-filled syringe or an auto-injector. Ianalumab is a type of protein-based medication designed to help manage these conditions by targeting specific parts of the immune system.

Participants in the study will receive ianalumab through subcutaneous injections, which means the medication is administered under the skin. The study will take place over a period of time, allowing researchers to observe how the medication is absorbed and processed by the body. The goal is to ensure that the different forms of administering ianalumab are equally effective and safe for patients. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of ianalumab.

In addition to ianalumab, the study will also involve other medications such as emtricitabine, tenofovir disoproxil, tenofovir alafenamide, and entecavir, which are typically used to manage viral infections. These medications will be administered orally, meaning they are taken by mouth. The study will monitor various health indicators, including any side effects, to ensure the safety and effectiveness of the treatments. The overall purpose is to gather information that could lead to better treatment options for people with these autoimmune diseases.

1 joining the study

Upon joining the study, the participant will have already provided signed informed consent. This is a necessary step before any assessments or treatments begin.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes verifying age, weight, body mass index (BMI), and diagnosis of rheumatoid arthritis, systemic lupus erythematosus, or Sjögren’s disease.

3 treatment phase 1

Participants will receive ianalumab, a medication administered subcutaneously (under the skin). The dosage is 300 mg, and it will be given using either a 2 mL auto-injector or two 1 mL pre-filled syringes.

This phase aims to compare how the body absorbs and processes the medication using different delivery methods.

4 monitoring and evaluation

Participants will be monitored for serum concentrations of ianalumab at specific intervals after the third dose (between weeks 8 and 12) and the sixth dose (between weeks 20 and 24).

Additional evaluations will include checking for adverse events, laboratory tests, vital signs, and ECG parameters.

5 treatment phase 2 (optional)

In an optional second phase, participants may receive ianalumab using a different combination of delivery methods: a 2 mL pre-filled syringe or two 1 mL pre-filled syringes.

This phase also focuses on comparing how the body absorbs and processes the medication.

6 final assessments

At the end of the study, participants will undergo final assessments to evaluate the presence of anti-ianalumab antibodies and any other long-term effects of the treatment.

Who Can Join the Study?

You must sign a form to show you understand and agree to join the study before any tests are done.
You need to be between 18 and 70 years old.
Your body weight should be at least 35 kg and not more than 150 kg. Your Body Mass Index (BMI) should be between 18 and 35. BMI is a number calculated from your weight and height.
You must have been diagnosed with one of the following conditions: Rheumatoid Arthritis (RA), Sjögren’s Disease (SjD), or Systemic Lupus Erythematosus (SLE).
Your condition (RA, SjD, or SLE) should be active and might improve with a treatment that reduces certain immune cells called B-cells.
If you are taking any regular medications allowed by the study, you should have been on a stable dose for at least 4 weeks before starting the study treatment.
You should be able to communicate well with the study doctor and understand and agree to follow the study’s requirements.

Who Cannot Join the Study?

Patients with Rheumatoid Arthritis cannot participate. This is a condition where the body’s immune system attacks its own joints, causing pain and swelling.
Patients with Systemic Lupus Erythematosus are excluded. This is a disease where the immune system attacks different parts of the body, like the skin, joints, and organs.
Patients with Sjögren’s Disease cannot join. This is a condition where the immune system attacks glands that produce moisture, like tears and saliva.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Reumed Sp. z o.o.	Lublin	Poland
Qualiclinic Kft.	Budapest	Hungary
Malopolskie Badania Kliniczne Sp. z o.o.	Cracow	Poland
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona	Salerno	Italy
Revita Kft.	Budapest	Hungary
Medical Plus s.r.o.	Uherske Hradiste	Czechia
University Of Debrecen	Debrecen	Hungary
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Rheumazentrum Ratingen	Ratingen	Germany
Rswetmvgpfak sjnrdi	Brno-Sever	Czechia
Hvrcfoaf Ulkptcuptqzhk dh A Csvips	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	12.06.2024
Germany	Not recruiting	12.06.2024
Hungary	Not recruiting	12.06.2024
Italy	Not recruiting	12.06.2024
Poland	Not recruiting	12.06.2024
Spain	Not recruiting	12.06.2024
The Netherlands	Not recruiting	12.06.2024

Trial locations

Investigated drugs:

Ianalumab is a medication being studied for its effects on autoimmune diseases. In this clinical trial, researchers are examining how the body absorbs and processes ianalumab when it is given in different forms. The study compares the use of an auto-injector and pre-filled syringes to see if they deliver the medication in a similar way. This helps ensure that patients receive the same benefits from the medication, regardless of how it is administered.

Investigated diseases:

Rheumatoid Arthritis – A chronic inflammatory disorder that primarily affects the joints, causing pain, swelling, and stiffness. Over time, it can lead to joint damage and deformities. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees and hips. It may also affect other body systems, including the skin, eyes, and lungs. The exact cause is unknown, but it involves the immune system attacking the body’s own tissues. Symptoms can vary in severity and may come and go.

Systemic Lupus Erythematosus – An autoimmune disease where the immune system attacks healthy tissues, affecting multiple organs and systems. It can cause a wide range of symptoms, including fatigue, joint pain, skin rashes, and fever. The disease is characterized by periods of illness, called flares, and periods of remission. It can affect the skin, kidneys, brain, and other organs. The exact cause is unknown, but it is believed to involve genetic and environmental factors. Symptoms can vary greatly between individuals.

Sjögren’s Disease – An autoimmune disorder characterized by dry eyes and dry mouth due to the body’s immune system attacking its own moisture-producing glands. It can also affect other parts of the body, including the joints, thyroid, kidneys, liver, and lungs. The disease often accompanies other autoimmune disorders, such as rheumatoid arthritis or lupus. Symptoms can include difficulty swallowing, persistent dry cough, and fatigue. The cause is not fully understood, but it involves a combination of genetic and environmental factors. Symptoms can range from mild to severe.

Trial ID:

2023-508996-35-00

Protocol code:

CVAY736A2202

NCT ID:

NCT06293365

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?