Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Sjögren’s syndrome, a condition where the body’s immune system mistakenly attacks its own moisture-producing glands, leading to symptoms like dry mouth and eyes. The treatment being tested is called ianalumab (also known by its code name VAY736), which is a type of medication known as a monoclonal antibody. This medication is designed to target specific parts of the immune system to help reduce the symptoms of the disease. In this study, some participants will receive ianalumab, while others will receive a placebo, which looks like the treatment but does not contain the active medication.

The purpose of the study is to determine if ianalumab is more effective than a placebo in improving the condition of patients with active Sjögren’s syndrome. Participants in the study will receive the treatment or placebo through an injection under the skin, known as a subcutaneous injection, over a period of 52 weeks. Throughout the study, participants will be monitored to assess changes in their symptoms and overall health.

This trial aims to provide valuable information on the safety and effectiveness of ianalumab for treating Sjögren’s syndrome, potentially offering a new option for managing this condition. Participants will be closely observed by healthcare professionals to ensure their well-being and to gather data on how the treatment affects their symptoms over time.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups: one receiving the active medication ianalumab (also known as VAY736) and the other receiving a placebo. This process is double-blind, meaning neither the participants nor the researchers know who is receiving the active medication or the placebo.

2 treatment administration

Participants receive the assigned treatment through subcutaneous injection using a pre-filled syringe. The active medication, ianalumab, is administered at a dose of 150 mg per 1 mL.

The treatment period lasts for 52 weeks, during which the medication is administered according to the study protocol.

3 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor the effectiveness and safety of the treatment. These assessments include measuring changes in the ESSDAI score, which evaluates disease activity in Sjögren’s syndrome.

Additional assessments may include evaluations of salivary flow rate, systemic disease activity, and patient-reported outcomes.

4 end of treatment evaluation

At the end of the 52-week treatment period, participants undergo a final evaluation to assess the overall impact of the treatment on their condition.

The primary focus is on the change in the ESSDAI score from the beginning of the study to the end of the treatment period.

Who Can Join the Study?

  • You must sign a form to show you agree to participate in the study.
  • If you are taking systemic corticosteroids (a type of medication that reduces inflammation), your dose must be stable at 10 mg or less per day for at least 30 days before starting the study. The dose should stay the same during the study, but small changes are allowed.
  • If you are taking certain medications called disease-modifying antirheumatic drugs (DMARDs) or specific Traditional Chinese Medicines, you must stop these at least 30 days before starting the study. One exception is a medication called leflunomide, which must be stopped 8 weeks before unless a special procedure is done.
  • You must be 18 years of age or older.
  • You must have Sjögren’s syndrome diagnosed according to specific criteria from 2016.
  • You must have been diagnosed with Sjögren’s syndrome for 7.5 years or less at the time of screening.
  • You must have a positive test for anti-Ro/SSA antibody at screening. If this test is negative, you can still participate if a salivary gland biopsy is positive, but only a small number of such patients will be included.
  • Your ESSDAI score (a measure of disease activity) must be 5 or higher in certain areas of the body.
  • Your salivary flow rate (how much saliva you produce) must be at least 0.05 mL per minute at screening.
  • You must be able to communicate well with the study team and agree to follow the study requirements.
  • If you are taking medications like hydroxychloroquine, methotrexate, or azathioprine, you can continue them if the dose has been stable for at least 30 days before starting the study and stays stable during the study.

Who Cannot Join the Study?

  • Patients with any other autoimmune disease that might interfere with the study results.
  • Patients who have had a serious infection within the last 3 months.
  • Patients who have received any live vaccines within 4 weeks before the study starts.
  • Patients who are currently receiving treatment with another investigational drug.
  • Patients with a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients with severe heart, liver, or kidney problems.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients with a known allergy to the study medication or its ingredients.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Landesklinikum Stockerau Stockerau Austria
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
CHU Grenoble Alpes La Tronche France
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hospital Universitario Basurto Bilbao Spain
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Instituto Portugues De Reumatologia Lisbon Portugal
Medical Plus s.r.o. Uherske Hradiste Czechia
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Affidea Praha s.r.o. Prague Czechia
Virgen del Rocío University Hospital Sevilla Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Unidade Local De Saude Da Guarda E.P.E. Guarda Portugal
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Wroclaw Poland
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Rheumatologische Schwerpunktpraxis Erlangen Erlangen Germany
Rwsozxcddnwh sipfjf Brno-Sever Czechia
Pvhv Tzqdb Hohelmxu Uvmmlirlxrwz Sabadell Spain
Cfgvsx Hxqwqusqzhe Ueyriyjabaqcw Du Dlqjo Dijon France
Adseyuzlzd Pssusdmo Hyeofwgo Dm Mpobwaueu Marseille France
Hanxcuso Uoyetsfugtpjg Hlynuzhh Tkhfp y Pzzvbh Iqfcmmin Cxbmiu ddsjmgrmqjdoyqpdm (htkw Badalona Spain
Iukzdjmu dj Chcfycqwnnbg Hermypztppp Uklpjlwcwpcpe dh Szvxn Ebmmjlz (titkioh Saint Priest En Jarez France
Icmoewdt Ujp Kaunas Lithuania
Hhwiomdj Ugqroftfxvlzg di A Cpquxi A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
28.07.2022
Belgium Belgium
Not recruiting
28.07.2022
Czechia Czechia
Not recruiting
28.07.2022
France France
Not recruiting
28.07.2022
Germany Germany
Not recruiting
28.07.2022
Lithuania Lithuania
Not recruiting
28.07.2022
Poland Poland
Not recruiting
28.07.2022
Portugal Portugal
Not recruiting
28.07.2022
Spain Spain
Not recruiting
28.07.2022

Trial locations

Investigated drugs:

Ianalumab is a medication being studied for its effectiveness and safety in treating patients with active Sjögren’s syndrome. The trial aims to show that ianalumab can improve symptoms of the disease, as measured by a specific score, over a period of 48 weeks.

Sjögren’s Syndrome – Sjögren’s Syndrome is an autoimmune disorder primarily affecting the glands that produce tears and saliva, leading to dry eyes and mouth. It can also impact other parts of the body, including joints, kidneys, lungs, and nerves. The disease often progresses slowly, with symptoms developing over time. Patients may experience fatigue, joint pain, and swelling. In some cases, Sjögren’s Syndrome can occur alongside other autoimmune diseases, such as rheumatoid arthritis or lupus. The severity and combination of symptoms can vary widely among individuals.

Trial ID:
2024-511069-12-00
Protocol code:
CVAY736A2301
NCT ID:
NCT05350072
Trial Phase:
Therapeutic confirmatory (Phase III)

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