Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called ianalumab for patients with Sjögren’s syndrome. Sjögren’s syndrome is an autoimmune disease where the body’s immune system mistakenly attacks its own moisture-producing glands, leading to symptoms like dry mouth and dry eyes. The study involves the use of ianalumab, which is administered as a solution for injection. Participants in the study may also receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of the study is to assess how well ianalumab works over a long period and to monitor any side effects that may occur. Participants will be randomly assigned to receive either ianalumab or a placebo. 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. This helps ensure that the results are not biased. The study will continue for several years, allowing researchers to gather comprehensive data on the treatment’s safety and effectiveness.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. Blood samples will be taken to measure the levels of ianalumab in the body and to check the number of B-cells, which are a type of immune cell. The study aims to provide valuable information on the potential benefits of ianalumab for people living with Sjögren’s syndrome, contributing to better treatment options in the future.

1 joining the study

Participation begins after signing an informed consent form. This confirms understanding and agreement to participate in the study.

Eligibility requires previous participation in one of the NEPTUNUS core studies and completion of treatment up to Week 48 without discontinuation.

2 treatment phase

The main objective is to assess the long-term safety and tolerability of ianalumab in individuals with Sjögren’s syndrome.

Participants receive ianalumab administered subcutaneously. The specific dosage and frequency are determined by the study protocol.

3 monitoring and assessments

Regular monitoring includes checking for any treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs).

Assessments involve measuring changes in the ESSDAI and ESSPRI scores, which evaluate disease activity and symptoms.

Blood samples are collected to measure ianalumab serum concentrations and B-cell counts at specified intervals, such as Week 52 and Week 64.

4 follow-up

The study continues with follow-up assessments to monitor long-term effects and safety up to Week 204.

Participants’ progress and response to treatment are evaluated throughout the study duration, which is estimated to end by January 6, 2031.

Who Can Join the Study?

  • You must have signed a document called an informed consent before joining the study. This document explains the study and confirms that you agree to participate.
  • You must have taken part in one of the two previous studies named NEPTUNUS, specifically studies CVAY736A2301 or CVAY736A2302, and completed all treatments up to Week 48 without stopping the treatment early.
  • The study doctor must believe that you will continue to benefit from the treatment with the medication called ianalumab.
  • Both men and women can participate in the study.
  • The study is open to adults, which means you must be at least 18 years old.

Who Cannot Join the Study?

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of severe allergic reactions to medications.
  • Using certain medications that might affect the study results.
  • Having participated in another clinical trial recently.
  • Having a history of drug or alcohol abuse.
  • Having an infection that requires treatment with antibiotics.
  • Having a history of cancer, except for some types of skin cancer.
  • Having a weakened immune system, which means the body’s defense against infections is not strong.
  • Having a history of certain blood disorders.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hippokration Hospital Athens Greece
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Centre Hospitalier Le Mans Le Mans France
University Multiprophy Hospital For Active Treatment – Plovdiv AD Plovdiv Bulgaria
Unidade Local De Saude Da Guarda E.P.E. Guarda Portugal
Saint Maria Hospital Bucharest Romania
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Region Stockholm – SLSO Stockholm Sweden
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Wroclaw Poland
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Hopitaux Universitaires Pitie Salpetriere Paris France
University Of Debrecen Debrecen Hungary
Universita’ Politecnica Delle Marche Ancona Italy
Pratia S.A. Skorzewo Poland
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Charite Research Organisation GmbH Berlin Germany
Pellegrin Hospital Bordeaux France
Vita Verum Medical Bt. Szekesfehervar Hungary
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hospital Universitario Basurto Bilbao Spain
Medical Plus s.r.o. Uherske Hradiste Czechia
Artromac N.O. Kosice Slovakia
Albamed s.r.o. Zvolen Slovakia
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Instituto Portugues De Reumatologia Lisbon Portugal
Centrum Medyczne Oporow Wroclaw Poland
Athens Naval Hospital Athens Greece
University Of Szeged Szeged Hungary
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hopital Huriez Lille France
Manidgmnf Ilbipzcodv Csevxvue Setuqmwl Soq z oljq Warsaw Poland
Pvgx Tlcqx Hznjfggz Ummtllsaisdr Sabadell Spain
Clxyjk Hapkvonfgax Utuoiqdkikdnt Dg Dnwel Dijon France
Cwisncz Mqooyeh Dq Dmfrfhvmwe So Toscyzzud Apesrfzdd Nrnjnl Skcihy Brasov Romania
Uswztbqeqaw nqqfiqsor &pocfmq Nyajbrpxq skglrxp Mvudtbmb ad s Bratislava Slovakia
Vfodrue Kjbx Eger Hungary
Uncftsrguy Hrpxhngm Cuyvqcv Cologne Germany
Acgxufuira Pygxbwij Hnxeeiyj Dq Pyicz Paris France
Axkdufylcq Pcupcpzy Hpyzujgy Dj Pywlp Paris France
Aiwrlllpeu Pqhrsrbz Hsdtwlyw Dw Msrsojwuv Marseille France
Uzstcyrknfgbxtujzabka Wegkenxzk Aki Wuerzburg Germany
Ixcdgaucpvhxrhffqtjw Gkfx Berlin Germany
Mnbahsfi Mehivzz Awjixpl Pleven Bulgaria
Hjvwdnxp Df Lp Sgkym Cpro I Szgp Pug Barcelona Spain
Hlqjroiu Usscucxgocyhr Mdstsra Dp Vicaoyjrje Santander Spain
Cuebkx Hgvwlzfnfwd Ruepuwpp Dtwkaolchhjtvl Angers France
Cxihgbcb Hmwnzxvqcwzy Uelioyfwmsafv Dy Vqet Vigo Spain
Rupsmbwmxclq sdhkqf Brno-Sever Czechia
Hhhodkds Uubphvyithuxj Hihxhqmz Tywph y Pjcpoa Iidywfcj Cjwnvo dwiflpkftgpkthqfm (smea Badalona Spain
Ikfnehfw Ujn Kaunas Lithuania
Ippjwggc db Cubogilnzmhd Hypegclpgoz Urfcelmaddbxp dy Sgpoq Eafibtp (prsvsnj Saint Priest En Jarez France
Mryzpkl Ckxlgi Muqxurictv &fvxfeq Bpdzkv Burgas Bulgaria
Huivrfyb Uvtautdzviobj dn A Cjhacj A Coruna Galicia Spain
Htdturdi Udgozotbhpvxzp Syuaahkzur &pgfhos Hpxyejg dg Hsvkihepupl STRASBOURG, Alsace France
Clc Kpzrnin Bequamt Le Kremlin-Bicetre France

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
22.09.2023
Belgium Belgium
Not recruiting
22.09.2023
Bulgaria Bulgaria
Not recruiting
22.09.2023
Czechia Czechia
Not recruiting
22.09.2023
France France
Not recruiting
22.09.2023
Germany Germany
Not recruiting
22.09.2023
Greece Greece
Not recruiting
22.09.2023
Hungary Hungary
Not recruiting
22.09.2023
Italy Italy
Not recruiting
22.09.2023
Lithuania Lithuania
Not recruiting
22.09.2023
Poland Poland
Not recruiting
22.09.2023
Portugal Portugal
Not recruiting
22.09.2023
Romania Romania
Not recruiting
22.09.2023
Slovakia Slovakia
Not recruiting
22.09.2023
Spain Spain
Not recruiting
22.09.2023
Sweden Sweden
Not recruiting
22.09.2023

Trial locations

Ianalumab is a medication being studied for its long-term safety and effectiveness in treating patients with Sjögren’s syndrome. Sjögren’s syndrome is an autoimmune disease that primarily affects the glands that produce tears and saliva, leading to dry mouth and eyes. Ianalumab is designed to help manage the symptoms of this condition by targeting specific parts of the immune system. The goal of the study is to determine how well patients tolerate the medication over an extended period and to evaluate its overall safety.

Investigated diseases:

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 affect other parts of the body, including joints, skin, and organs. The disease progresses slowly, with symptoms often developing over several years. Patients may experience fatigue, joint pain, and swelling. In some cases, it can lead to complications such as dental cavities, oral yeast infections, or vision problems. The severity and progression of symptoms can vary widely among individuals.

Trial ID:
2022-502966-26-01
Protocol code:
CVAY736A2301E1
Trial Phase:
Therapeutic confirmatory (Phase III)

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