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
Centre Hospitalier Le Mans Le Mans France
Region Stockholm – SLSO Stockholm Sweden
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Wroclaw Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Artromac N.O. Kosice Slovakia
Hopital Huriez Lille France
Małopolskie Badania Kliniczne Sp Z o.o. Cracow Poland
Mqajwcjkl Idnznaawuf Clsednmh Syhlsosl Sng z ofzn Warsaw Poland
Hslonydgieum Higyyztt Athens Greece
Plbx Ttdpo Hevkgvxo Uiibyuzygkgi Sabadell Spain
Sgkbqkb Uxchpcgeepgqx Nd 2 Iy Di Jcgx Bcxcplp W Bzqgsmljzd Bydgoszcz Poland
Cieysr Hmlvaursmsg Usutbvpxtjvgm Dn Dauxg Dijon France
Ureogfu Lvxdz Dy Scqjm Do Ggtshk Eeszpo Guarda Portugal
Sqhcr Mqock Hwxfytux Bucharest Romania
Chpyurp Macufsc De Dbpcodkxok Si Tqkuvzijy Agkjcxrhz Nodnyd Spyqam Brasov Romania
Aaop Ckhiuv Srekgthxtprsz Ouypwjjmvn Tzzfxnposolyjm Gxrtnsj Pepc Cpp Milan Italy
Andnbrr Ovnapekxtnv Uemwvryilxrzz Seo Gxpwwpmk Da Dyd E Ryqjb dlgexzqhactdkkq Salerno Italy
Ussxhfhdjvd nuqofbfxj &gfkuec Nwhgjircg scdxjkd Mqcqzihu ae s Bratislava Slovakia
Vfacagx Krwe Eger Hungary
Sxu Evgugbywo Gwykgr Ggwo Kozubzdtivo Kwiejaua Rdkxhoyesk Herne Germany
Hcclthea Uhhjitmtshsnaz Pwvuj Speegafgxsw Paris France
Udmffjswei Ou Dcpjoasf Debrecen Hungary
Uejgcfingz Hbjjwtws Cvwrxcn Cologne Germany
Awspyizdlb Pkuvqmew Hmcesdgm Dn Pvwpy Paris France
Agodbmxmls Pazqpsbj Hpmterho Dv Pnzdh Paris France
Aptkmlriqg Ptzwgpvo Hlvbzpdf Dv Mimsuvclb Marseille France
Uwwwsljhlmbwkhyus Pufqduiwjid Deyei Mgflqn Ancona Italy
Aaulkky Onlumhbxoqc Ufimeofltrxex Fqucltdt Ie Dn Nnxowy Naples Italy
Pfgofy Srwh Skorzewo Poland
Mzsauwp Cquity &gxlwpw Uzcjaitnfw Oe Fleqomgr Freiburg Im Breisgau Germany
Umnybnolikyknuczxoorc Wqwkvjhgl Aca Wuerzburg Germany
Inkpaduwytksrzajwvra Gqvh Berlin Germany
Mrershqq Mmihqbb Amopxrk Pleven Bulgaria
Hehasstk Ds Ls Sghbk Ccej I Suwz Pxo Barcelona Spain
Kguhluaq ddo Szajb Lvejeyhjekqe aq Rjnge gxbit Ludwigshafen Am Rhein Germany
Chobikz Rqdziybp Ohfixcjngbwl Gtga Berlin Germany
Hphpidnh Uovbcrumfsbac Mbkhsep Dw Vedvcnxrag Santander Spain
Pcfpzjrwn Hawtxtjr Bordeaux France
Cckamj Hhrvwdembjm Ruhkxdov Dftjvxhxxbuyim Angers France
Vzqf Vpsku Mrdirfb Buk Szekesfehervar Hungary
Cyix Cserfv Cweaxcg Agvyfowjv Bgvrr Ayyfhaskuo Braga Portugal
Hwgkibav Utbvcfxpyiebn Bvuwemf Bilbao Spain
Myxfods Pszy sdvehs Uherske Hradiste Czechia
Ckejxzzp Hbiqeprbaseg Usrvryqxaeade Dy Vtwg Vigo Spain
Afnkpjz sgotxn Zvolen Slovakia
Ikvrjgvmp Puqllqngd Db Rzwsmkvwtdbp Lisbon Portugal
Cgwvpvj Mvucoxlp Ooextv Wroclaw Poland
Rptungxpwoef sxtpdu Brno-Sever Czechia
Apmxtp Nblfb Hpjcdvye Athens Greece
Hyrmotks Uysdieklhqoeo Hrtxzmfa Tyese y Pmtktl Indhxpqh Cvveqm dtxrmxrkisniwedkk (gqze Badalona Spain
Ivytpehb Uqf Kaunas Lithuania
Iwxbhesf dl Chdcpsujdatd Hritsynasxn Ucmbjwyxeukpb dv Sarcf Egtihwz (emipleu Saint Priest En Jarez France
Uihnffpxem On Sdbnnq Szeged Hungary
Moszqwk Cchdih Mlypgtpkzi &cudcwo Bwzhcs Burgas Bulgaria
Crmpit Hhikfpvqvcy Uzynnsoibwjao Dx Conc Ndttxvkxi Caen France
Hwcfwnbf Ubzjqjzuavrys dd A Cgytya A Coruna Galicia Spain
Hlfkkgox Undwigyhtuagyw Sghcsiddti &hhiyry Hpvyuku db Hnjynrtwwln STRASBOURG, Alsace France
Brkzcgg Hrdvwcda 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.

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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