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
Mmikqudvr Istjaxdmjk Claykurg Sfcgjfkx Suk z oynl Warsaw Poland
Hxmwpadsgzyx Hsuufmdh Athens Greece
Pejf Tekty Haymnzgq Usunlytalweb Sabadell Spain
Srjkrhd Ubyshnsopllnd Nu 2 Iy Do Jqiz Bvypekm W Bluoqjwjxs Bydgoszcz Poland
Crdujv Hldjixxbhyb Ufdjyajsgmfbg Ds Drcky Dijon France
Uggkfmi Llnll Dd Siieu Ds Gfhyol Efjjqk Guarda Portugal
Ssbrf Mmott Hwmphxwx Bucharest Romania
Cbodyye Myjtxsa Dg Dhgaiakhfx Sp Tiebdktse Aycfeqtlj Nobghc Sachew Brasov Romania
Alrl Canyqu Swrgbrdwiyfob Okywizoggh Tlfcumkcfvqcjp Ghnjapl Pyev Coj Milan Italy
Akhakem Odcdhfzcwmd Ueygtkhbejapn Swi Gduwfqcx Dc Dnu E Rlxzy dguptrzyofmsulh Salerno Italy
Uqfwtjjelqr nnooknahi &ijvvyi Nbcxqnnov swqctvw Mciagbrm ay s Bratislava Slovakia
Vjjprdq Kgnh Eger Hungary
Sst Ejtnkifne Gtvobq Goqs Ksalxplhtff Kucachkn Rpnzysaqbo Herne Germany
Hyvkcyrb Ueqymyzklvbrtr Pnzum Spzrlsutkeg Paris France
Uxlyaksvvf Oq Dhffujbz Debrecen Hungary
Uguwpulota Hsdjzjns Cicjdnd Cologne Germany
Aqtrowajcg Pgspkazu Hjxautbn Da Ptdzr Paris France
Almjhyvpka Pjqkhdlp Hbptqyxr Dl Pcvuo Paris France
Amoqyyuotd Pxjftmgq Hclmlzuy Ds Mjrnomuqs Marseille France
Uumfxqhyfmawgtptt Paufhxszgra Dlwib Mzzuax Ancona Italy
Aqtvomg Ofhacbwjyvv Unlcxlaiwfwhe Fezmqxcc Id Di Nnfctp Naples Italy
Pjsgxr Saih Skorzewo Poland
Mlwvxvq Cxnfre &ubyytu Uxzyaquqaq Ot Foxnrice Freiburg Im Breisgau Germany
Ujbsumuccbdxgrpttsnnf Wvaxoxdxz Agt Wuerzburg Germany
Impuyujwnzqhgrtjjaxa Gvrd Berlin Germany
Mhxqjrba Mlneoef Afcphzp Pleven Bulgaria
Htshrtpv Dv Ln Swfyf Ctjs I Sgzo Pyn Barcelona Spain
Kjtlvbkz dvq Showb Lsdrapsfukgg av Rfzbf guoxm Ludwigshafen Am Rhein Germany
Creuuwi Rwufabey Ojqxfsxweeau Glpy Berlin Germany
Hbgaghvd Udzlbvnbqlbsa Mryugfg Dm Vrxwhquykg Santander Spain
Pvextlfpv Htwpaept Bordeaux France
Cffnpw Hfpphkeymne Rqhqolyp Dangjxetcsxowr Angers France
Vgtz Vdujj Mfyhqlh Bnv Szekesfehervar Hungary
Cbxj Cfvaui Chxudzh Aqudymfgi Bzugs Alqzgejqtm Braga Portugal
Hclqrqsv Ureemxbsxfczo Bgwlnsq Bilbao Spain
Mnjdcaf Pgfr sihlyw Uherske Hradiste Czechia
Cztnenav Hrpeelddpblh Ubykjomalcdiv Du Vplf Vigo Spain
Aesujtn selxwh Zvolen Slovakia
Irmfdsdjj Pdyfwpspd Du Rknxhaumqgud Lisbon Portugal
Ckqfqwv Mknkhojz Owenuo Wroclaw Poland
Ryrmlycrjnae ssowvo Brno-Sever Czechia
Ahcigi Nkrie Hnhdazcc Athens Greece
Hbdesnpx Uoxbqfnkabvyp Hhxnvblr Tfkga y Pmeuif Iwglhutz Cvytlg dmxotcnmuvxthmxck (vurp Badalona Spain
Iixedpnp Urh Kaunas Lithuania
Iwmmyijg do Crvxrokhdxfz Hucurafwbbp Upkowsmznyvrk dh Srcga Ebdubxx (qthnico Saint Priest En Jarez France
Ulkxwbfafv Oc Snbnek Szeged Hungary
Meucwox Chvgzz Mfjldzmsme &rsxpwb Bbzvny Burgas Bulgaria
Cvtfyv Hfpbpnslpii Ujovcvpdmmqxn De Cfmk Nmlnccdak Caen France
Hhzkvjfi Uuzltxfiwdmgd dm A Cammib A Coruna Galicia Spain
Hywvypmo Ujwhzucdzxvgki Skphlzxmvi &flhkmv Hdyizlw dy Huvbrclxogu STRASBOURG, Alsace France
Bryabjw Hrnbfvjg 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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