Study on Long-Term Safety of Ianalumab for Patients with Systemic Lupus Erythematosus

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What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a treatment called ianalumab in patients with Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease where the body’s immune system mistakenly attacks healthy tissue, causing inflammation and damage to various parts of the body. The study involves administering ianalumab, which is given as a solution for injection under the skin, either monthly or quarterly. The purpose of the study is to evaluate how safe and well-tolerated ianalumab is over an extended period.

Participants in the study may receive ianalumab or a placebo. The study will monitor participants for any side effects or adverse reactions that may occur during the treatment period. The study will also assess the overall health and condition of the participants over time, including any changes in their disease symptoms and the use of other medications, such as oral corticosteroids, which are often used to reduce inflammation in SLE.

The study is designed to last for several years, allowing researchers to gather comprehensive data on the long-term effects of ianalumab in treating SLE. Participants will be regularly evaluated to track their progress and any changes in their condition. This research aims to provide valuable insights into the potential benefits and risks of using ianalumab as a treatment option for individuals living with Systemic Lupus Erythematosus.

1 joining the study

Participation begins after signing an informed consent form. If under 18, a parent or guardian must also sign, and the participant must give assent. If the participant reaches the age of consent during the study, they must sign the consent form at the next visit.

2 eligibility confirmation

Eligibility requires prior participation in one of the SIRIUS-SLE core studies and completion of the treatment period through Week 60 without discontinuation. The investigator must determine that continued treatment is expected to be beneficial.

3 treatment administration

The study involves the administration of ianalumab at a dose of 300 mg. This is given as a subcutaneous injection, either monthly or quarterly, depending on the assigned regimen.

4 monitoring and assessments

Participants will be monitored for any treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs).

The study will assess the proportion of participants achieving a specific response (SRI-4) and changes in a damage index (SLICC/ACR) up to Week 216.

The average daily dose of oral corticosteroids and the rate of moderate or severe disease flares will also be evaluated annually up to Week 216.

5 study duration

The study is expected to continue until December 23, 2031. Recruitment is estimated to start on May 21, 2024.

Who Can Join the Study?

  • You must sign a document called an informed consent before joining the study. If you are under 18, your parent or legal guardian must sign it, and you must agree to participate. If you become old enough to give consent during the study, you will need to sign the form yourself at your next visit.
  • You must have been part of one of the two previous studies called SIRIUS-SLE, specifically studies CVAY736F12301 or CVAY736F12302, and completed the treatment period up to Week 60 without stopping the treatment.
  • The study doctor must believe that you will benefit from continuing the study treatment.
  • Both males and females can participate in the study.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary
Hospital General Universitario De Valencia Valencia Spain
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Wroclaw Poland
Hospital Universitario De Canarias La Laguna Spain
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Artromac N.O. Kosice Slovakia
Rpmxsgfovldeko Umnhp Prague Czechia
Mbpjebrmg Igpbijttxr Cvncpjah Saorwpto Siy z oopz Warsaw Poland
Afitidt Ozaqsrkenbs dj Paqrfu Padua Italy
Hqcvqtgl Viva dvvppnzh Barcelona Spain
Utlspeeuux Hlcisyvj Cachwvl Cologne Germany
Cbaadvj Uxxqjdmylpmcyzcvrihq Blqfdl Klz Berlin Germany
Chdqoh Hltknjlivre Rsaskdth Uqxlptgxcipye Dz Tikof Tours France
Coqffs Hsrwkflgzrx Uvjdgdljuzefz Dp Mwsizibvnzb Montpellier France
Uearxvzlwzmeaunrg Pivvmtxszyp Dmset Myqorc Ancona Italy
Ugfarinjnnju Ds Smhvpovg Ds Cugietvhhz Santiago De Compostela Spain
Mqxuvjq Cvejco &iktxrf Ufwxtyknpo Og Fbjeefsq Freiburg Im Breisgau Germany
Urxelunavujj Lovevhu Leipzig Germany
Hapmqzlg Uecexwfkdlbvl Mnrfgcr De Vpzytjskds Santander Spain
Uendsythvgmrzutqw Dddwz Sfsqd Dg Fnrslvr Ferrara Italy
Cejrdwh Mnydqms Dv Dtrtdjnwta Sd Tlxhejbov Abndfhqmo Nlumgc Sbjglk Brasov Romania
Hnfprpje Uyckuzoneczob Rnt Hlhqtwg Valladolid Spain
Ciin Ctuqok Cbcqpvk Affhzapgf Brdkj Awzmrqxrwe Braga Portugal
Ctnvewbn Hngzqddiedjq Urqjnjclvayaj Dd Vplf Vigo Spain
Hpyavfue Upofxhpfwgbrr Ikxlmzm Sllda San Sebastian De Los Reyes Spain
Azseoga Oppstirphdc Uwbctftymtonb Pgwvgp Pisa Italy
Sqnrxul Upmfuvmiodhgg Nk 2 Id Dr Jbra Bzwfzks W Bshspikqmt Bydgoszcz Poland
Ukatowhwekr nitgtjqez &cmzxnd Nkkgrumha sjscueb Mwgcclzx af s Bratislava Slovakia
Hetktpnp Upiwaymttzxkv Asluw Vitoria Spain
Bntpvskco Efjizhxodqs Kvec Zalaegerszeg Hungary
Aqrebfu Oslolycpkbc Sowk Aolu E Sbz Sioqtovhvr Da Ckfapcd Caserta Italy
Sas Erxbkifdv Ghphus Gffo Kpjgupijhcm Kqavdmew Rhctocwdkq Herne Germany
Svjeq Mahul Heftwjqv Bucharest Romania
Urkujmn Lxxgz Dn Soyio Db Gwrfaanmnfhx Etlwom Vila Nova De Gaia Portugal
Snp Cbsvqxl Fzwrfjhjq Hfpjglgk Rome Italy
Vtvy Vpkrt Mkplfwy Bny Szekesfehervar Hungary
Aeza Ckaxlz Sbkwcrutolzau Ooahhmhfxi Tfhzyubpevutum Gwesaff Piou Caz Milan Italy
Mkfjnak Pncn sqrodu Uherske Hradiste Czechia
Uymafvvntu Mexoayycupab Hforeokg Fdm Asqzfe Tvxziossk Kxzjzbh Ebyv Plovdiv Bulgaria
Qdqbsmnfxyz Kdfd Budapest Hungary
Ihtrxvbdh Pmcixufav Dl Rwenhvxjqaol Lisbon Portugal
Rzhqykdidxyo sazbtt Brno-Sever Czechia
Aehdlmz Oiczfsirqvk Ocyigr Mhezwuusbq Da Tcilmd Turin Italy
Sqhvpvt Sjogxkqjtsgdhgx Nt I W Bbfbvqf Sdylb Bytom Poland
Alhypay Suhuwbukd Lrghkq Nfvwsr 1 Chnfqa Naples Italy
Htfjyujq Uoxzjqlunxfgm Hzohohfr Tnhpd y Pdqdxv Iaksjjdi Cwbevj dtklficnzsmwlqczp (cyqf Badalona Spain

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
21.05.2024
Czechia Czechia
Recruiting
21.05.2024
France France
Recruiting
21.05.2024
Germany Germany
Recruiting
21.05.2024
Hungary Hungary
Recruiting
21.05.2024
Italy Italy
Recruiting
21.05.2024
Poland Poland
Recruiting
21.05.2024
Portugal Portugal
Recruiting
21.05.2024
Romania Romania
Recruiting
21.05.2024
Slovakia Slovakia
Recruiting
21.05.2024
Spain Spain
Recruiting
21.05.2024

Trial locations

Ianalumab is a medication being studied for its long-term safety and tolerability in patients with systemic lupus erythematosus (SLE). It is administered as an injection under the skin, either once a month or once every three months. The study aims to understand how well patients tolerate this medication over an extended period.

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. SLE is characterized by periods of illness, called flares, and periods of wellness, or remission. The severity and progression of the disease can vary widely among individuals. Over time, SLE can lead to damage in the affected organs and tissues.

Trial ID:
2023-505929-14-00
Protocol code:
VAY736F12301E1
NCT ID:
NCT06133972
Trial Phase:
Therapeutic confirmatory (Phase III)

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