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

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
CHU Grenoble Alpes La Tronche France
Zazabie s.r.o. Kosice Slovakia
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Saint Maria Hospital Bucharest Romania
Hospital Del Mar Barcelona Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
San Camillo Forlanini Hospital Rome Italy
Vita Verum Medical Bt. Szekesfehervar Hungary
Hospital Universitario Rio Hortega Valladolid Spain
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Qualiclinic Kft. Budapest Hungary
Instituto Portugues De Reumatologia Lisbon Portugal
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ Bytom Poland
Medical Plus s.r.o. Uherske Hradiste Czechia
Hospital Universitario Infanta Sofía San Sebastian De Los Reyes Spain
Narodny Ustav Reumatickych Chorob Piestany Slovakia
Azienda Ospedaliera di Padova Padua Italy
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Universita’ Di Pisa Pisa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Hospital Universitario Araba Vitoria Spain
Belvarosi Egeszseghaz Kft. Zalaegerszeg Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta Caserta Italy
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Wroclaw Poland
Hospital Universitario De Canarias La Laguna Spain
Hopital Beaujon Clichy France
Universita’ Degli Studi Di Ferrara Ferrara Italy
Mxbhudxfk Iqvdwleodb Cmjvemvn Sbmphbjf Seu z oteu Warsaw Poland
Hyonuoft Ufeclxmevrzry Mxiibdi Dy Vbejjychim Santander Spain
Cueluzy Mgtrkdq Dl Daetcbhskg Sv Tnmbllyiv Ahtlewaji Nyzkdu Sbmwfu Brasov Romania
Cjwoovxp Hurrhbotwvxr Uplxgjngvtbbh Dj Vyqu Vigo Spain
Ryqmnpbbddti sigvso Brno-Sever Czechia
Ubqcvgaswal nnyaqepoh &cazgdi Nucsxmeeg scgjexs Mnqhyfkc ak s Bratislava Slovakia
Uqhmodwneg Hpfhhhaz Cdgjxcw Cologne Germany
Cwxpxf Haqmgdhnmda Rjenjhfb Uibcrnyoornty Dn Ttrtk Tours France
Cgkowr Huoaqckrmml Rccfnuhm Drtwvamphtthqj Angers France
Hqdqfafc Uijrkgoftiekk Hnypldhc Topeb y Pviakj Ihunzhce Cclcew dtppnrblyjfxpjhjb (kdad Badalona Spain
Hvdbjghr Vvek ddwlgxib Barcelona 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
Not yet 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.

Investigated diseases:

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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