NCT06133972RecruitingPhase 3
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (estimated)
- First submitted
- 2 Oct 2023
- Start date
- 21 May 2024
- Primary completion date
- 3 Apr 2034
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Lupus (SLE)
- NCT number
- NCT06133972
- EU CT number
- 2023-505929-14-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 550
- From 21 May 2024 to the primary completion date, 3 Apr 2034
- 167 sites in 29 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of prohibited therapies.
- Plans for administration of live vaccines during the study period.
Other illness
- Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
Other
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply.
Who the study is looking for
- Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
- Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
- In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.
Age in the registry: 12 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (167)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | CABA | Argentina | Active, not recruiting |
| - Coordinator of this site? Confirm its status | La Plata | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | Quilmes | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | San Miguel | Argentina | Active, not recruiting |
| - Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Maroochydore | Australia | Recruiting |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| - Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Niterói | Brazil | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Vitória | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Rimouski | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Vancouver | Canada | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| - Coordinator of this site? Confirm its status | Valdivia | Chile | Recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| - Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Linyi | China | Recruiting |
| - Coordinator of this site? Confirm its status | Nanchang | China | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| - Coordinator of this site? Confirm its status | Pingxiang | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shantou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| - Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Xinxiang | China | Recruiting |
| - Coordinator of this site? Confirm its status | Barranquilla | Colombia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Bogota | Colombia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Bucaramanga | Colombia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Cali | Colombia | Recruiting |
| - Coordinator of this site? Confirm its status | Chía | Colombia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Medellín | Colombia | Active, not recruiting |
| Revmatologie s.r.o. Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Recruiting |
| Revmatologicky Ustav Coordinator of this site? Confirm its status | Prague 2 | Czechia | Recruiting |
| MEDICAL PLUS s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Recruiting |
| Hospital Universitario De Canarias Coordinator of this site? Confirm its status | La Laguna | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Infanta Sofia Coordinator of this site? Confirm its status | San Sebastián de los Reyes | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Complexo Hospitalario Universitario De Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Hospital Universitario Araba Coordinator of this site? Confirm its status | Vitoria | Spain | Recruiting |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Recruiting |
| - Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Recruiting |
| Qualiclinic Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Recruiting |
| Vita Verum Medical Bt. Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Recruiting |
| Belvárosi Egészségház Kft. Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Recruiting |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Ahmedabad | India | Recruiting |
| - Coordinator of this site? Confirm its status | Kolhāpur | India | Recruiting |
| - Coordinator of this site? Confirm its status | Kozhikode | India | Recruiting |
| - Coordinator of this site? Confirm its status | Nagpur | India | Recruiting |
| - Coordinator of this site? Confirm its status | Nashik | India | Recruiting |
| - Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
| - Coordinator of this site? Confirm its status | Pune | India | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Ospedaliera Sant'Anna E San Sebastiano Di Caserta Coordinator of this site? Confirm its status | Caserta | Italy | Recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Sanitaria Locale Napoli 1 Centro Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| San Camillo Forlanini Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Bunkyo Ku | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Fuchū | Japan | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Nagoya | Japan | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Sapporo | Japan | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Shinjuku Ku | Japan | Active, not recruiting |
| - Coordinator of this site? Confirm its status | tabashi City | Japan | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Yokohama | Japan | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Guadalajara | Mexico | Active, not recruiting |
| - Coordinator of this site? Confirm its status | León | Mexico | Recruiting |
| - Coordinator of this site? Confirm its status | Mérida | Mexico | Recruiting |
| - Coordinator of this site? Confirm its status | México | Mexico | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Morelia | Mexico | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Ipoh | Malaysia | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Szpital Specjalistyczny Nr I W Bytomiu SPZOZ Coordinator of this site? Confirm its status | Bytom | Poland | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local De Saude Da Regiao De Leiria E.P.E. Coordinator of this site? Confirm its status | Leiria | Portugal | Recruiting |
| Instituto Portugues de Reumatologia Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Centro Hospitalar Universitario De Lisboa Norte E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
| Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Saint Maria Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Artromac n.o. Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| Zazabie s.r.o. Coordinator of this site? Confirm its status | Kosice - Stare Mesto | Slovakia | Recruiting |
| Univerzitna nemocnica Nemocnica svaeteho Michala a.s. Coordinator of this site? Confirm its status | Stare Mesto | Slovakia | Recruiting |
| - Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| - Coordinator of this site? Confirm its status | Muang | Thailand | Recruiting |
| - Coordinator of this site? Confirm its status | Songkhla | Thailand | Recruiting |
| - Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| - Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Pinnacle Research Group, LLC Coordinator of this site? Confirm its status | Anniston | United States | Recruiting |
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Maryland Coordinator of this site? Confirm its status | Baltimore | United States | Active, not recruiting |
| Novel Research LLC Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Providence Medical Center Coordinator of this site? Confirm its status | Burbank | United States | Recruiting |
| Clinical Res Of W Florida Coordinator of this site? Confirm its status | Clearwater | United States | Recruiting |
| GNP Research Coordinator of this site? Confirm its status | Cooper City | United States | Recruiting |
| Henry Ford Health Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Ahmed Arif Medical Research Center Coordinator of this site? Confirm its status | Grand Blanc | United States | Recruiting |
| Homestead Assoc In Research Inc Coordinator of this site? Confirm its status | Homestead | United States | Recruiting |
| West Tennessee Research Institute Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Accurate Clinical Research Coordinator of this site? Confirm its status | Lake Charles | United States | Recruiting |
| Advanced Medical Research Coordinator of this site? Confirm its status | La Palma | United States | Recruiting |
| Parris and Associates Rheumatology Coordinator of this site? Confirm its status | Lawrenceville | United States | Recruiting |
| Accurate Clinical Research Coordinator of this site? Confirm its status | League City | United States | Recruiting |
| Shelby Research LLC Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Paramount Med Rsrch and Consult LLC Coordinator of this site? Confirm its status | Middleburg Heights | United States | Recruiting |
| UMC New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Active, not recruiting |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| IRIS Research and Development Coordinator of this site? Confirm its status | Plantation | United States | Recruiting |
| Epic Medical Research Coordinator of this site? Confirm its status | Red Oak | United States | Recruiting |
| Robert A Hozman MD SC Coordinator of this site? Confirm its status | Skokie | United States | Completed |
| Clinical Research of West Florida Inc Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Millennium Clinical Trials Coordinator of this site? Confirm its status | Westlake Village | United States | Active, not recruiting |
| Willow Rheumatology Wellness Coordinator of this site? Confirm its status | Willowbrook | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Pretoria | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Somerset West | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Umhlanga | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.