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Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

NCT ID: NCT06133972

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2032-04-16

Brief Summary

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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).

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Detailed Description

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The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial is designed to evaluate long-term safety, tolerability and efficacy of two regimen of ianalumab versus placebo, given as monthly or quarterly subcutaneous (s.c.) injection
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ianalumab monthly

Ianalumab s.c. monthly

Group Type EXPERIMENTAL

Ianalumab

Intervention Type DRUG

Ianalumab s.c. monthly Ianalumab s.c. quarterly

Ianalumab quarterly

Ianalumab s.c. quarterly

Group Type EXPERIMENTAL

Ianalumab

Intervention Type DRUG

Ianalumab s.c. monthly Ianalumab s.c. quarterly

Placebo monthly

Placebo s.c. monthly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo s.c. monthly

Interventions

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Placebo

Placebo s.c. monthly

Intervention Type DRUG

Ianalumab

Ianalumab s.c. monthly Ianalumab s.c. quarterly

Intervention Type DRUG

Other Intervention Names

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VAY736

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Use of prohibited therapies.
* 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.
* Plans for administration of live vaccines during the study period.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
* United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.
Minimum Eligible Age

12 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Pinnacle Research Group Llc

Anniston, Alabama, United States

Site Status RECRUITING

Providence Medical Center

Burbank, California, United States

Site Status RECRUITING

Advanced Medical Research

La Palma, California, United States

Site Status RECRUITING

Millennium Clinical Trials

Westlake Village, California, United States

Site Status RECRUITING

University of Colorado Denver

Aurora, Colorado, United States

Site Status RECRUITING

Clinical Res Of W Florida

Clearwater, Florida, United States

Site Status RECRUITING

GNP Research

Cooper City, Florida, United States

Site Status RECRUITING

IRIS Research and Development

Plantation, Florida, United States

Site Status RECRUITING

Willow Rheumatology Wellness

Willowbrook, Illinois, United States

Site Status RECRUITING

Accurate Clinical Research

Lake Charles, Louisiana, United States

Site Status RECRUITING

Henry Ford Health

Detroit, Michigan, United States

Site Status RECRUITING

Ahmed Arif Medical Research Center

Grand Blanc, Michigan, United States

Site Status RECRUITING

Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio, United States

Site Status RECRUITING

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status RECRUITING

Shelby Research LLC

Memphis, Tennessee, United States

Site Status RECRUITING

Novel Research LLC

Bellaire, Texas, United States

Site Status RECRUITING

Accurate Clinical Research

League City, Texas, United States

Site Status RECRUITING

Novartis Investigative Site

San Miguel, Buenos Aires, Argentina

Site Status RECRUITING

Novartis Investigative Site

San Miguel, Tucumán Province, Argentina

Site Status RECRUITING

Novartis Investigative Site

Caba, , Argentina

Site Status RECRUITING

Novartis Investigative Site

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

Novartis Investigative Site

Maroochydore, Queensland, Australia

Site Status RECRUITING

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Novartis Investigative Site

Barretos, São Paulo, Brazil

Site Status RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Novartis Investigative Site

Salvador, , Brazil

Site Status RECRUITING

Novartis Investigative Site

Plovdiv, , Bulgaria

Site Status RECRUITING

Novartis Investigative Site

Vancouver, British Columbia, Canada

Site Status RECRUITING

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Rimouski, Quebec, Canada

Site Status RECRUITING

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Valdivia, Los Ríos Region, Chile

Site Status RECRUITING

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Santiago, RM, Chile

Site Status RECRUITING

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Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

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Guangzhou, Guangdong, China

Site Status RECRUITING

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Shantou, Guangdong, China

Site Status RECRUITING

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Nanjing, Jiangsu, China

Site Status RECRUITING

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Suzhou, Jiangsu, China

Site Status RECRUITING

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Nanchang, Jiangxi, China

Site Status RECRUITING

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Pingxiang, Jiangxi, China

Site Status RECRUITING

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Changchun, Jilin, China

Site Status RECRUITING

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Linyi, Shandong, China

Site Status RECRUITING

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Ürümqi, Xinjiang, China

Site Status RECRUITING

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Ningbo, Zhejiang, China

Site Status RECRUITING

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Beijing, , China

Site Status RECRUITING

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Beijing, , China

Site Status RECRUITING

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Shanghai, , China

Site Status RECRUITING

Novartis Investigative Site

Medellín, Antioquia, Colombia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Site Status RECRUITING

Novartis Investigative Site

Chía, Cundinamarca, Colombia

Site Status RECRUITING

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Bucaramanga, Santander Department, Colombia

Site Status RECRUITING

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Bogotá, , Colombia

Site Status RECRUITING

Novartis Investigative Site

Brno, , Czechia

Site Status RECRUITING

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Uherské Hradiště, , Czechia

Site Status RECRUITING

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Montpellier, , France

Site Status RECRUITING

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Paris, , France

Site Status RECRUITING

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Paris, , France

Site Status RECRUITING

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Toulouse, , France

Site Status RECRUITING

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Toulouse, , France

Site Status RECRUITING

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Leipzig, Saxony, Germany

Site Status RECRUITING

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Guatemala City, , Guatemala

Site Status RECRUITING

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Székesfehérvár, Fejér, Hungary

Site Status RECRUITING

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Gyula, , Hungary

Site Status RECRUITING

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Ahmedabad, Gujarat, India

Site Status RECRUITING

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Kozhikode, Kerala, India

Site Status RECRUITING

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Nagpur, Maharashtra, India

Site Status RECRUITING

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Pune, Maharashtra, India

Site Status RECRUITING

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New Delhi, , India

Site Status RECRUITING

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Haifa, , Israel

Site Status RECRUITING

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Ramat Gan, , Israel

Site Status RECRUITING

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Torino, TO, Italy

Site Status RECRUITING

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Nagoya, Aichi-ken, Japan

Site Status RECRUITING

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Sapporo, Hokkaido, Japan

Site Status RECRUITING

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Chuo Ku, Tokyo, Japan

Site Status RECRUITING

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Ipoh, Perak, Malaysia

Site Status RECRUITING

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León, Guanajuato, Mexico

Site Status RECRUITING

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Guadalajara, Jalisco, Mexico

Site Status RECRUITING

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Mexico City, Mexico City, Mexico

Site Status RECRUITING

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Morelia, Michoacán, Mexico

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Mérida, Yucatán, Mexico

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México, , Mexico

Site Status RECRUITING

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Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

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Bydgoszcz, , Poland

Site Status RECRUITING

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Bydgoszcz, , Poland

Site Status RECRUITING

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Bytom, , Poland

Site Status RECRUITING

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Warsaw, , Poland

Site Status RECRUITING

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Warsaw, , Poland

Site Status RECRUITING

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Braga, , Portugal

Site Status RECRUITING

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Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

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Brasov, , Romania

Site Status RECRUITING

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Bucharest, , Romania

Site Status RECRUITING

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Cape Town, Western Cape, South Africa

Site Status RECRUITING

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Cape Town, Western Cape, South Africa

Site Status RECRUITING

Novartis Investigative Site

Gwangju Gwangyeoksi, Gwangju, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

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Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Site Status RECRUITING

Novartis Investigative Site

Badalona, Barcelona, Spain

Site Status RECRUITING

Novartis Investigative Site

Santander, Cantabria, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status RECRUITING

Novartis Investigative Site

San Sebastian Reyes, Madrid, Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Taichung, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Taichung, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Taipei, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Taoyuan District, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Bangkok, , Thailand

Site Status RECRUITING

Countries

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United States Argentina Australia Brazil Bulgaria Canada Chile China Colombia Czechia France Germany Guatemala Hungary India Israel Italy Japan Malaysia Mexico Poland Portugal Romania South Africa South Korea Spain Taiwan Thailand

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

[email protected]
1-888-669-6682

Novartis Pharmaceuticals

Role: CONTACT

[email protected]
+41613241111

Facility Contacts

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Jamie Bush

Role: primary

[email protected]
256-236-0055

Jeffrey Figueroa

Role: primary

[email protected]
818-869-7067

Milagros Romero

Role: primary

[email protected]
562-867-8195

Jasmine Medina

Role: primary

[email protected]

Panida Khuansanguan

Role: primary

[email protected]

Bridget Ben-Hayon

Role: primary

[email protected]
727-466-0078

Mariana Alvarado

Role: primary

[email protected]
754-248-3538

Jhon Galindo

Role: primary

[email protected]
954-476-2338

Avni Singh

Role: primary

[email protected]

Machell Broussard

Role: primary

[email protected]

Marie Melville

Role: primary

[email protected]

Aya Elbakheet

Role: primary

[email protected]
810-953-8700

Denine Ryan

Role: primary

[email protected]
440-891-9395

Rachel Williams

Role: primary

[email protected]
731-664-7824

Bhanu Prathap Gaddam

Role: primary

[email protected]
+1 901 681 9670

Hina Arshad

Role: primary

[email protected]

David Batista

Role: primary

[email protected]

Other Identifiers

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2023-505929-14-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CVAY736F12301E1

Identifier Type: -

Identifier Source: org_study_id

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