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

NCT06133972 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CVAY736F12301E12023-505929-14-00
• Study Type: interventional
• Target: 550
• Locations: 28 countries
• Sites: 127

Brief Summary

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).

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; SLE; B cell depletion; SLEDAI-2K; BILAG-2004; SRI-4, ANA; ianalumab; VAY736

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent Adverse events/Serious Adverse events

  Assessment of long-term safety and tolerability of ianalumab

  through study completion, up to approximately 91 months

Secondary Outcomes (4)

• Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response

  up to Week 216

• Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index

  up to Week 216

• Average daily dose of oral corticosteroids administered

  up to Week 216

• Annualized BILAG moderate or severe flare rate

  up to Week 216

Study Arms (3)

Ianalumab monthly

EXPERIMENTAL

Ianalumab s.c. monthly

Drug: Ianalumab

Ianalumab quarterly

EXPERIMENTAL

Ianalumab s.c. quarterly

Drug: Ianalumab

Placebo monthly

PLACEBO COMPARATOR

Placebo s.c. monthly

Drug: Placebo

Interventions

Placebo DRUG

Placebo s.c. monthly

Placebo monthly

Ianalumab DRUG

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

Also known as: VAY736

Ianalumab monthly; Ianalumab quarterly

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (127)

Pinnacle Research Group Llc

Anniston, Alabama, 36207, United States

RECRUITING

Providence Medical Center

Burbank, California, 91505, United States

RECRUITING

Advanced Medical Research

La Palma, California, 90623, United States

RECRUITING

Millennium Clinical Trials

Westlake Village, California, 91361, United States

RECRUITING

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Clinical Res Of W Florida

Clearwater, Florida, 33765, United States

RECRUITING

GNP Research

Cooper City, Florida, 33024, United States

RECRUITING

IRIS Research and Development

Plantation, Florida, 33324, United States

RECRUITING

Parris and Associates Rheumatology

Lawrenceville, Georgia, 30044, United States

RECRUITING

Robert A Hozman MD SC

Skokie, Illinois, 60076, United States

RECRUITING

Willow Rheumatology Wellness

Willowbrook, Illinois, 60527, United States

RECRUITING

Accurate Clinical Research

Lake Charles, Louisiana, 70601, United States

RECRUITING

University Of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Ahmed Arif Medical Research Center

Grand Blanc, Michigan, 48439, United States

RECRUITING

Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio, 44130, United States

RECRUITING

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

RECRUITING

Shelby Research LLC

Memphis, Tennessee, 38119, United States

RECRUITING

Novel Research LLC

Bellaire, Texas, 77401, United States

RECRUITING

Accurate Clinical Research

League City, Texas, 77573, United States

RECRUITING

Epic Medical Research

Red Oak, Texas, 75154, United States

RECRUITING

Novartis Investigative Site

San Miguel, Buenos Aires, B1663GKT, Argentina

RECRUITING

Novartis Investigative Site

San Miguel, Tucumán Province, T4000CBC, Argentina

RECRUITING

Novartis Investigative Site

Caba, C1015ABO, Argentina

RECRUITING

Novartis Investigative Site

San Miguel de Tucumán, 4000, Argentina

RECRUITING

Novartis Investigative Site

Maroochydore, Queensland, 4558, Australia

RECRUITING

Novartis Investigative Site

Salvador, Estado de Bahia, 40150 150, Brazil

RECRUITING

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30150-221, Brazil

RECRUITING

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 22211-230, Brazil

RECRUITING

Novartis Investigative Site

Barretos, São Paulo, 14784 400, Brazil

RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, 01244-030, Brazil

RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, 04038-002, Brazil

RECRUITING

Novartis Investigative Site

Salvador, 40323-010, Brazil

RECRUITING

Novartis Investigative Site

Plovdiv, 4002, Bulgaria

RECRUITING

Novartis Investigative Site

Sofia, 1431, Bulgaria

RECRUITING

Novartis Investigative Site

Vancouver, British Columbia, V5Z 1L7, Canada

ACTIVE NOT RECRUITING

Novartis Investigative Site

Rimouski, Quebec, G5L 5T1, Canada

RECRUITING

Novartis Investigative Site

Valdivia, Los Ríos Region, 5110683, Chile

RECRUITING

Novartis Investigative Site

Santiago, RM, 7500588, Chile

RECRUITING

Novartis Investigative Site

Santiago, Santiago Metropolitan, 7500710, Chile

RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

RECRUITING

Novartis Investigative Site

Shantou, Guangdong, 515000, China

RECRUITING

Novartis Investigative Site

Nanjing, Jiangsu, 210008, China

RECRUITING

Novartis Investigative Site

Suzhou, Jiangsu, 215004, China

RECRUITING

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

ACTIVE NOT RECRUITING

Novartis Investigative Site

Pingxiang, Jiangxi, 337000, China

RECRUITING

Novartis Investigative Site

Changchun, Jilin, 130021, China

RECRUITING

Novartis Investigative Site

Linyi, Shandong, 276000, China

RECRUITING

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

RECRUITING

Novartis Investigative Site

Ürümqi, Xinjiang, 830001, China

RECRUITING

Novartis Investigative Site

Ningbo, Zhejiang, 315016, China

RECRUITING

Novartis Investigative Site

Beijing, 100069, China

RECRUITING

Novartis Investigative Site

Beijing, 100730, China

RECRUITING

Novartis Investigative Site

Shanghai, 200127, China

RECRUITING

Novartis Investigative Site

Medellín, Antioquia, 050001, Colombia

ACTIVE NOT RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

Novartis Investigative Site

Chía, Cundinamarca, 250001, Colombia

RECRUITING

Novartis Investigative Site

Bucaramanga, Santander Department, 680003, Colombia

RECRUITING

Novartis Investigative Site

Bogotá, 111211, Colombia

RECRUITING

Novartis Investigative Site

Brno, 638 00, Czechia

RECRUITING

Novartis Investigative Site

Prague, 128 00, Czechia

RECRUITING

Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

RECRUITING

Novartis Investigative Site

Montpellier, 34295, France

RECRUITING

Novartis Investigative Site

Paris, 75013, France

RECRUITING

Novartis Investigative Site

Paris, 75014, France

RECRUITING

Novartis Investigative Site

Toulouse, 31054, France

RECRUITING

Novartis Investigative Site

Toulouse, 31059, France

RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

RECRUITING

Novartis Investigative Site

Guatemala City, 01010, Guatemala

RECRUITING

Novartis Investigative Site

Székesfehérvár, Fejér, 8000, Hungary

RECRUITING

Novartis Investigative Site

Gyula, 5700, Hungary

RECRUITING

Novartis Investigative Site

Ahmedabad, Gujarat, 380006, India

RECRUITING

Novartis Investigative Site

Ahmedabad, Gujarat, 380015, India

RECRUITING

Novartis Investigative Site

Kozhikode, Kerala, 673008, India

RECRUITING

Novartis Investigative Site

Nagpur, Maharashtra, 441108, India

RECRUITING

Novartis Investigative Site

Nashik, Maharashtra, 422101, India

RECRUITING

Novartis Investigative Site

Pune, Maharashtra, 411001, India

RECRUITING

Novartis Investigative Site

New Delhi, 110029, India

RECRUITING

Novartis Investigative Site

New Delhi, 110075, India

RECRUITING

Novartis Investigative Site

Haifa, 3109601, Israel

ACTIVE NOT RECRUITING

Novartis Investigative Site

Ramat Gan, 5265601, Israel

RECRUITING

Novartis Investigative Site

Pisa, PI, 56126, Italy

RECRUITING

Novartis Investigative Site

Torino, TO, 10128, Italy

RECRUITING

Novartis Investigative Site

Nagoya, Aichi-ken, 4578510, Japan

RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, 0608648, Japan

RECRUITING

Novartis Investigative Site

Yokohama, Kanagawa-ku, 236-0004, Japan

RECRUITING

Novartis Investigative Site

Chuo Ku, Tokyo, 1048560, Japan

RECRUITING

Novartis Investigative Site

Ipoh, Perak, 30450, Malaysia

RECRUITING

Novartis Investigative Site

León, Guanajuato, 37160, Mexico

RECRUITING

Novartis Investigative Site

Guadalajara, Jalisco, 44160, Mexico

RECRUITING

Novartis Investigative Site

Mexico City, Mexico City, 06700, Mexico

RECRUITING

Novartis Investigative Site

Morelia, Michoacán, 58000, Mexico

RECRUITING

Novartis Investigative Site

Mérida, Yucatán, 97070, Mexico

RECRUITING

Novartis Investigative Site

México, 07760, Mexico

RECRUITING

Novartis Investigative Site

Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

RECRUITING

Novartis Investigative Site

Bydgoszcz, 85-065, Poland

RECRUITING

Novartis Investigative Site

Bydgoszcz, 85-168, Poland

RECRUITING

Novartis Investigative Site

Bytom, 41 902, Poland

RECRUITING

Novartis Investigative Site

Warsaw, 00-874, Poland

RECRUITING

Novartis Investigative Site

Warsaw, 04-141, Poland

RECRUITING

Novartis Investigative Site

Braga, 4710243, Portugal

RECRUITING

Novartis Investigative Site

Cluj-Napoca, Cluj, 400006, Romania

RECRUITING

Novartis Investigative Site

Brasov, 500283, Romania

RECRUITING

Novartis Investigative Site

Bucharest, 011172, Romania

RECRUITING

Novartis Investigative Site

Pretoria, Gauteng, 0002, South Africa

RECRUITING

Novartis Investigative Site

Cape Town, Western Cape, 7405, South Africa

RECRUITING

Novartis Investigative Site

Cape Town, Western Cape, 7500, South Africa

RECRUITING

Novartis Investigative Site

Stellenbosch, Western Cape, 7600, South Africa

RECRUITING

Novartis Investigative Site

Gwangju Gwangyeoksi, Gwangju, 61748, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 04763, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 06591, South Korea

RECRUITING

Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain

RECRUITING

Novartis Investigative Site

Badalona, Barcelona, 08916, Spain

RECRUITING

Novartis Investigative Site

Santander, Cantabria, 39008, Spain

RECRUITING

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

RECRUITING

Novartis Investigative Site

San Sebastian Reyes, Madrid, 28702, Spain

RECRUITING

Novartis Investigative Site

Barcelona, 08035, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28034, Spain

RECRUITING

Novartis Investigative Site

Valencia, 46014, Spain

RECRUITING

Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

RECRUITING

Novartis Investigative Site

Taichung, 40447, Taiwan

RECRUITING

Novartis Investigative Site

Taichung, 407219, Taiwan

RECRUITING

Novartis Investigative Site

Taipei, 11217, Taiwan

RECRUITING

Novartis Investigative Site

Taoyuan District, 33305, Taiwan

RECRUITING

Novartis Investigative Site

Bangkok, 10400, Thailand

RECRUITING

Novartis Investigative Site

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: 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

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: November 18, 2023
• Study Start: May 21, 2024
• Primary Completion (Estimated): April 8, 2030
• Study Completion (Estimated): April 5, 2032
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

MY (1); FR (5); PL (6); KR (3); ES (8); GU (1); TW (5); CL (3); ZA (4); DE (2); ME (6); CO (5); RO (3); TH (2); CA (2); BR (7); IT (2); AU (1); CN (14); HU (2); CZ (3); IN (8); IL (2); PT (1); AR (4); US (21); BU (2); JP (4)