Recruiting

Phase 3

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06133972

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

Ianalumab

Study Details

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

Study ID

NCT06133972

Start date

May 21, 2024

Status verified date

Jul, 2026

Completion date

Apr 5, 2032

Anticipated

Primary completion date

Apr 8, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Key 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.

Key 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ianalumab monthly

Ianalumab s.c. monthly

experimental: Ianalumab quarterly

Ianalumab s.c. quarterly

placebo comparator: Placebo monthly

Placebo s.c. monthly

Interventions

Placebo

Placebo s.c. monthly

Ianalumab

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

Primary outcome measure

Number of treatment-emergent Adverse events/Serious Adverse events [ Time Frame: through study completion, up to approximately 91 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

Locations

Pinnacle Research Group Llc

Recruiting

Anniston, Alabama, United States, 36207

Contacts

Ruby Fields

256-236-0055 rfields@pinnacletrials.com

Principal Investigator:

Vishala L Chindalore

Providence Medical Center

Recruiting

Burbank, California, United States, 91505

Contacts

Sandra Figueroa

818-869-7067 Sandra.Figueroa@providence.org

Principal Investigator:

Sue Chung

Advanced Medical Research

Recruiting

La Palma, California, United States, 90623

Contacts

Alejandro Merazo

714-752-6587 amerazo@advmedresearch.com

Principal Investigator:

Gerald Ho

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Chong Pedrick

chong.pedrick@cuanschutz.edu

Principal Investigator:

Christopher Striebich

Clinical Res Of W Florida

Recruiting

Clearwater, Florida, United States, 33765

Contacts

Jessica Mayfield

727-466-0078 JMayfield@crwf.com

Principal Investigator:

Robert Levin

GNP Research

Recruiting

Cooper City, Florida, United States, 33024

Contacts

Melissa Pierce

754-248-3589 melissa@gnpresearch.com

Principal Investigator:

Mark Jaffe

IRIS Research and Development

Recruiting

Plantation, Florida, United States, 33324

Contacts

Jhon Galindo

954-476-2338 jgalindo@irisrheumatology.com

Principal Investigator:

Guillermo Valenzuela

Clinical Research of West Florida Inc

Recruiting

Tampa, Florida, United States, 33603

Contacts

Abby Carlson

813-870-1292 ACarlson@crwf.com

Principal Investigator:

John Carter

Parris and Associates Rheumatology

Recruiting

Lawrenceville, Georgia, United States, 30044

Contacts

Mannai Coutermarsh

+17709621616#8334 m.coutermarsh@parrisandassociates.net

Principal Investigator:

Glenn Parris

Robert A Hozman MD SC

Recruiting

Skokie, Illinois, United States, 60076

Contacts

Patrycja Kalwajtys

847-727-2743 pkalwajtys@cisresearch.com

Principal Investigator:

Robert Hozman

Willow Rheumatology Wellness

Recruiting

Willowbrook, Illinois, United States, 60527

Contacts

Lubna Ali

lali@willowrheum.com

Principal Investigator:

Angela R Crowley

Accurate Clinical Research

Recruiting

Lake Charles, Louisiana, United States, 70601

Contacts

Machell Broussard

mbroussard@accurateclinicalresearch.com

Principal Investigator:

Enrique Mendez

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Jenna Hudy

313-916-1984 jhudy1@hfhs.org

Principal Investigator:

Alireza Meysami

Ahmed Arif Medical Research Center

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Iman Abdelrahman

810-953-8700 iman@aamrc.net

Principal Investigator:

Ali Karrar

Paramount Med Rsrch and Consult LLC

Recruiting

Middleburg Heights, Ohio, United States, 44130

Contacts

Denine Ryan

440-891-9395 deniner64@gmail.com

Principal Investigator:

Isam Diab

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Abbie Hinton

731-633-0119 ahinton@arthritisclinic.org

Principal Investigator:

Jacob A Aelion

Shelby Research LLC

Recruiting

Memphis, Tennessee, United States, 38121

Contacts

Suvarna Konangula

901-681-9670 shelbyres1999@outlook.com

Principal Investigator:

Ramesh C Gupta

Accurate Clinical Research

Recruiting

League City, Texas, United States, 77573

Contacts

Mariela Martinez

mmartinez@accurateclinicalresearch.com

Principal Investigator:

Sabeen Najam

Epic Medical Research

Recruiting

Red Oak, Texas, United States, 75154

Contacts

Harshini Potluri

469-206-2642 hpotluri@epicmedresearch.com

Principal Investigator:

Sunny Patel

Novartis Investigative Site

Recruiting

Rimouski, Quebec, Canada, G5L 5T1

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-08.