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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06133972
Registration number
NCT06133972
Ethics application status
Date submitted
2/10/2023
Date registered
18/11/2023
Date last updated
29/06/2025
Titles & IDs
Public title
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
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Scientific title
A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)
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Secondary ID [1]
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2023-505929-14-00
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Secondary ID [2]
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CVAY736F12301E1
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Universal Trial Number (UTN)
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Trial acronym
SIRIUS-SLE LTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ianalumab
Experimental: Ianalumab monthly - Ianalumab s.c. monthly
Experimental: Ianalumab quarterly - Ianalumab s.c. quarterly
Placebo comparator: Placebo monthly - Placebo s.c. monthly
Treatment: Drugs: Placebo
Placebo s.c. monthly
Treatment: Drugs: Ianalumab
Ianalumab s.c. monthly Ianalumab s.c. quarterly
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of treatment-emergent Adverse events/Serious Adverse events
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Assessment method [1]
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Assessment of long-term safety and tolerability of ianalumab
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Timepoint [1]
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through study completion, up to approximately 91 months
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Secondary outcome [1]
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Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response
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Assessment method [1]
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SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of = 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as = 1 new A or = 2 new B items compared to baseline * No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of = 0.3 from baseline on a 0 to 3 visual analog scale
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Timepoint [1]
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up to Week 216
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Secondary outcome [2]
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Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
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Assessment method [2]
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SLICC/ACR Damage Index is a measure of cumulative damage due to SLE
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Timepoint [2]
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up to Week 216
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Secondary outcome [3]
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Average daily dose of oral corticosteroids administered
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Assessment method [3]
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Evaluating the effect of ianalumab on corticosteroids intake
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Timepoint [3]
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up to Week 216
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Secondary outcome [4]
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Annualized BILAG moderate or severe flare rate
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Assessment method [4]
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Annualized BILAG moderate or severe flare rate where moderate BILAG flare is defined as 2 or more new BILAG-2004 B items, and severe BILAG flare is defined as 1 or more new BILAG-2004 A items, compared to the previous visit
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Timepoint [4]
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up to Week 216
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Eligibility
Key inclusion criteria
Key
* 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.
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Minimum age
12
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Maximum age
100
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/05/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/12/2031
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Actual
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Sample size
Target
550
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Novartis Investigative Site - Maroochydore
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Recruitment postcode(s) [1]
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4558 - Maroochydore
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Florida
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Louisiana
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Michigan
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Tennessee
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Argentina
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Buenos Aires
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Argentina
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Tucuman
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Brazil
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BA
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Brazil
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Sao Paulo
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Bulgaria
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Plovdiv
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Quebec
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China
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Guangdong
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China
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Jiangxi
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China
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Jilin
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China
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Shandong
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China
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Xinjiang
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China
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Beijing
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China
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Shanghai
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China
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Zhejiang
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Colombia
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Antioquia
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Brno
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Uherske Hradiste
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Montpellier 5
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Paris
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Ramat Gan
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Aichi
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Japan
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Seocho Gu
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Distrito Federal
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Bytom
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Warszawa
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Braga
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Romania
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Brasov
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Romania
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Cluj Napoca
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Catalunya
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Galicia
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Madrid
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Thailand
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT06133972
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Country
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Phone
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1-888-669-6682
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06133972
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