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Recruiting NCT06133972

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

Phase III Interventional Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Ianalumab.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 12 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Brazil, Bulgaria +24
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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).

Detailed description

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.

Interventions

  • Drug Placebo
    Placebo s.c. monthly
  • Drug Ianalumab
    Ianalumab s.c. monthly Ianalumab s.c. quarterly

Primary outcome measures

  • Number of treatment-emergent Adverse events/Serious Adverse events [Time frame: through study completion, up to approximately 91 months]
Secondary outcome measures (4)
  • Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response [Time frame: up to Week 216]
  • Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index [Time frame: up to Week 216]
  • Average daily dose of oral corticosteroids administered [Time frame: up to Week 216]
  • Annualized BILAG moderate or severe flare rate [Time frame: up to Week 216]

Eligibility criteria

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.

Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 22 centers
  • Pinnacle Research Group Llc — Anniston
  • Providence Medical Center — Burbank
  • Advanced Medical Research — La Palma
  • Millennium Clinical Trials — Westlake Village
  • University of Colorado Denver — Aurora
  • Clinical Res Of W Florida — Clearwater
  • GNP Research — Cooper City
  • IRIS Research and Development — Plantation
  • … and 14 more centers
China · 15 centers
  • Novartis Investigative Site — Guangzhou
  • Novartis Investigative Site — Shantou
  • Novartis Investigative Site — Nanjing
  • Novartis Investigative Site — Suzhou
  • Novartis Investigative Site — Nanchang
  • Novartis Investigative Site — Pingxiang
  • Novartis Investigative Site — Changchun
  • Novartis Investigative Site — Linyi
  • … and 7 more centers
India · 9 centers

Center list to be confirmed — check the primary protocol.

Brazil · 8 centers
  • Novartis Investigative Site — Salvador
  • Novartis Investigative Site — Belo Horizonte
  • Novartis Investigative Site — Niterói
  • Novartis Investigative Site — Rio de Janeiro
  • Novartis Investigative Site — Barretos
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — Salvador
Japan · 8 centers

Center list to be confirmed — check the primary protocol.

Spain · 8 centers

Center list to be confirmed — check the primary protocol.

Argentina · 7 centers
  • Novartis Investigative Site — La Plata
  • Novartis Investigative Site — Quilmes
  • Novartis Investigative Site — San Miguel
  • Novartis Investigative Site — San Miguel
  • Novartis Investigative Site — Caba
  • Novartis Investigative Site — Caba
  • Novartis Investigative Site — San Miguel de Tucumán
Colombia · 6 centers
  • Novartis Investigative Site — Medellín
  • Novartis Investigative Site — Barranquilla
  • Novartis Investigative Site — Chía
  • Novartis Investigative Site — Bucaramanga
  • Novartis Investigative Site — Cali
  • Novartis Investigative Site — Bogotá
Mexico · 6 centers

Center list to be confirmed — check the primary protocol.

Poland · 6 centers

Center list to be confirmed — check the primary protocol.

France · 5 centers
  • Novartis Investigative Site — Montpellier
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Toulouse
  • Novartis Investigative Site — Toulouse
South Africa · 5 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 5 centers

Center list to be confirmed — check the primary protocol.

Chile · 3 centers
  • Novartis Investigative Site — Valdivia
  • Novartis Investigative Site — Santiago
  • Novartis Investigative Site — Santiago
Czechia · 3 centers
  • Novartis Investigative Site — Brno
  • Novartis Investigative Site — Prague
  • Novartis Investigative Site — Uherské Hradiště
Hungary · 3 centers
  • Novartis Investigative Site — Székesfehérvár
  • Novartis Investigative Site — Gyula
  • Novartis Investigative Site — Zalaegerszeg
Romania · 3 centers

Center list to be confirmed — check the primary protocol.

South Korea · 3 centers

Center list to be confirmed — check the primary protocol.

Bulgaria · 2 centers
  • Novartis Investigative Site — Plovdiv
  • Novartis Investigative Site — Sofia
Canada · 2 centers
  • Novartis Investigative Site — Vancouver
  • Novartis Investigative Site — Rimouski
Germany · 2 centers
  • Novartis Investigative Site — Cologne
  • Novartis Investigative Site — Leipzig
Israel · 2 centers

Center list to be confirmed — check the primary protocol.

Italy · 2 centers

Center list to be confirmed — check the primary protocol.

Portugal · 2 centers

Center list to be confirmed — check the primary protocol.

Thailand · 2 centers

Center list to be confirmed — check the primary protocol.

Australia · 1 center
  • Novartis Investigative Site — Maroochydore
Guatemala · 1 center
  • Novartis Investigative Site — Guatemala City
Malaysia · 1 center

Center list to be confirmed — check the primary protocol.

Slovakia · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06133972 · CVAY736F12301E1 · 2023-505929-14-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗