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Taking people in ColombiaPhase 3

Checks long-term safety of ianalumab in people with lupus

Tests ianalumab against placebo for long-term safety in people with lupus.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Barranquilla, Bogota, Bucaramanga, Cali, Chía, and Medellín, ColombiaSee the 6 sitesAlso in 28 other countries, 164 sites
Registry title
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Status
Recruiting
Phase
Phase 3
People taking part
550 people, planned
Started
21 May 2024
Expected to end
2 Oct 2034
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Placebo
  • Ianalumab
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with systemic lupus erythematosus who finished the treatment period of one of the two SIRIUS-SLE core studies. It checks long-term safety of ianalumab.

Age
12 Years to 100 Years
Sex
All sexes can join.
Earlier treatment
Must have taken part in SIRIUS-SLE core study CVAY736F12301 or CVAY736F12302. Must have completed the treatment period through Week 60 without stopping treatment.

Main reasons for not taking part

  • Use of prohibited therapies
  • Active infection needing intravenous or intramuscular treatment that puts the person at risk
  • Plans for live vaccines during the study
  • Pregnant or nursing (breastfeeding) women

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Use of prohibited therapies
  • Plans for administration of live vaccines during the study period
  • 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
  • Pregnant or nursing (lactating) women; Other protocol-defined inclusion/exclusion criteria may apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 12 and 100 years old?

Where in Colombia

Also in 28 other countries, 164 sites

  • Barranquilla, AtlánticoHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Bogota, CundinamarcaHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Bucaramanga, Santander DepartmentHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Cali, Valle del Cauca DepartmentHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • Chía, CundinamarcaHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • MedellínHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • Ianalumab monthlyTreatment being tested

    Ianalumab s.c. monthly

    Treatment: Ianalumab

  • Ianalumab quarterlyTreatment being tested

    Ianalumab s.c. quarterly

    Treatment: Ianalumab

  • Placebo monthlyPlacebo, for comparison

    Placebo s.c. monthly

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)
Plain-language title
Checks long-term safety of ianalumab in people with lupusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06133972, who can take part
Record updated
9 November 2026