RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2024-05-21
Study Completion:2031-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06133972

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.
  1. * Use of prohibited therapies.
  2. * 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.
  3. * Plans for administration of live vaccines during the study period.
  4. * Pregnant or nursing (lactating) women.
  5. * 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).
  6. * 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.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111
novartis.email@novartis.com

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Pinnacle Research Group Llc .
Anniston, Alabama, 36207
United States
Clinical Res Of W Florida
Clearwater, Florida, 33765
United States
West Tennessee Research Institute
Jackson, Tennessee, 38305
United States
Shelby Research LLC
Memphis, Tennessee, 38119
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-21
Study Completion Date2031-12-23

Study Record Updates

Study Start Date2024-05-21
Study Completion Date2031-12-23

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus