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

Recruiting · NCT06133972 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals

View the official record on ClinicalTrials.gov →

Lupus

Interventions studied

IanalumabPlacebo

What this trial is about

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).

Who can take part

Age range

12 Years to 100 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.
ther protocol-defined inclusion/exclusion criteria may apply.

Where it is running

60 locations listed across 12 US states.

Pinnacle Research Group Llc - Anniston, Alabama, United States
Providence Medical Center - Burbank, California, United States
Advanced Medical Research - La Palma, California, United States
Millennium Clinical Trials - Westlake Village, California, United States
University of Colorado Denver - Aurora, Colorado, United States
Clinical Res Of W Florida - Clearwater, Florida, United States
GNP Research - Cooper City, Florida, United States
IRIS Research and Development - Plantation, Florida, United States
Clinical Research of West Florida Inc - Tampa, Florida, United States
Parris and Associates Rheumatology - Lawrenceville, Georgia, United States
Robert A Hozman MD SC - Skokie, Illinois, United States
Willow Rheumatology Wellness - Willowbrook, Illinois, United States
Accurate Clinical Research - Lake Charles, Louisiana, United States
University Of Maryland - Baltimore, Maryland, United States
Henry Ford Health - Detroit, Michigan, United States
Ahmed Arif Medical Research Center - Grand Blanc, Michigan, United States
Paramount Med Rsrch and Consult LLC - Middleburg Heights, Ohio, United States
West Tennessee Research Institute - Jackson, Tennessee, United States
Shelby Research LLC - Memphis, Tennessee, United States
Novel Research LLC - Bellaire, Texas, United States
Accurate Clinical Research - League City, Texas, United States
Epic Medical Research - Red Oak, Texas, United States
Novartis Investigative Site - Bangkok, Thailand
Novartis Investigative Site - Bangkok, Thailand
Novartis Investigative Site - Barcelona, Spain
Novartis Investigative Site - Beijing, China
Novartis Investigative Site - Beijing, China
Novartis Investigative Site - Bogotá, Colombia
Novartis Investigative Site - Braga, Portugal
Novartis Investigative Site - Brasov, Romania
Novartis Investigative Site - Brno, Czechia
Novartis Investigative Site - Bucharest, Romania
Novartis Investigative Site - Bydgoszcz, Poland
Novartis Investigative Site - Bydgoszcz, Poland
Novartis Investigative Site - Bytom, Poland
Novartis Investigative Site - Caba, Argentina
Novartis Investigative Site - Caba, Argentina
Novartis Investigative Site - Guatemala City, Guatemala
Novartis Investigative Site - Gwangju, South Korea
Novartis Investigative Site - Gyula, Hungary
Novartis Investigative Site - Haifa, Israel
Novartis Investigative Site - Kaohsiung City, Taiwan
Novartis Investigative Site - Košice, Slovakia
Novartis Investigative Site - Lisbon, Portugal
Novartis Investigative Site - Madrid, Spain
Novartis Investigative Site - Montpellier, France
Novartis Investigative Site - México, Mexico
Novartis Investigative Site - New Delhi, India
Novartis Investigative Site - New Delhi, India
Novartis Investigative Site - Paris, France
Novartis Investigative Site - Paris, France
Novartis Investigative Site - Plovdiv, Bulgaria
Novartis Investigative Site - Prague, Czechia
Novartis Investigative Site - Ramat Gan, Israel
Novartis Investigative Site - Salvador, Brazil
Novartis Investigative Site - San Miguel de Tucumán, Argentina
Novartis Investigative Site - Seoul, South Korea
Novartis Investigative Site - Seoul, South Korea
Novartis Investigative Site - Shanghai, China
Novartis Investigative Site - Sofia, Bulgaria

Showing 60 of 143 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →