Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Novartis Pharmaceuticals · NCT06133972
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12–100 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 550
- US sites recruiting
- 21
- Study start
- May 21, 2024
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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).
Being studied: Placebo; Ianalumab
Conditions: Systemic Lupus Erythematosus
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key 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.
Other protocol-defined inclusion/exclusion criteria may apply.
Recruiting US locations
Pinnacle Research Group Llc
Anniston, AL 36207
Site contact: Ruby Fields · +1 256 236 0055 · rfields@pinnacletrials.com
Providence Medical Center
Burbank, CA 91505
Site contact: Sandra Figueroa · +1 818 869 7067 · Sandra.Figueroa@providence.org
Advanced Medical Research
La Palma, CA 90623
Site contact: Reza Azadegan · +1 714 752 6587 · razadegan@advmedresearch.com
University of Colorado Denver
Aurora, CO 80045
Site contact: Chong Pedrick · chong.pedrick@cuanschutz.edu
Clinical Res Of W Florida
Clearwater, FL 33765
Site contact: Jessica Mayfield · +1 727 466 0078 · JMayfield@crwf.com
GNP Research
Cooper City, FL 33024
Site contact: Melissa Pierce · +1 754 248 3589 · melissa@gnpresearch.com
Homestead Assoc In Research Inc
Homestead, FL 33033
Site contact: Mario Hernandez · 13052460873 · mhernandez@associatesinresearch.com
IRIS Research and Development
Plantation, FL 33324
Site contact: Jhon Galindo · +1 954 476 2338 · jgalindo@irisrheumatology.com
Clinical Research of West Florida Inc
Tampa, FL 33603
Site contact: Abby Carlson · +1 813 870 1292 · ACarlson@crwf.com
Parris and Associates Rheumatology
Lawrenceville, GA 30044
Site contact: Mannai Coutermarsh · +17709621616#8334 · m.coutermarsh@parrisandassociates.net
Willow Rheumatology Wellness
Willowbrook, IL 60527
Site contact: Lubna Ali · lali@willowrheum.com
Accurate Clinical Research
Lake Charles, LA 70601
Site contact: Machell Broussard · mbroussard@accurateclinicalresearch.com
Henry Ford Health
Detroit, MI 48202
Site contact: Jenna Hudy · +1 313 916 1984 · jhudy1@hfhs.org
Ahmed Arif Medical Research Center
Grand Blanc, MI 48439
Site contact: Iman Abdelrahman · +1 810 953 8700 · iman@aamrc.net
Paramount Med Rsrch and Consult LLC
Middleburg Heights, OH 44130
Site contact: Denine Ryan · +1 440 891 9395 · deniner64@gmail.com
University Of Pittsburgh
Pittsburgh, PA 15213
Site contact: Kathryn Lemon · kal128@pitt.edu
West Tennessee Research Institute
Jackson, TN 38305
Site contact: Rachel Williams · 17316330119 · rwilliams@arthritisclinic.org
Shelby Research LLC
Memphis, TN 38119
Site contact: Suvarna Konangula · +1 901 681 9670 · shelbyres1999@outlook.com
Novel Research LLC
Bellaire, TX 77401
Site contact: Hassan Khan · khan@novelresearch.net
Accurate Clinical Research
League City, TX 77573
Site contact: Mariela Martinez · +1 281 422 7179 · mmartinez@accurateclinicalresearch.com
Epic Medical Research
Red Oak, TX 75154
Site contact: Harshini Potluri · +1 469 206 2642 · hpotluri@epicmedresearch.com
Study contacts (from the official record)
- Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
- Novartis Pharmaceuticals · +41613241111 · novartis.email@novartis.com