Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) (NCT05639114)
A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
🩺 Plain-English Summary (8th-Grade Level)
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).
Who can join: Review the eligibility criteria below.
Location: Pinnacle Research Group Llc — Anniston, Alabama
Age range: 12 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (135 Sites)
Showing the first 25 of 135 sites.
- Pinnacle Research Group Llc — Anniston, Alabama
- Providence Medical Center — Burbank, California
- University of California San Diego — La Jolla, California
- Millennium Clinical Trials — Westlake Village, California
- University of Colorado — Aurora, Colorado
- Yale University School Of Medicine — New Haven, Connecticut
- Clinical Res Of W Florida — Clearwater, Florida
- GNP Research — Cooper City, Florida
- Clinical Research of West Florida Inc — Tampa, Florida
- Parris and Associates Rheumatology — Lawrenceville, Georgia
- Chicago Clinical Research Inst — Chicago, Illinois
- Robert A Hozman MD SC — Skokie, Illinois
- Lake Cumberland Rheumatology and In — New Albany, Indiana
- Henry Ford Health — Detroit, Michigan
- Sahni Rheumatology and Therapy — West Long Branch, New Jersey
- Paramount Med Rsrch and Consult LLC — Middleburg Heights, Ohio
- University Of Pittsburgh — Pittsburgh, Pennsylvania
- Shelby Research LLC — Memphis, Tennessee
- Accurate Clinical Research Research — Baytown, Texas
- Novel Research LLC — Bellaire, Texas
- Accurate Clinical Research — League City, Texas
- Epic Medical Research — Red Oak, Texas
- Novartis Investigative Site — San Miguel, Tucumán Province
- Novartis Investigative Site — San Miguel de Tucumán,
- Novartis Investigative Site — Fortaleza, Ceará
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Systemic Lupus Erythematosus
- A Study of Obexelimab in Patients With Systemic Lupus Erythematosus — Peoria, Arizona
- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus — Anniston, Alabama
- REACH (Restore Energy, Activity Can Help) Lupus Study — Boston, Massachusetts
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus — Birmingham, Alabama
- A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice — Innsbruck, Tyrol
- A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) — Birmingham, Alabama
Explore by condition: All Systemic Lupus Erythematosus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.