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NCT05639114 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Systemic Lupus Erythematosus, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 436
- Enrollment target
- 20
- Study locations
NCT05639114: Active Phase 3 study of Systemic Lupus Erythematosus, sponsored by Novartis Pharmaceuticals.
NCT05639114 is a Phase 3 study of Systemic Lupus Erythematosus that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 436 participants, above the 376-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05639114, a Phase 3 study of Systemic Lupus Erythematosus, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 436 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ianalumab
Study Locations (20)
California
- Providence Medical Center - Burbank
- University of California San Diego - La Jolla
- Millennium Clinical Trials - Westlake Village
Florida
- Clinical Res Of W Florida - Clearwater
- GNP Research - Cooper City
- Clinical Research of West Florida Inc - Tampa
Illinois
- Chicago Clinical Research Inst - Chicago
- Robert A Hozman MD SC - Skokie
Texas
- Accurate Clinical Research Research - Baytown
- Novel Research LLC - Bellaire
Alabama
- Pinnacle Research Group Llc - Anniston
Colorado
- University of Colorado - Aurora
Connecticut
- Yale University School Of Medicine - New Haven
Georgia
- Parris and Associates Rheumatology - Lawrenceville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 436 participants |
| Start Date | 2023-03-02 |
| Est. Completion | 2029-03-21 |
| Phase | Phase 3 |
What the registry record for NCT05639114 still lists
NCT05639114 is an interventional study that assigns participants to a tested intervention. The registered 436 participants enrollment target is mid-sized for trials with a published cap, above the 376-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05639114 names 20 study sites across 14 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05639114 about?
NCT05639114 is a clinical study titled "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)". 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).
What is the current status of trial NCT05639114?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 436 participants. The study started on 2023-03-02. Estimated completion is 2029-03-21.
What conditions does trial NCT05639114 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT05639114?
The interventions under investigation include: Placebo (DRUG), Ianalumab (DRUG).
Who is sponsoring clinical trial NCT05639114?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05639114 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05639114's enrollment target sits among peer trials
436 20th of 99 higher than 80 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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