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NCT05624749 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
A Phase 3 study of Systemic Lupus Erythematosus, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 288
- Enrollment target
- 20
- Study locations
NCT05624749: Active Phase 3 study of Systemic Lupus Erythematosus, sponsored by Novartis Pharmaceuticals.
NCT05624749 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 288 participants, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05624749, 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
- 288 participants
- Enrollment target
- 20
- Study locations
Study Summary
The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly 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)
Buenos Aires
- Novartis Investigative Site - La Plata
- Novartis Investigative Site - Quilmes
- Novartis Investigative Site - San Miguel
California
- Advanced Medical Research - La Palma
- University of California LA - Los Angeles
Florida
- Homestead Assoc In Research Inc - Homestead
- IRIS Research and Development - Plantation
Louisiana
- Accurate Clinical Research - Lake Charles
- UMC New Orleans - New Orleans
Alabama
- Pinnacle Research Group LLC - Anniston
Georgia
- Emory University - Atlanta
Illinois
- Willow Rheumatology Wellness - Willowbrook
Kentucky
- Bluegrass Community Research Inc - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2023-04-21 |
| Est. Completion | 2029-04-09 |
| Phase | Phase 3 |
What the registry record for NCT05624749 still lists
NCT05624749 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (24% lower).
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.
NCT05624749 names 20 study sites across 15 states, led by Buenos Aires, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05624749 about?
NCT05624749 is a clinical study titled "Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)". The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly 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 NCT05624749?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2023-04-21. Estimated completion is 2029-04-09.
What conditions does trial NCT05624749 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT05624749?
The interventions under investigation include: placebo (DRUG), ianalumab (DRUG).
Who is sponsoring clinical trial NCT05624749?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05624749 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. 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 NCT05624749's enrollment target sits among peer trials
288 32nd of 99 higher than 68 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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