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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05624749
The ClinicalTrials.gov registry entry for NCT05624749 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (24% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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