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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05639114
The ClinicalTrials.gov registry entry for NCT05639114 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 436 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 376-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (16% higher). 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.
NCT05639114 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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