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NCT06133972 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
A Phase 3 study of Systemic Lupus Erythematosus, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 550
- Enrollment target
- 20
- Study locations
NCT06133972 is a Phase 3 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 550 participants, above the 375-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT06133972, a Phase 3 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ianalumab
Study Locations (20)
California
- Providence Medical Center - Burbank
- Advanced Medical Research - La Palma
- Millennium Clinical Trials - Westlake Village
Florida
- Clinical Res Of W Florida - Clearwater
- GNP Research - Cooper City
- IRIS Research and Development - Plantation
Illinois
- Robert A Hozman MD SC - Skokie
- Willow Rheumatology Wellness - Willowbrook
Michigan
- Henry Ford Health - Detroit
- Ahmed Arif Medical Research Center - Grand Blanc
Tennessee
- West Tennessee Research Institute - Jackson
- Shelby Research LLC - Memphis
Texas
- Novel Research LLC - Bellaire
- Accurate Clinical Research - League City
Alabama
- Pinnacle Research Group Llc - Anniston
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2024-05-21 |
| Est. Completion | 2032-04-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06133972
The ClinicalTrials.gov registry entry for NCT06133972 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 375-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (47% 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.
NCT06133972 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06133972 about?
NCT06133972 is a clinical study titled "Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).". The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
What is the current status of trial NCT06133972?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2024-05-21. Estimated completion is 2032-04-05.
What conditions does trial NCT06133972 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT06133972?
The interventions under investigation include: Placebo (DRUG), Ianalumab (DRUG).
Who is sponsoring clinical trial NCT06133972?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06133972 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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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