Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
Public ClinicalTrials.gov record NCT05624749. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05624749
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 288 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 20, 2023
- Primary completion
- Apr 11, 2027
- Completion
- Apr 8, 2029
- Last update posted
- Aug 20, 2026
2023 – 2029
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group LLC | Anniston | Alabama | 36207-5710 | — |
| Advanced Medical Research | La Palma | California | 90623 | — |
| University of California LA | Los Angeles | California | 90095 | — |
| Homestead Assoc In Research Inc | Homestead | Florida | 33033 | — |
| IRIS Research and Development | Plantation | Florida | 33324 | — |
| Emory University | Atlanta | Georgia | 30307 | — |
| Willow Rheumatology Wellness | Willowbrook | Illinois | 60527 | — |
| Bluegrass Community Research Inc | Lexington | Kentucky | 40504 | — |
| Accurate Clinical Research | Lake Charles | Louisiana | 70601 | — |
| UMC New Orleans | New Orleans | Louisiana | 70112 | — |
| University Of Maryland | Baltimore | Maryland | 21201 | — |
| Ahmed Arif Medical Research Center | Grand Blanc | Michigan | 48439 | — |
| Washington Univ School Of Medicine | St Louis | Missouri | 63110 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Novel Research LLC | Bellaire | Texas | 77401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05624749, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05624749 live on ClinicalTrials.gov.