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)
Public ClinicalTrials.gov record NCT05639114. 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, Parallel Group, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05639114
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 436 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
- Mar 2, 2023 (Actual)
- Primary completion
- Mar 26, 2027 (Estimated)
- Completion
- Mar 23, 2029 (Estimated)
- Last update posted
- Oct 14, 2026
2023 – 2029
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group Llc | Anniston | Alabama | 36207 | — |
| Providence Medical Center | Burbank | California | 91505 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| Millennium Clinical Trials | Westlake Village | California | 91361 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | — |
| Clinical Res Of W Florida | Clearwater | Florida | 33765 | — |
| GNP Research | Cooper City | Florida | 33024 | — |
| Clinical Research of West Florida Inc | Tampa | Florida | 33603 | — |
| Parris and Associates Rheumatology | Lawrenceville | Georgia | 30044 | — |
| Chicago Clinical Research Inst | Chicago | Illinois | 60607 | — |
| Robert A Hozman MD SC | Skokie | Illinois | 60076 | — |
| Lake Cumberland Rheumatology and In | New Albany | Indiana | 47150 | — |
| Henry Ford Health | Detroit | Michigan | 48202 | — |
| Sahni Rheumatology and Therapy | West Long Branch | New Jersey | 07764 | — |
| Paramount Med Rsrch and Consult LLC | Middleburg Heights | Ohio | 44130 | — |
| University Of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Shelby Research LLC | Memphis | Tennessee | 38119 | — |
| Accurate Clinical Research Research | Baytown | Texas | 77521 | — |
| Novel Research LLC | Bellaire | Texas | 77401 | — |
| Accurate Clinical Research | League City | Texas | 77573 | — |
| Epic Medical Research | Red Oak | Texas | 75154 | — |
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 113 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05639114, 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 Oct 14, 2026 · Synced Oct 16, 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 public registry record, listed eligibility criteria, and available contact information for NCT05639114 live on ClinicalTrials.gov.