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Clinical Trial Active — Not Recruiting Phase III NCT05624749

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) — Active Not Recruiting • Phase III • Rheumatology…

📅 03 Jun 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT05624749
Start
2023-04-21
Completion
2027-04-12
ClinicaliQ Trial Snapshot
  • Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) — Active Not Recruiting • Phase III • Rheumatology • NCT05624749.
  • Monthly ianalumab injections added to standard lupus treatment reduced disease activity better than placebo.

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What This Trial Is Studying

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: Systemic Lupus Erythematosus Interventions: ianalumab, placebo Lead Sponsor: Novartis Pharmaceuticals Planned Enrollment: 288 participants

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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Related Clinical Intelligence

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Guideline
Systemic Lupus Erythematosus (BSR Guidelines)
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Guideline
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Rheumatology · 30 Mar 2026
This EULAR guideline addresses 2023 EULAR Recommendations for Systemic Lupus Erythematosus in Rheumatology. Use it to review current recommendation wording, eligibility criteria,…
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