# 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)

> **NCT05639114** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 436 (actual)

## Conditions studied

- Systemic Lupus Erythematosus

## Interventions

- **DRUG:** Ianalumab
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05639114
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-03-02
- **Primary completion:** 2027-03-24
- **Final completion:** 2029-03-21
- **Target enrollment:** 436 (ACTUAL)
- **Last updated:** 2026-03-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05639114

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05639114, "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)". Retrieved via AI Analytics 2026-09-16 from https://api.ai-analytics.org/clinical/NCT05639114. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*