Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

Study acronym: SIRIUS-LN ext
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Re-verified, no change to tracked fields
  2. Study sites: 49 to 51
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 4 words
  3. Study sites: 47 to 49v12
  4. Trial sites expanded: 41 → 47 locationsv11
  5. Primary and study completion dates pushed to Aug 1, 2035v10 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 315 → 348 participants
    • Trial sites expanded: 25 → 41 locations
    • Secondary endpoints: 6 to 3
    • Study description expanded, about 4 words
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 21 to 25v9
  2. Enrollment target: 316 to 315
    • Study sites: 19 to 21
    • Primary completion date: Jul 18, 2030 to Jul 16, 2030
    • Study completion date: Jul 28, 2032 to Jul 16, 2032
    v8
  3. Study sites: 11 to 19v7
  4. Study sites: 8 to 11v6
  5. Study sites: 5 to 8v5
  6. Study sites: 3 to 5v4
  7. Study sites: 2 to 3
    • Primary completion date: Jul 26, 2030 to Jul 18, 2030
    • Start date: May 21, 2025 to May 19, 2025
    v3
  8. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Jul 16, 2030 to Jul 26, 2030
    • Study completion date: Jul 16, 2032 to Jul 28, 2032
    • Start date changed from estimate of May 16, 2025 to May 21, 2025
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novartis
557 trials monitored
See 32 trials at risk
Lupus (SLE)
669 trials monitored
See 29 trials at risk
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.
Trial Details
NCT Number NCT06711887
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Lupus Nephritis
Related terms Lupus Nephritis
Enrollment 348 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov