Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

12 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo s.c. monthly
• Ianalumab — DRUG
  Ianalumab s.c. monthly Ianalumab s.c. quarterly

Study Details

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Key Dates

Start date

May 21, 2024

Status verified

Mar 2026

Primary completion

Apr 8, 2030

Completion

Apr 5, 2032

Study Design

Enrollment

550 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ianalumab monthly
  Ianalumab s.c. monthly
• Experimental: Ianalumab quarterly
  Ianalumab s.c. quarterly
• Placebo Comparator: Placebo monthly
  Placebo s.c. monthly

Primary Outcome Measure

Number of treatment-emergent Adverse events/Serious Adverse events [ Time Frame: through study completion, up to approximately 91 months ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111
  [email protected]

Locations (21)

Find similar trials in Anniston, AL

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