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ACTIVE NOT RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • DRUG Placebo
  • DRUG Ianalumab

Study Locations (20)

California

  • Providence Medical Center — Burbank
  • University of California San Diego — La Jolla
  • Millennium Clinical Trials — Westlake Village

Florida

  • Clinical Res Of W Florida — Clearwater
  • GNP Research — Cooper City
  • Clinical Research of West Florida Inc — Tampa

Illinois

  • Chicago Clinical Research Inst — Chicago
  • Robert A Hozman MD SC — Skokie

Texas

  • Accurate Clinical Research Research — Baytown
  • Novel Research LLC — Bellaire

Alabama

  • Pinnacle Research Group Llc — Anniston

Colorado

  • University of Colorado — Aurora

Connecticut

  • Yale University School Of Medicine — New Haven

Georgia

  • Parris and Associates Rheumatology — Lawrenceville

Trial Details

FieldValue
Enrollment Target 436 participants
Start Date 2023-03-02
Est. Completion 2029-03-21
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05639114

The ClinicalTrials.gov registry entry for NCT05639114 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 436 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05639114 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05639114 about?

NCT05639114 is a clinical study titled "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)". 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).

What is the current status of trial NCT05639114?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 436 participants. The study started on 2023-03-02. Estimated completion is 2029-03-21.

What conditions does trial NCT05639114 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05639114?

The interventions under investigation include: Placebo (DRUG), Ianalumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05639114?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05639114 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial