Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT06133972 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • DRUG Placebo
  • DRUG Ianalumab

Study Locations (20)

California

  • Providence Medical Center — Burbank
  • Advanced Medical Research — La Palma
  • Millennium Clinical Trials — Westlake Village

Florida

  • Clinical Res Of W Florida — Clearwater
  • GNP Research — Cooper City
  • IRIS Research and Development — Plantation

Illinois

  • Robert A Hozman MD SC — Skokie
  • Willow Rheumatology Wellness — Willowbrook

Michigan

  • Henry Ford Health — Detroit
  • Ahmed Arif Medical Research Center — Grand Blanc

Tennessee

  • West Tennessee Research Institute — Jackson
  • Shelby Research LLC — Memphis

Texas

  • Novel Research LLC — Bellaire
  • Accurate Clinical Research — League City

Alabama

  • Pinnacle Research Group Llc — Anniston

Colorado

  • University of Colorado Denver — Aurora

Trial Details

FieldValue
Enrollment Target 550 participants
Start Date 2024-05-21
Est. Completion 2032-04-05
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 NCT06133972

The ClinicalTrials.gov registry entry for NCT06133972 describes a study currently listed as 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 550 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: NCT06133972 reports 20 study locations spanning 12 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 NCT06133972 about?

NCT06133972 is a clinical study titled "Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).". 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).

What is the current status of trial NCT06133972?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2024-05-21. Estimated completion is 2032-04-05.

What conditions does trial NCT06133972 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 NCT06133972?

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 NCT06133972?

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 NCT06133972 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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