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ACTIVE NOT RECRUITING Phase 2

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

NCT06293365 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

Interventions

  • BIOLOGICAL VAY736 1ml PFS
  • BIOLOGICAL VAY736 2 ml PFS
  • BIOLOGICAL VAY736 2ml AI

Study Locations (20)

Texas

  • Novel Research LLC — Bellaire
  • Southwest Rheum Rsrch LLC — Mesquite
  • Uni of Texas Health Science Center — San Antonio
  • Advanced Rheumatology of Houston — Spring

California

  • Providence Medical Foundation — Fullerton
  • Advanced Medical Research — La Palma

Tennessee

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

Alabama

  • Pinnacle Research Group Llc — Anniston

Florida

  • Conquest Research — Winter Park

Georgia

  • Parris and Associates Rheumatology — Lawrenceville

Indiana

  • Indiana Univ School of Dentistry — Indianapolis

Louisiana

  • Ochsner Health System — Baton Rouge

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2024-07-02
Est. Completion 2029-01-04
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06293365

The ClinicalTrials.gov registry entry for NCT06293365 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 155 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 3 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 3 interventions — of which VAY736 1ml PFS 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: NCT06293365 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, California, Tennessee. 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 NCT06293365 about?

NCT06293365 is a clinical study titled "Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease". The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianal...

What is the current status of trial NCT06293365?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2024-07-02. Estimated completion is 2029-01-04.

What conditions does trial NCT06293365 study?

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

What interventions are being tested in trial NCT06293365?

The interventions under investigation include: VAY736 1ml PFS (BIOLOGICAL), VAY736 2 ml PFS (BIOLOGICAL), VAY736 2ml AI (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06293365?

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 NCT06293365 being conducted?

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