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NCT06293365 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
- 20
- Study locations
NCT06293365: Active Phase 2 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by Novartis Pharmaceuticals.
NCT06293365 is a Phase 2 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 155 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06293365, a Phase 2 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2024-07-02 |
| Est. Completion | 2029-01-04 |
| Phase | Phase 2 |
What the registry record for NCT06293365 still lists
NCT06293365 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower).
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.
NCT06293365 names 20 study sites across 15 states, led by Texas, California, Tennessee.
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.
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).
Who is sponsoring clinical trial NCT06293365?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
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