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
Public ClinicalTrials.gov record NCT06293365. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL Pre-filled Syringe With 1 mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06293365
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 155 participants
Conditions and interventions
Interventions
- VAY736 1ml PFS Biological
- VAY736 2 ml PFS Biological
- VAY736 2ml AI Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2, 2024 (Actual)
- Primary completion
- Feb 17, 2026 (Actual)
- Completion
- Jan 16, 2029 (Estimated)
- Last update posted
- Oct 14, 2026
2024 – 2029
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group Llc | Anniston | Alabama | 36207 | — |
| Providence Medical Foundation | Fullerton | California | 92835 | — |
| Advanced Medical Research | La Palma | California | 90623 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Parris and Associates Rheumatology | Lawrenceville | Georgia | 30044 | — |
| Indiana Univ School of Dentistry | Indianapolis | Indiana | 46202 | — |
| Ochsner Health System | Baton Rouge | Louisiana | 70809 | — |
| Ahmed Arif Medical Research Center | Grand Blanc | Michigan | 48439 | — |
| Paramount Med Rsrch and Consult LLC | Middleburg Heights | Ohio | 44130 | — |
| RAO Research LLC | Oklahoma City | Oklahoma | 73116 | — |
| Altoona Center for Clin Res | Duncansville | Pennsylvania | 16635 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Shelby Research LLC | Memphis | Tennessee | 38119 | — |
| Novel Research LLC | Bellaire | Texas | 77401 | — |
| Southwest Rheum Rsrch LLC | Mesquite | Texas | 75150 | — |
| Uni of Texas Health Science Center | San Antonio | Texas | 78229 | — |
| Advanced Rheumatology of Houston | The Woodlands | Texas | 77382 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06293365, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06293365 live on ClinicalTrials.gov.