Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- Amgen
- Study ID
- NCT07222553
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Immunoglobulin G4-related Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Inebilizumab — DRUGInebilizumab will be administered via IV infusion.
Study Details
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD.
Key Dates
- First listed
- Oct 30, 2025
- Start date
- Oct 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Jun 10, 2031
- Completion
- Jun 10, 2031
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: InebilizumabParticipants will receive Inebilizumab via intravenous (IV) infusion.
Primary Outcome Measure
Maximum Plasma Concentration (Cmax) of Inebilizumab [ Time Frame: Up to Day 561 ]
Central Contacts
- Amgen Call Center866-572-6436
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of South Florida - Carol and Frank Morsani Center for Advanced Health Care | Tampa | Florida | 33612 | - |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | - |
| University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | - |