Trials / Not Yet Recruiting
Not Yet RecruitingNCT07222553
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Immunoglobulin G4-related Disease (IgG4-RD)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inebilizumab | Inebilizumab will be administered via IV infusion. |
Timeline
- Start date
- 2026-04-03
- Primary completion
- 2031-06-10
- Completion
- 2031-06-10
- First posted
- 2025-10-30
- Last updated
- 2025-12-22
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07222553. Inclusion in this directory is not an endorsement.