Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD

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 — DRUG
    Inebilizumab 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

Start date
Jul 31, 2026
Status verified
May 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: Inebilizumab
    Participants will receive Inebilizumab via intravenous (IV) infusion.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Inebilizumab [ Time Frame: Up to Day 561 ]

Central Contacts