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Not yet recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT07222553

Public ClinicalTrials.gov record NCT07222553. 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.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 8:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07222553
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Amgen
Industry
Enrollment
15 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 18 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
Oct 30, 2026
Primary completion
Jun 9, 2031
Completion
Jun 9, 2031
Last update posted
Aug 26, 2026

2026 – 2031

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
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

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 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07222553, 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 Aug 26, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07222553 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →