Inebilizumab for Immunoglobulin-Related Disease

Not yet recruiting at 13 trial locations
AC
Overseen ByAmgen Call Center
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Amgen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for children and teens aged 2 to under 18 years who have IgG4-related disease affecting certain organs, weigh at least 17 kg, have received all required vaccines, and need treatment beyond or in addition to steroids. Consent from a parent/guardian is needed if the child is too young.

Inclusion Criteria

I have given my consent, or my legal guardian has if I'm underage, to participate.
This is a key eligibility criterion for the study.
I weigh at least 17 kg.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • Inebilizumab

Trial Overview

The study tests how the drug inebilizumab works and how safe it is in kids with IgG4-related disease. All participants receive inebilizumab, and researchers monitor its effects on the body over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: InebilizumabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London