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

NCT07222553 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 202402022025-520988-41-00
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Immunoglobulin G4-related Disease

Keywords

Immunoglobulin G4-related Disease; Inebilizumab; AMG 335; IgG4-related disease; IgG4-RD

Outcome Measures

Primary Outcomes (11)

• Maximum Plasma Concentration (Cmax) of Inebilizumab

  Up to Day 561

• Area Under the Plasma Concentration-time Curve (AUC) of Inebilizumab

  Up to Day 561

• Clearance (CL) of Inebilizumab

  Up to Day 561

• Terminal Half-life (t½) of Inebilizumab

  Up to Day 561

• Volume of Distribution at Steady-state (Vss) of Inebilizumab

  Up to Day 561

• Change from Baseline in CD20+ B-cell Counts

  Baseline and Day 561

• Number of Participants Experiencing Adverse Events (AEs)

  Up to Day 561

• Number of Participants Experiencing Serious Adverse Events (SAEs)

  Baseline up to Day 561

• Number of Participants Experiencing Events of Interest (EOIs)

  Baseline up to Day 561

• Number of Participants Experiencing Clinically Significant Changes from Baseline in Laboratory Parameters

  Baseline up to Day 561

• Number of Participants Experiencing Clinically Significant Changes from Baseline in Vital Signs

  Baseline up to Day 561

Secondary Outcomes (5)

• Time-to-first Treated Flare Across 52 Weeks

  Up to Week 52

• Percentage of Flare-free Participants Across 52 Weeks

  Up to Week 52

• Annualized Flare Rate Across 52 Weeks

  Up to Week 52

• Presence of Antidrug Antibodies (ADA) Before and After Initiation of Treatment

  Day 1 to Day 561

• Percent Reduction from Baseline in Daily Glucocorticoid Dose at Week 52

  Baseline and Week 52

Study Arms (1)

Inebilizumab

EXPERIMENTAL

Participants will receive Inebilizumab via intravenous (IV) infusion.

Drug: Inebilizumab

Interventions

Inebilizumab DRUG

Inebilizumab will be administered via IV infusion.

Inebilizumab

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants must weigh ≥ 17 kg to be eligible for enrollment.
• Participant has provided informed consent/assent before initiation of any study-specific activities/procedures. Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.
• Age 2 to \< 18 years at the time of screening. For participants who reach the age of legal consent during the clinical study, notification will be required, and a new consent form must be signed by the participant for continuation in the study.
• Clinical diagnosis of IgG4-RD.
• Receipt of all age-appropriate and locally-required vaccinations before screening.
• Participants requiring treatment in addition to or other than glucocorticoids (GCs) for IgG4-RD according to PI's assessment at screening.
• Participants who are on GCs for the treatment of IgG4-RD should remain on a stable dose for at least 2 weeks before enrollment (Day 1). Tapering post enrollment will be at PI's discretion.

You may not qualify if:

• Participants with any of the following abnormal liver function tests in the presence of hepatobiliary IgG4-RD activity:
• aspartate aminotransferase (AST) \> 10 × upper limit of normal (ULN)
• alanine aminotransferase (ALT) \> 10 × ULN
• total bilirubin (TBL) \> 5 × ULN Screening liver function tests may be repeated before Day 1 to permit abnormal values due to hepatobiliary IgG4-RD activity to respond to GC treatment.
• Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality, including any of the following at screening (one repeat test may be conducted to confirm results within the same screening period):
• platelet count \< 75000/μL (or \< 75 × 109/L)
• absolute neutrophil count \< 1200 cells/μL
• total Ig \< 600 mg/dL
• CD4 T lymphocyte count \< 300 cells/µL
• hemoglobin \< 8 g/dL (or \< 80 g/L).
• Estimated glomerular filtration rate \< 45 mL/min/1.73 m\^2.
• B-cell counts \< one-half of the lower limit of normal (LLN) for age according to the central laboratory.
• Diagnosed with a concurrent autoimmune disease that is uncontrolled or requires any prohibited medication (unless approved by the medical monitor).
• Clinically significant serious active or chronic viral, bacterial, or fungal infection that requires treatment with anti-infectives, hospitalization, or, in the investigator's opinion, represents an additional risk to the participant, within 2 months before Day 1 of study.
• Known history of congenital or acquired immunodeficiency (eg, due to human immunodeficiency virus \[HIV\] infection, splenectomy, immunosuppression-related or idiopathic T-cell deficiencies) that predisposes the participant to infection.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

inebilizumab

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 30, 2025
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): June 10, 2031
• Study Completion (Estimated): June 10, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.