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A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

NCT04540497 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-12-11

Study results available
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Summary

This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

Conditions

  • IgG4 Related Disease

Interventions

DRUG

Inebilizumab

Inebilizumab is a monoclonal antibody that depletes B cells.

OTHER

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2024-04-09
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04540497 on ClinicalTrials.gov