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NCT04540497 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of IgG4 Related Disease, sponsored by Amgen.

Active
Registry status
Phase 3
Development phase
135
Enrollment target
20
Study locations

NCT04540497: Active Phase 3 study of IgG4 Related Disease, sponsored by Amgen.

NCT04540497 is a Phase 3 study of IgG4 Related Disease that is active but no longer recruiting, run by Amgen. The registered enrollment target is 135 participants, above the 59-participant average among 4 other IgG4 Related Disease trials with a reported enrollment target (129% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04540497, a Phase 3 study of IgG4 Related Disease, is active but no longer recruiting, sponsored by Amgen.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
135 participants
Enrollment target
20
Study locations

Study Summary

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

Primary Outcome

Time to disease flare was defined as the number of days from Day 1 (dosing) to the date of the first treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The date of disease flare was determined by the initiation of any flare treatment, including new or increased glucocorticoid (GC) treatment, other immunotherapy, or an interventional procedure, as deemed necessary by the Investigator to address the flare. Kaplan-Meier (KM) method was used to estimate the med

Conditions Studied

IgG4 Related Disease

Interventions

  • OTHER Placebo
  • DRUG Inebilizumab

Study Locations (20)

Other

  • Viela Bio Investigative Site - Buenos Aires
  • Viela Bio Investigative Site - Mendoza
  • Viela Bio Investigative Site - Fitzroy
  • Viela Bio Investigative Site - Sherbrooke
  • Viela Bio Investigative Site 1 - Toronto
  • Viela Bio Investigative Site 2 - Toronto
  • Viela Bio Investigative Site 1 - Beijing
  • Viela Bio Investigative Site 2 - Beijing
  • Viela Bio Investigative Site 3 - Beijing
  • Viela Bio Investigative Site 4 - Beijing
  • Viela Bio Investigative Site 5 - Beijing
  • Viela Bio Investigative Site - Guandong
  • Viela Bio Investigative Site - Shang’ai

California

  • Viela Bio Investigative Site - Palo Alto

Georgia

  • Viela Bio Investigative Site - Atlanta

Maryland

  • Viela Bio Investigative Site - Baltimore

Massachusetts

  • Viela Bio Investigative Site - Boston

Queensland

  • Viela Bio Investigative Site - Auchenflower

South Australia

  • Viela Bio Investigative Site - Adelaide

Inner Mongolia

  • Viela Bio Investigative Site - Hohhot

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2020-12-04
Est. Completion 2028-10-31
Phase Phase 3
Amgen

558 total trials

What the registry record for NCT04540497 still lists

NCT04540497 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 59-participant average among 4 other IgG4 Related Disease trials with a reported enrollment target (129% higher).

The record links to 1 condition, with IgG4 Related Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04540497 names 20 study sites across 8 states, led by Other, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT04540497 about?

NCT04540497 is a clinical study titled "A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease". This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

What is the current status of trial NCT04540497?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2020-12-04. Estimated completion is 2028-10-31.

What conditions does trial NCT04540497 study?

This clinical trial studies the following conditions: IgG4 Related Disease.

What interventions are being tested in trial NCT04540497?

The interventions under investigation include: Placebo (OTHER), Inebilizumab (DRUG).

Who is sponsoring clinical trial NCT04540497?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04540497 being conducted?

This trial has 20 study locations across California, Georgia, Maryland, Massachusetts, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT04540497, the US trial registry maintained by the National Library of Medicine. NCT04540497 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.