Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2020-12-04 |
| Est. Completion | 2028-10-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04540497
The ClinicalTrials.gov registry entry for NCT04540497 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 59-participant average among 4 other IgG4 Related Disease trials with a reported enrollment target (129% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for IgG4 Related Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
ACTIVE NOT RECRUITING · Phase 3
-
Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
RECRUITING · Phase 1
-
A Study of Efgartigimod in Patients With IgG4-Related Disease
RECRUITING · Phase 2
-
Treatment of IgG4-Related Disease With Revlimid and Rituximab
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.