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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Amgen
Study ID
NCT04540497
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • IgG4 Related Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inebilizumab — DRUG
    Inebilizumab is a monoclonal antibody that depletes B cells.
  • Placebo — OTHER
    Placebo

Study Details

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

Key Dates

Start date
Dec 4, 2020
Status verified
Nov 2025
Primary completion
Apr 9, 2024
Completion
Oct 31, 2028

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VIB0551
    Inebilizumab administered as an IV infusion.
  • Placebo Comparator: Placebo
    Placebo administered as an IV infusion.

Primary Outcome Measure

RCP: Time to Disease Flare [ Time Frame: Up to Week 52 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Viela Bio Investigative SitePalo AltoCalifornia94305-
Viela Bio Investigative SiteAtlantaGeorgia30322-
Viela Bio Investigative SiteBaltimoreMaryland21287-
Viela Bio Investigative SiteBostonMassachusetts02114-

Find similar trials in Palo Alto, CA

By research site
Viela Bio Investigative Site· Palo Alto, CAViela Bio Investigative Site· Atlanta, GAViela Bio Investigative Site· Baltimore, MDViela Bio Investigative Site· Boston, MA

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