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NCT04540497Phase 3ACTIVE NOT RECRUITING

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

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
IgG4 Related Disease
Interventions / Drugs
InebilizumabPlacebo
View on ClinicalTrials.gov ↗
Sponsor
AMGN
Amgen Inc
Biologics
F35/100
Study Details
Enrollment135 participants
Primary Completion—
Lead SponsorAmgen
Data Retrieved2026-04-13 18:29:34.158126+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 135 participants
Sponsor Catalyst Profile

Amgen Inc (AMGN) is the sponsoring company for this trial. BiotechSign currently grades this company F (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AMGN Full Pipeline →All Companies →
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