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A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

NCT05662241 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-02-04

No results posted yet for this study

Summary

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

Conditions

  • IgG4 Related Disease

Interventions

DRUG

Obexelimab

Obexelimab is a monoclonal antibody that co-engages CD19 and FcγRIIb to inhibit B cell activity

OTHER

Placebo

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2025-11-13
Completion
2029-02-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • 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 NCT05662241 on ClinicalTrials.gov