Overview

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

Status:
Recruiting

Trial end date:
2026-12-31

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Zenas BioPharma (USA), LLC

Criteria

Inclusion Criteria:

1. Males and females, ≥ 18 years of age

2. Clinical diagnosis of IgG4-RD

3. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD

4. Patients must have active IgG4-RD signs/symptoms (i.e., flare) that require the
initiation of GC therapy or the increase in background long-term GC therapy

5. Other inclusion criteria apply

Exclusion Criteria:

1. Has disease in only 1 organ system whose primary manifestation is fibrosis

2. Has received prednisone equivalent given orally at a dose greater than 60 mg/day
within the 4 weeks prior to screening or during screening

3. Has received a non-biologic, disease-modifying anti-rheumatological drug or
immunosuppressive agent other than GCs within the 4 weeks prior to screening

4. Has received an investigational treatment or direct medical intervention on another
clinical study within 12 weeks or < 5 half-lives of the investigational treatment,
whichever is shorter, prior to screening

5. Has received live vaccine or live therapeutic infectious agent within the 2 weeks
prior to screening

6. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of
curative treatment; evidence of hepatitis B infection

7. Use of B cell depleting or targeting agents within 6 months of randomization

8. Other exclusion criteria apply