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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viela Bio

Criteria

Key Inclusion Criteria:

1. Male or female adults, ≥ 18 years of age at time of informed consent.

2. Clinical diagnosis of IgG4-RD.

3. Fulfillment of the 2019 ACR/EULAR classification criteria.

4. Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.

5. IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD

6. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception

Key Exclusion Criteria:

1. History of solid organ or cell-based transplantation or known immunodeficiency disorder .

2. Active malignancy or history of malignancy that was active within the last 10 years (some specific situations for cervical, skin or prostate cancer are acceptable).

3. Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in prior 6 months

4. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4 weeks

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

6. Live vaccine or therapeutic agent in prior 2 weeks

7. Glomerular filtration rate < 30 mL/min/1.73 m2