Trial Search Results
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
This study aims to define the efficacy and safety of inebilizumab for the prevention of flare of IgG4-related disease (IgG4-RD).
Stanford is currently not accepting patients for this trial.
- Drug: Inebilizumab
- Other: Placebo
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
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
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study