IgG4-Related Disease
Conditions
Interventions
RCP: Blinded treatment on Day 1, Day 15, and Week 26:
- Inebilizumab group: Inebilizumab 300 mg intravenous (IV)
- Placebo group: IV placebo
Both groups: Oral prednisone (or equivalent) tablets from D
blinded inebilizumab 300 mg or matching placebo on Day 15 (depending on assigned RCP treatment), and then a single inebilizumab 300 mg IV infusion every 6 months for the duration of the OLP.
Sponsors
Ebana Rika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults, greater than or equal to 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.
Exclusion criteria
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 the 6 months prior to screening. 4. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening. 5. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection. 6. Receipt of live vaccine or live therapeutic infectious agent within 2 weeks prior to screening. 7. Estimated glomerular filtration rate < 30 mL/min/1.73 m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare. | — |
Countries
Argentina, Australia, Canada, China, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden, Turkey, UK, USA
Contacts
Public ContactRika Ebana
Medpace Japan KK
Outcome results
None listed