Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified
Conditions
Interventions
Intervention1: Inebilizumab: Inebilizumab administered as an IV infusion. Inebilizumab is a monoclonal antibody that depletes B cells.
Control Intervention1: Placebo: Placebo administered as an IV inf
Sponsors
Viela Bio acquired by Horizon Therapeutics
Eligibility
Inclusion criteria
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
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 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
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-determined IgG4 RD flare within the 52-week RCP.Timepoint: RCP-52 week RCP | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of TEAEs, TESAEs, & treatment-emergent adverse events of special interest (AESIs) during the 52-week RCP & during the OLP.Timepoint: 325 weeks | — |
Countries
Argentina, Australia, Canada, China, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden, Turkey, United Kingdom, United States of America
Contacts
Public ContactShweta Moolya
Medpace Clinical Research India Pvt. Ltd
Outcome results
None listed