Inebilizumab efficacy and safety in IgG4 related disease
- Conditions
- Immunoglobulin G4-related disease (IgG4-RD)MedDRA version: 20.0Level: PTClassification code 10077271Term: Immunoglobulin G4 related diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-000417-33-SE
- Lead Sponsor
- Viela Bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
1.Male or female adults who have reached the age of consent in the applicable region (eg, =18 years in the US, = 20 years in Japan).
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. One organ must meet the requirements for the ACR/EULAR classification criteria; the second organ is as defined by the investigator.
6.Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide (where spermicide is available) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD;Secondary Objective: .To evaluate the safety and tolerability of inebilizumab in patients with IgG4-RD. <br>.To evaluate the effect of inebilizumab on other measures of disease activity<br>;Primary end point(s): Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and 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.;Timepoint(s) of evaluation of this end point: 52-week RCP
- Secondary Outcome Measures
Name Time Method