Immunoglobulin G4-related disease (IgG4-RD) MedDRA version: 20.0 Level: PT Classification code 10077271 Term: Immunoglobulin G4 related disease System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Uplizna
Product Name: Inebilizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INEBILIZUMAB
Current Sponsor code: MEDI-551
Other descriptive name: afuco
Sponsors
Viela Bio, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female adults who have reached the age of consent in the applicable region (eg, =18 years in the US). 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
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, prostate or thyroid 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 |
|---|---|
| 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. .To evaluate the effect of inebilizumab on other measures of disease activity ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): .Incidence of TEAEs, TESAEs, and treatment-emergent adverse events of special interest (AESIs) during the 52-week RCP and during the OLP. .The incidence of ADAs directed against inebilizumab during the RCP. .Annualized flare rate for treated and AC-determined flares during the RCP. .Annualized flare rate for AC-determined flares, whether or not treated, during the RCP. .The proportion of subjects achieving flare-free complete remission at Week 52. Complete remission is defined as an IgG4-RD Responder Index (RI, Wallace et al, 2018) score of 0 at Week 52, no AC-determined flare during the RCP, and no treatment for flare or disease control except the required 8-week GC taper. .Time to initiation of first treatment (medication or procedure) for new or worsening disease activity by the Investigator within the RCP, regardless of AC determination of flare. .Glucocorticoid use, calculated as the cumulative GC dose taken for the purpose of IgG4-RD disease control during the RCP. ;Timepoint(s) of evaluation of this end point: 52-week RCP | — |
Countries
Argentina, Australia, Canada, China, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Viela Bio, Inc.
Outcome results
None listed