A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

  • STATUS
    Recruiting
  • End date
    Jun 19, 2024
  • participants needed
    160
  • sponsor
    Viela Bio
Updated on 19 August 2021
Investigator
Jack Ratchford, MD
Primary Contact
Viela Bio Investigative Site (6.6 mi away) Contact
+85 other location

Summary

This study aims to define the efficacy and safety of inebilizumab for the prevention of flare of IgG4-related disease (IgG4-RD).

Description

After a screening period of up to 28 days, subjects with IgG4-RD at high risk of flare due to multi-organ disease and recent active disease will be randomized in a 1:1 ratio to receive intravenous (IV) inebilizumab or placebo after premedication during the 52-week randomized control period (RCP). All subjects will receive an initial tapering dose of glucocorticoids (GCs) to complete treatment of their active disease. Flares occurring during study will be treated. The primary endpoint is time to a first adjudication committee-determined, investigator-treated disease flare during the RCP.. The primary analysis will be conducted when the last subject completes the RCP visit or discontinues the RCP. This study includes an optional 52-week open-label treatment period. The expected duration of each subject's participation in this study is up to 400 days (screening and RCP) or, for eligible subjects who enroll in the optional OLP, up to 813 days (screening, RCP, interval between RCP and OLP, and OLP).

Details
Condition igg4 related disease
Treatment Placebo, Inebilizumab
Clinical Study IdentifierNCT04540497
SponsorViela Bio
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female adults, 18 years of age at time of informed consent
Clinical diagnosis of IgG4-RD
Fulfillment of the 2019 ACR/EULAR classification criteria
Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent
IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD
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

History of solid organ or cell-based transplantation or known immunodeficiency disorder
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)
Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in prior 6 months
Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4 weeks
Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
Live vaccine or therapeutic agent in prior 2 weeks
Glomerular filtration rate < 30 mL/min/1.73 m2
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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