A Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
- Conditions
- Other specified disorders involving the immune mechanism, not elsewhere classified,
- Registration Number
- CTRI/2021/04/032702
- Lead Sponsor
- Viela Bio acquired by Horizon Therapeutics
- Brief Summary
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 is to 1 ratio to receive intravenous 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 3 year open label treatment period. The study also includes a Safety Follow up Period SFUP after IP discontinuation of up to 730 day
The expected duration of each subjects participation in this study is up to 400 days screening and RCP plus up to 1095 days for eligible subjects who enroll in the optional open label period OLP and up to 730 days for the SFUP after IP discontinuation for a total maximum duration of up to 2273 days screening RCP interval between RCP and OLP OLP and FSUP
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 200
- Male or female adults, ≥ 18 years of age at time of informed consent.
- Clinical diagnosis of IgG4-RD.
- 3 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 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.
- 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 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. RCP-52 week RCP
- Secondary Outcome Measures
Name Time Method Incidence of TEAEs, TESAEs, & treatment-emergent adverse events of special interest (AESIs) during the 52-week RCP & during the OLP. 325 weeks
Trial Locations
- Locations (1)
ChanRe Rheumatology and Immunology Center and Research
🇮🇳Bangalore, KARNATAKA, India
ChanRe Rheumatology and Immunology Center and Research🇮🇳Bangalore, KARNATAKA, IndiaDr Chandrashekara SrikantiahPrincipal investigator9845071151chandrashekara_s@yahoo.com