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

Phase 3
Active, not recruiting
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
Inclusion Criteria
  • 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.
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 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
NameTimeMethod
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
NameTimeMethod
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, India
Dr Chandrashekara Srikantiah
Principal investigator
9845071151
chandrashekara_s@yahoo.com

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