Active — Not RecruitingPhase 3

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

United States, Argentina135 participantsStarted 2020-12-04

Plain-language summary

This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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 the 6 months prior to screening.
✕. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening.
✕. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection.
✕. Receipt of live vaccine or live therapeutic infectious agent within 2 weeks prior to screening.
✕. Estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2.

RCP: Time to Disease Flare

Timeframe: Up to Week 52

NCT IDNCT04540497

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-09

Results submitted2025-04-15

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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 the 6 months prior to screening.
✕. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening.
✕. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection.
✕. Receipt of live vaccine or live therapeutic infectious agent within 2 weeks prior to screening.
✕. Estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2.