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A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease.
EU CTIS ID: 2023-508290-81-00
What this study is testing
To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 highlyeffective method of contraception.
You likely can't join if
- 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 Bcell- 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
See the full eligibility 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 highlyeffective method of contraception.
- 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 Bcell- 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
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- United States
- Turkey
- United Kingdom
- Japan
- Canada
- Israel
- Australia
- China
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; United States; Turkey; United Kingdom; Japan; Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.