Inebilizumab for IgG4-Related Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called inebilizumab (also known as Uplizna or inebilizumab-cdon) to determine if it can prevent flare-ups in people with IgG4-related disease (IgG4-RD), a condition where the immune system attacks various body parts. Researchers aim to assess whether inebilizumab is safe and effective in stopping these flares. Participants will receive either inebilizumab or a placebo (a treatment with no active drug) through an IV infusion. Those diagnosed with IgG4-RD and who have experienced recent flare-ups requiring steroid treatment may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot have received certain treatments like biologic B cell-depleting therapy in the 6 months before screening or non-biologic DMARDs within 4 weeks before screening.
Is there any evidence suggesting that inebilizumab is likely to be safe for humans?
Research has shown that inebilizumab is generally well-tolerated by people with IgG4-related disease, a condition causing inflammation in various parts of the body. Studies have found that urinary tract infections are the most common side effect, occurring in at least 10% of patients. These side effects occurred more frequently compared to those who received a placebo, a substance with no active medication. Additionally, inebilizumab has been shown to lower the risk of disease flare-ups and help maintain reduced or absent symptoms for up to a year. This suggests that while some side effects exist, the treatment could offer significant benefits for managing IgG4-related disease.12345
Why do researchers think this study treatment might be promising for IgG4-related disease?
Unlike standard treatments for IgG4-Related Disease, which often include corticosteroids and immunosuppressants, inebilizumab is unique because it specifically targets CD19, a protein found on the surface of B cells, which are a type of immune cell involved in the disease. This targeted approach can potentially reduce inflammation and tissue damage more effectively. Researchers are excited about inebilizumab because it offers a new mechanism of action that could improve outcomes for patients who do not respond well to existing therapies.
What evidence suggests that inebilizumab might be an effective treatment for IgG4-RD?
Research has shown that inebilizumab, which participants in this trial may receive, effectively treats IgG4-related disease (IgG4-RD). In one study, about 59% of patients who took inebilizumab achieved complete remission without needing steroids, compared to only 22% of those who received a placebo. This indicates that patients did not experience flare-ups or require extra medication. Inebilizumab reduces the chance of disease flare-ups, increasing the likelihood of patients remaining in remission for over a year. This approach holds promise for managing IgG4-RD by controlling symptoms without additional medication.35678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Adults over 18 with IgG4-Related Disease affecting at least two organs and needing glucocorticoid treatment can join. They must meet specific criteria, use effective contraception if of childbearing potential, and not have used certain drugs or had live vaccines recently. Those with recent malignancies or severe kidney issues are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomized Control Period (RCP)
Participants receive intravenous inebilizumab or placebo for 52 weeks, with initial glucocorticoid tapering and treatment of flares
Safety Follow-up Period (SFUP)
Participants are monitored for safety after discontinuation of investigational product
Open-label Period (OLP)
Optional continuation of inebilizumab treatment for eligible participants
What Are the Treatments Tested in This Trial?
Interventions
- Inebilizumab
Inebilizumab is already approved in United States, European Union, Canada for the following indications:
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
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Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Viela Bio (acquired by Horizon Therapeutics)
Lead Sponsor
Viela Bio
Lead Sponsor