Inebilizumab for IgG4-Related Disease

Not currently recruiting at 84 trial locations

Overseen By Horizon Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must be taking: Glucocorticoids

Must not be taking: Biologic B cell-depleting

Disqualifiers: Transplantation, Malignancy, Tuberculosis, Hepatitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

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. ^{3 5 6 7 8}

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

Fulfillment of the 2019 ACR/EULAR classification criteria

I need steroids for my IgG4-related disease flare-up.

I am using effective birth control as I could get pregnant.

Exclusion Criteria

My kidney function is severely reduced.

I haven't had an active cancer except for certain types of cervical, skin, or prostate cancer in the last 10 years.

I haven't taken non-biologic DMARDs or immunosuppressants, except for GCs, in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Randomized Control Period (RCP)

Participants receive intravenous inebilizumab or placebo for 52 weeks, with initial glucocorticoid tapering and treatment of flares

52 weeks

Safety Follow-up Period (SFUP)

Participants are monitored for safety after discontinuation of investigational product

104 weeks

Open-label Period (OLP)

Optional continuation of inebilizumab treatment for eligible participants

156 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inebilizumab

Trial Overview

The trial is testing Inebilizumab's ability to prevent flares in IgG4-Related Disease compared to a placebo. Participants will be randomly assigned to receive either the drug or a placebo to assess effectiveness and safety.

How Is the Trial Designed?

Group I: VIB0551 Experimental Treatment 1 Intervention

Inebilizumab administered as an IV infusion.

Group II: Placebo Placebo Group 1 Intervention

Placebo administered as an IV infusion.

Inebilizumab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Uplizna for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Approved in European Union as Uplizna for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Approved in Canada as Uplizna for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

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

Trials

7

Recruited

950+

Viela Bio

Lead Sponsor

Trials

13

Recruited

1,100+

Published Research Related to This Trial

Rituximab (RTX) was found to be highly effective in treating IgG4-related disease (IgG4-RD), with a clinical response observed in 93.5% of symptomatic patients, and over half of the patients able to withdraw from glucocorticoids after treatment.

However, relapses occurred in 41.9% of responders, and maintenance therapy with RTX was linked to longer relapse-free survival, although the treatment was associated with a significant risk of severe infections and temporary effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of rituximab in IgG4-related disease: Data from a French nationwide study of thirty-three patients. Ebbo, M., Grados, A., Samson, M., et al.[2022]

In a pilot trial involving 30 patients with IgG4-related disease, rituximab (RTX) demonstrated a high efficacy, with 97% of participants showing disease response and 77% achieving the primary outcome after 6 months.

The treatment led to significant reductions in disease activity scores and serum IgG4 levels, with 47% of patients reaching complete remission at 6 months, indicating RTX's potential as an effective therapy even without glucocorticoid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab for IgG4-related disease: a prospective, open-label trial. Carruthers, MN., Topazian, MD., Khosroshahi, A., et al.[2022]

Citations

1.

upliznahcp.com

upliznahcp.com/igg4-rd/clinical-results/efficacy

IgG4-RD Efficacy| UPLIZNA® (inebilizumab-cdon) for HCPs

40 out of 68 patients on UPLIZNA (58.8%) achieved steroid-free, flare-free complete remission vs 15 out of 67 patients on placebo (22.4%) at week 52.

2.

uplizna.com

uplizna.com/igg4-rd/about-uplizna/results

IgG4-RD Results

About 60% of patients on UPLIZNA (40 of 68) achieved steroid-free complete remission† compared to 22% on placebo (15 of 67) over 52 weeks.‡. *Placebo is a ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39541094/

Inebilizumab for Treatment of IgG4-Related Disease

Inebilizumab reduced the risk of flares of IgG4-related disease and increased the likelihood of flare-free complete remission at 1 year, ...

4.

nejm.org

nejm.org/doi/10.1056/NEJMoa2409712

Inebilizumab for Treatment of IgG4-Related Disease

Inebilizumab reduced the risk of flares of IgG4-related disease and increased the likelihood of flare-free complete remission at 1 year, ...

5.

amgen.com

amgen.com/newsroom/press-releases/2025/04/uplizna-inebilizumabcdon-is-now-the-first-and-only-fdaapproved-treatment-for-igg4related-disease

UPLIZNA® (INEBILIZUMAB-CDON) IS NOW THE FIRST ...

This trial demonstrated the potential of UPLIZNA to decrease disease activity by reducing flares in patients, while maintaining its efficacy and ...

6.

upliznahcp.com

upliznahcp.com/igg4-rd/clinical-results/safety

IgG4-RD Safety | UPLIZNA® (inebilizumab-cdon) for HCPs

The most common adverse reactions in IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infections and ...

7.

uplizna.com

uplizna.com/igg4-rd/about-uplizna/safety

IgG4-RD Safety

View the established safety profile for UPLIZNA® (inebilizumab-cdon), including safety data from the first and only IgG4-RD patient study.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04540497

NCT04540497 | A Study of Inebilizumab Efficacy and ...

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