Inebilizumab for IgG4-Related Disease

Recruiting at 74 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

135 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Inebilizumab for IgG4-Related Disease?

Inebilizumab is being studied for its ability to reduce flares in IgG4-Related Disease by targeting and depleting specific immune cells (CD19+ B cells) involved in the disease. Similar treatments, like rituximab, have shown effectiveness in managing IgG4-Related Disease, suggesting that targeting B cells can be beneficial. ^{1 2 3 4 5}

How is the drug Inebilizumab different from other treatments for IgG4-Related Disease?

Inebilizumab is unique because it targets CD19, a protein on B cells, to deplete these cells, which are thought to play a role in IgG4-Related Disease. This approach is different from the standard treatment with glucocorticoids, which can have significant side effects. ^{1 2 5 6 7}

What is the purpose of this trial?

This trial tests if inebilizumab, an IV medication, can prevent flare-ups in patients with IgG4-RD who are at high risk. It works by reducing immune cells that cause inflammation and damage.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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 taken non-biologic DMARDs or immunosuppressants, except for GCs, in the last 4 weeks.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

The association of different serum IgG4 levels with distinct clinical characteristics and treatment efficacy in patients with IgG4-related disease. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Protocol for a Randomized Controlled Trial. [2023]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Rituximab for IgG4-related disease: a prospective, open-label trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinicoserological factors associated with response to steroid treatment and recurrence in patients with IgG4-related ophthalmic disease. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Successful remission induction of IgG4-related ophthalmic disease by obinutuzumab therapy: a retrospective study of 8 patients. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The external validation of the 2019 ACR/EULAR classification criteria for IgG4-related disease in a large cohort from China. [2023]