What is the mechanism of action of this treatment?

Goodpasture Syndrome treatments primarily focus on reducing pathogenic antibodies and suppressing the immune response. Plasmapheresis removes circulating antibodies, while immunosuppressive drugs like cyclophosphamide and prednisolone reduce new antibody production and dampen the immune response. Imlifidase, an enzyme that cleaves IgG antibodies, offers a novel approach by rapidly reducing pathogenic antibody levels, potentially halting kidney damage progression more quickly than traditional therapies. This rapid action is crucial for preventing severe kidney damage in Goodpasture Syndrome patients.

What side effects are associated with this type of intervention?

Goodpasture Syndrome treatments often involve corticosteroids, cyclophosphamide, and plasmapheresis. Corticosteroids can cause weight gain, hypertension, diabetes, osteoporosis, and infections. Cyclophosphamide may lead to bone marrow suppression, infections, hemorrhagic cystitis, and malignancy. Plasmapheresis can result in hypotension, allergic reactions, and infections. Imlifidase, an enzyme that cleaves IgG antibodies, is being studied for severe anti-GBM disease and may cause infusion-related reactions and increased infection risk.

What prior FDA approvals exist?

Goodpasture Syndrome, or anti-GBM disease, is primarily treated with plasmapheresis, cyclophosphamide, and glucocorticoids, which are standard therapies aimed at reducing antibody levels and suppressing the immune response. Rituximab, an FDA-approved monoclonal antibody for other autoimmune conditions, is sometimes used as an alternative, though not as first-line therapy. Mycophenolate mofetil is another alternative but lacks sufficient evidence for first-line use. These treatments focus on reducing the pathogenic effects of antibodies, similar to the mechanism of Imlifidase, which cleaves IgG antibodies.

What other types of research exist?

Promising, novel alternatives to Imlifidase for Goodpasture Syndrome patients include rituximab and mycophenolate mofetil (MMF). These therapies are considered when cyclophosphamide is not suitable, although they are not first-line treatments due to limited evidence.

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Enzyme

Imlifidase for Goodpasture Syndrome (GOOD-IDES-02 Trial)

Phase 3

Recruiting

Research Sponsored by Hansa Biopharma AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

eGFR(MDRD) <20 mL/min/1.73 m^2

Patients aged ≥18 years

Must not have

Anuria during the last 24-hour

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at screening and at 6 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests imlifidase, a drug that breaks down harmful antibodies, in patients with severe anti-GBM disease. The goal is to see if it improves kidney function. Imlifidase is conditionally approved in the EU for use in certain kidney transplant patients.

Who is the study for?

This trial is for adults over 18 with severe anti-GBM disease, indicated by specific kidney function tests and presence of certain antibodies. They must have blood in their urine and not have been treated with standard care or immune globulins recently. Pregnant or breastfeeding individuals, those with conditions posing extra risks, or anuria (no urine output) in the last day are excluded.

What is being tested?

The study compares a new treatment approach using Imlifidase alongside standard therapies like plasma exchange, cyclophosphamide, and glucocorticoids against the standard treatments alone. It's designed to see if adding Imlifidase improves kidney function in patients with anti-GBM disease over two years.

What are the potential side effects?

Imlifidase may cause allergic reactions, infections due to weakened immunity from plasma exchange and immunosuppressive drugs like cyclophosphamide and glucocorticoids can lead to increased infection risk, bleeding issues, bone marrow suppression, nausea/vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is severely reduced.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not urinated in the last 24 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening and at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening and at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Anti-imlifidase antibody levels from start of imlifidase treatment to 6 months

Change in health related quality of life (HRQoL) from screening to 6 months

Change in health status from screening to 6 months

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Imlifidase and Standard-of-Care (SoC)Experimental Treatment4 Interventions

* Imlifidase is administered IV as one dose of 0.50 mg/kg over 30 minutes. * SoC consists of a standardized combination of PLEX, CYC, and glucocorticoids.

Group II: Standard-of-Care (SoC)Active Control3 Interventions

SoC consists of a standardized combination of PLEX, CYC, and glucocorticoids.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glucocorticoids

2011

Completed Phase 4

~1310

Plasma exchange (PLEX)

2012

N/A

~10

Imlifidase

2017

Completed Phase 2

~80

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Goodpasture Syndrome treatments primarily focus on reducing pathogenic antibodies and suppressing the immune response. Plasmapheresis removes circulating antibodies, while immunosuppressive drugs like cyclophosphamide and prednisolone reduce new antibody production and dampen the immune response. Imlifidase, an enzyme that cleaves IgG antibodies, offers a novel approach by rapidly reducing pathogenic antibody levels, potentially halting kidney damage progression more quickly than traditional therapies. This rapid action is crucial for preventing severe kidney damage in Goodpasture Syndrome patients.

Pulmonary Alveolar Proteinosis Refractory to Plasmapheresis and Rituximab despite GM-CSF Antibody Reduction.A review of imlifidase in solid organ transplantation.Refractory secondary thrombotic microangiopathy with kidney injury associated with systemic lupus erythematosus in a pediatric patient.