Imlifidase for Goodpasture Syndrome

(GOOD-IDES-02 Trial)

Recruiting at 47 trial locations

Overseen By Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hansa Biopharma AB

Must not be taking: IVIg

Disqualifiers: Pregnancy, Breastfeeding, Anuria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have received IVIg (a type of immune therapy) within 4 weeks before joining, you cannot participate. It's best to discuss your current medications with the trial team.

Is Imlifidase safe for use in humans?

Imlifidase has been tested in a phase II trial for Goodpasture Syndrome, and among 15 patients, it helped 10 with severe kidney issues become dialysis independent after 6 months. This suggests it may be safe, but more research is needed to confirm its safety in humans. ^{1 2 3 4 5}

How does the drug Imlifidase differ from other treatments for Goodpasture Syndrome?

Imlifidase is unique because it rapidly breaks down IgG antibodies, which are involved in the immune response causing damage in Goodpasture Syndrome. This mechanism allows it to potentially reverse severe kidney failure and reduce the need for dialysis, offering a novel approach compared to standard treatments like plasma exchange and immunosuppressive drugs. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Clinical Operations

Principal Investigator

Hansa Biopharma AB

Eligibility Criteria

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.

Inclusion Criteria

I have antibodies that require a special blood filtering treatment.

My kidney function is severely reduced.

Blood in your urine.

Exclusion Criteria

Unsuitable to participate in the trial for any other reason in the opinion of the investigator

Patients previously randomised in the study

Pregnancy or breast feeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either imlifidase and SoC or SoC alone. Imlifidase is administered IV as one dose of 0.50 mg/kg over 30 minutes.

6 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety, renal function, anti-GBM antibody levels, and health-related quality of life.

18 months

Regular visits (in-person)

Treatment Details

Interventions

• Imlifidase

Trial Overview 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.

Participant Groups

Group I: Imlifidase and Standard-of-Care (SoC) Experimental Treatment 4 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 Control 3 Interventions

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

Who Is Running the Clinical Trial?

Hansa Biopharma AB

Lead Sponsor

Trials

20

Recruited

780+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Anti-glomerular basement membrane disease (Goodpasture disease): From pathogenesis to plasma exchange to IdeS. [2022]

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

Cutting edge issues in Goodpasture's disease. [2021]

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

Severe Relapsing Goodpasture's Disease Successfully Treated with Mycophenolate Mofetil. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

Penicillamine-induced "Goodpasture's syndrome": successful treatment of a fulminant case. [2021]

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

Use of combined plasmapheresis and immunosuppression in the treatment of Goodpasture's syndrome. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Imlifidase: First Approval. [2021]

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

Imlifidase Desensitization in HLA-incompatible Kidney Transplantation: Finding the Sweet Spot. [2023]

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

Imlifidase for the treatment of anti-HLA antibody-mediated processes in kidney transplantation. [2023]

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

Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). [2023]