Imlifidase for Goodpasture Syndrome

(GOOD-IDES-02 Trial)

Recruiting at47 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hansa Biopharma AB

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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

Treatment Details

Interventions

• Imlifidase (Enzyme)

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+