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A Study With Imlifidase in Anti-GBM Disease

NCT05679401 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-04

No results posted yet for this study

Summary

An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and standard of care (SoC) with SoC alone. All patients will remain in the trial for 24 months.

Conditions

  • Anti-Glomerular Basement Membrane Disease
  • Anti-Glomerular Basement Membrane Antibody Disease
  • Goodpasture Syndrome
  • Good Pasture Syndrome

Interventions

DRUG

Imlifidase

Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.

PROCEDURE

Plasma exchange (PLEX)

PLEX removes the patient's pathogenic anti-GBM antibodies, by replacement of deficient plasma with a replacement fluid.

DRUG

Cyclophosphamide (CYC)

Cyclophosphamide's main mechanism of action (i.e. crosslinking of strands of DNA and RNA) results in inhibition of protein synthesis. Hence treatment prevents formation of new anti-GBM antibodies.

DRUG

Glucocorticoids

Glucocorticoids inhibit the inflammation process.

Sponsors & Collaborators

  • Hansa Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Clinical Operations · Hansa Biopharma AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2025-06-23
Completion
2026-02-02
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05679401 on ClinicalTrials.gov