NCT05679401

A Study With Imlifidase in Anti-GBM Disease

A Phase 3 Open-label, Controlled, Randomised, Multi-centre Trial Comparing Imlifidase and Standard-of-care With Standard-of-care Alone in the Treatment of Severe Anti-GBM Antibody Disease (Goodpasture Disease)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hansa Biopharma AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patients will be randomised to treatment in a 1:1 ratio to either imlifidase and SoC or SoC only. SoC consists of a combination of plasma exchange (PLEX), cyclophosphamide (CYC), and glucocorticoids. For patients randomised to the imlifidase arm the first PLEX immediately after randomisation is replaced by administration of imlifidase. Kidney function, anti-GBM antibody levels, pulmonary symptoms, safety, pharmacokinetic/pharmacodynamic (PK/PD) and health related quality of life (HRQoL) among others, will be assessed.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-22
• Primary completion: 2025-06-23
• Completion: 2026-02-02
• First posted: 2023-01-11
• Last updated: 2026-03-04

Locations

48 sites across 13 countries: United States, Austria, Belgium, Czechia, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study