drugset / Trial / NCT05679401

A Study With Imlifidase in Anti-GBM Disease

NCT05679401 ↗

Phase 3 Terminated 50 enrolled Hansa Biopharma AB
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-12-22
Primary completion
2025-06-23
Completion
2026-02-02

Outcome

Missed primary endpoint

Stopped: “Company decision, not due to any safety reason.”

release “GOOD-IDES-02 said ”Although the trial did not meet the primary endpoint” hansabiopharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Imlifidase Protein / enzyme biologic 0.5 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified — —