At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
Imlifidasebiological
Likely dose
Imlifidase 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Phase II Study in Anti-GBM Disease (Goodpasture's Disease) With Adverse Renal Prognosis to Evaluate the Efficacy and Safety of IdeS - GOOD-IDES
In Brief
A Phase 2 clinical trial evaluating Imlifidase for Anti-Glomerular Basement Membrane Antibody Disease. Completed, enrolled 15 participants across 10 sites in 5 countries.
Detailed Summary
This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Czechia, Denmark, France, Sweden
CollaboratorsHansa Biopharma AB
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartJun 2017
Primary CompletionJul 2020
TodayJul 2026
First PostedMay 17, 2017
Enrollment StartJun 16, 2017
Primary CompletionJul 24, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.1 years ago
Interventions
Imlifidasebiological
One dose of 0.25 mg/kg body weight imlifidase on study day 1