6 completed, 4 terminated, 2 recruiting, 1 withdrawn. 7 Phase 2, 3 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 3, Recruiting 2, Terminated 1, Withdrawn 1 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
| Phase 1 | 1 | Terminated 1 |
Follow Imlifidase: new trials by email Literature Review of Imlifidase trials Research Report on Imlifidase
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of GNT0003 Following Imlifidase Pre-treatment in Severe Crigler-Najjar Syndrome Imlifidase, GNT0003 - Crigler-Najjar Syndrome | Phase 2 | Recruiting | Genethon | 3 | 2024-11-08 | 2024-12-03 |
| Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients Imlifidase - Kidney Transplant Candidates | Phase 2 | Withdrawn | Fundacion Clinic per a la Recerca Biomédica | 2024-10-22 | 2025-03-12 | |
| A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74) delandistrogene moxeparvovec, imlifidase - Duchenne Muscular Dystrophy | Phase 1 | Terminated | Sarepta Therapeutics, Inc. | 5 | 2024-01-29 | 2025-11-20 |
| Imlifidase Prior to Kidney Transplant in Highly Sensitised Children Imlifidase - Kidney Transplantation in Highly Sensitized Patients | Phase 2 | Recruiting | Hansa Biopharma AB | 10 | 2023-06-02 | 2026-08-18 |
| A Study With Imlifidase in Anti-GBM Disease Imlifidase, Plasma exchange (PLEX), Cyclophosphamide (CYC) - Anti-Glomerular Basement Membrane Disease, Anti-Glomerular Basement Membrane Antibody Disease | Phase 3 | Terminated | Hansa Biopharma AB | 50 | 2022-12-22 | 2026-03-04 |
| A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation Imlifidase - Kidney Transplantation in Highly Sensitized Patients | Phase 2 | Terminated | Hansa Biopharma AB | 3 | 2022-12-16 | 2025-10-21 |
| Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts Imlifidase, Normal Transplantation Routine - Kidney Transplantation in Highly Sensitized Patients | Phase 3 | Completed | Hansa Biopharma AB | 113 | 2022-04-19 | 2026-05-05 |
| Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx Imlifidase, PLEX, IVIg - Kidney Transplantation in Highly Sensitized Patients | Phase 3 | Completed | Hansa Biopharma AB | 64 | 2021-10-14 | 2026-04-30 |
| An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR Imlifidase - Kidney Transplant Rejection | Terminated | Hansa Biopharma AB | 18 | 2021-01-20 | 2025-05-28 | |
| A Study of Imlifidase in Patients With Guillain-Barré Syndrome Imlifidase - Guillain-Barré Syndrome (GBS) | Phase 2 | Completed | Hansa Biopharma AB | 30 | 2019-11-12 | 2025-04-09 |
| An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients Imlifidase, Plasma Exchange - Kidney Transplant Rejection | Phase 2 | Completed | Hansa Biopharma AB | 30 | 2019-04-30 | 2024-02-28 |
| A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation Imlifidase - Kidney Transplant Failure and Rejection | Completed | Hansa Biopharma AB | 31 | 2018-06-27 | 2025-02-07 | |
| Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease Imlifidase - Anti-Glomerular Basement Membrane Antibody Disease | Phase 2 | Completed | Mårten Segelmark | 15 | 2017-06-16 | 2022-04-07 |
Kidney Failure, Chronic (2) · Rapidly progressive glomerulonephritis with pulmonary hemorrhage (2) · Anti-Glomerular Basement Membrane Disease (1) · Crigler-Najjar Syndrome (1) · Guillain-Barre Syndrome (1) · Muscular Dystrophy, Duchenne (1) · Rejection, Psychology (1)
Hansa Biopharma AB (9) · Fundacion Clinic per a la Recerca Biomédica (1) · Genethon (1) · Mårten Segelmark (1) · Sarepta Therapeutics, Inc. (1)
France (9) · Austria (5) · Sweden (5) · United States (5) · Germany (4) · Spain (4) · United Kingdom (4) · Czechia (3) · Netherlands (3) · Belgium (2) · Denmark (2) · Italy (2) · Australia (1) · Finland (1) · Ireland (1)
PMID 39023092, PMID 37385828, PMID 38995690, PMID 41394519
2018 (1)