Imlifidase

DRUG14 trials

Sponsors

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer, Mårten Segelmark, Hansa Biopharma AB, Sarepta Therapeutics, Inc., Fundacion Clinic per a la Recerca Biomédica

Conditions

Anti-Glomerular Basement Membrane Antibody DiseaseAnti-Glomerular Basement Membrane DiseaseCrigler-Najjar SyndromeDuchenne Muscular DystrophyGood Pasture SyndromeGoodpasture SyndromeGuillain-Barré Syndrome (GBS)Kidney Transplant Candidates

Phase 1

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)

TerminatedNCT06241950

Sarepta Therapeutics, Inc.Duchenne Muscular Dystrophy

Start: 2024-01-29End: 2025-10-10Updated: 2025-11-20

Phase 2

Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease

CompletedNCT03157037

Mårten SegelmarkAnti-Glomerular Basement Membrane Antibody Disease

Start: 2017-06-16End: 2020-07-24Updated: 2022-04-07

An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

CompletedNCT03897205

Hansa Biopharma ABKidney Transplant Rejection

Start: 2019-04-30End: 2022-11-16Updated: 2024-02-28

A Study of Imlifidase in Patients With Guillain-Barré Syndrome

CompletedNCT03943589

Hansa Biopharma ABGuillain-Barré Syndrome (GBS)

Start: 2019-11-12End: 2024-02-27Updated: 2025-04-09

A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation

TerminatedNCT05049850

Hansa Biopharma ABKidney Transplantation in Highly Sensitized Patients

Start: 2022-12-16End: 2024-05-08Updated: 2025-10-21

Imlifidase Prior to Kidney Transplant in Highly Sensitised Children

RecruitingNCT05753930

Hansa Biopharma ABKidney Transplantation in Highly Sensitized Patients

Start: 2023-06-02End: 2031-08-31Target: 10Updated: 2025-02-06

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients

WithdrawnNCT06461546

Fundacion Clinic per a la Recerca BiomédicaKidney Transplant Candidates

Start: 2024-10-22End: 2027-05-31Updated: 2025-03-12

Efficacy and Safety of GNT0003 Following Imlifidase Pre-treatment in Severe Crigler-Najjar Syndrome

RecruitingNCT06518005

GenethonCrigler-Najjar Syndrome

Start: 2024-11-08End: 2030-09-30Target: 3Updated: 2024-12-03

IMLIFIDASE IN LIVING DONOR RENAL TRANSPLANTATION: HIGHLY SENSITIZED RECIPIENTS (LIVEDES STUDY)

CompletedCTIS2024-513607-14-00

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyerkidney trasplant

End: 2024-12-03Target: 10Updated: 2024-10-22

Phase 3

Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx

CompletedNCT04935177

Hansa Biopharma ABKidney Transplantation in Highly Sensitized Patients

Start: 2021-10-14End: 2025-06-20Updated: 2025-07-16

Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts

Active, not recruitingNCT05369975

Hansa Biopharma ABKidney Transplantation in Highly Sensitized Patients

Start: 2022-04-19End: 2026-04-30Target: 225Updated: 2025-03-18

A Study With Imlifidase in Anti-GBM Disease

TerminatedNCT05679401

Hansa Biopharma ABAnti-Glomerular Basement Membrane Antibody Disease, Anti-Glomerular Basement Membrane Disease, Goodpasture Syndrome +1

Start: 2022-12-22End: 2026-02-02Updated: 2026-03-04

Unknown Phase

A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

CompletedNCT03611621

Hansa Biopharma ABKidney Transplant Failure and Rejection

Start: 2018-06-27End: 2023-02-14Updated: 2025-02-07

An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR

TerminatedNCT04711850

Hansa Biopharma ABKidney Transplant Rejection

Start: 2021-01-20End: 2023-03-30Updated: 2025-05-28

Related Papers

Five Years Follow-up of Imlifidase Desensitized Kidney Transplant Recipients.

2025-11-27

Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization

Transplantation Direct2025-01-093 citations

AAV gene therapy for Duchenne muscular dystrophy: the EMBARK phase 3 randomized trial

Nature Medicine2024-10-09103 citations

A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody‐Mediated Rejection

Clinical Transplantation2024-07-0116 citations

Using imlifidase to elucidate the characteristics and importance of anti-GBM antibodies produced after start of treatment

Nephrology Dialysis Transplantation2023-06-299 citations

Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients.

2021-07-1967 citations