A Study With Imlifidase in Anti-GBM Disease
Stopped early · Phase 3
Conditions studied: Anti-Glomerular Basement Membrane Disease, Anti-Glomerular Basement Membrane Antibody Disease, Goodpasture Syndrome, Good Pasture Syndrome
In brief
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.
Key facts
- Study ID
- NCT05679401
- Run by
- Hansa Biopharma AB
- People needed
- 50
- Starts
- 2022-12-22
- Expected to finish
- 2026-02-02
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Anti-GBM antibodies constituting an indication for PLEX as judged by the Investigator
- Haematuria on dipstick and/or urinary sediment
- eGFR(MDRD) <20 mL/min/1.73 m\^2
- Patients aged ≥18 years
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
You may not qualify if…
- Diagnosis of anti-GBM disease more than 14 days prior to randomisation
- Anuria during the last 24-hour
- Any constituent of SoC given more than 10 days prior to randomisation
- IVIg within 4 weeks before randomisation
- History or presence of any medical condition or disease which, in the opinion of the investigator, may place the patient at unacceptable risk, or jeopardise the purpose of the study
- Patients previously randomised in the study
- Unsuitable to participate in the trial for any other reason in the opinion of the investigator
- Pregnancy or breast feeding
- Contraception:
- Men who are not vasectomised or abstinent or with a partner (of child-bearing potential) not willing to use one of the highly effective contraceptives listed below from screening to 6 months following discontinuation of CYC
- Men who are not willing to refrain from donating sperm from screening to 6 months following discontinuation of CYC
- Men who are not willing to use a condom during any form of sexual intercourse, regardless of a partner being of child-bearing potential from screening to 6 months following discontinuation of CYC
- Women of child-bearing potential not willing or not able to use at least one highly effective contraceptive method from screening to 12 months following discontinuation of CYC.
- In the context of this trial, a highly effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as:
- combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable)
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- true abstinence: When this is in line with the preferred and usual lifestyle of the patient. [Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
- Previous imlifidase treatment or known hypersensitivity to any of the excipients
Where it is running
- UCLA Medical Center Plaza — Los Angeles, California, United States
- John Hopkins Medical Institution — Baltimore, Maryland, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- University of Minnesota Health Clinical Research Unit — Minneapolis, Minnesota, United States
- UNC Kidney Center/Division of Nephrology & Hypertension — Chapel Hill, North Carolina, United States
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Med Uni Graz / LKH-UNIV Klinikum Graz, Klinische Abteilung fuer Nephrologie — Graz, Stiermark, Austria
- Medical University Innsbruck, Dept of Internal Medicine IV (Nephrology and Hypertension) — Innsbruck, Tyrol, Austria
- Medical University of Vienna, Dept of Medicine III, Division of Nephrology and dialysis — Vienna, Austria
- UZ Leuven — Leuven, Belgium
- Všeobecná fakultní nemocnice v Praze — Prague, Prague, Czechia
- Aarhus University Hospital, Renal Medicine and Clinical Medicine — Aarhus N, Central Jutland, Denmark
- Odense University Hospital, Medical Nephrology, Department Y — Odense, Region Syddanmark, Denmark
- Rigshospitalet, Department of Nephrology — Copenhagen, Denmark
- CHU Grenoble Alpes - Michallon Hospital, Nephrology, Hemodialysis, Apheresis and Kidney Transplantation — Grenoble, Auvergne-Rhône-Alpes, France
- University Hospital of Marseille, Nephrology - Renal transplantation service — Marseille, Bouches-du-Rhône, France
- Nouvel Hôpital Civil (University Hospital of Strasbourg) — Strasbourg, Grand Est, France
- CHU Lille. Nephrology, dialysis transplantation — Lille, Haus-de-France, France
- CHU Bordeaux, Hôpital Pellegrin, Service nephrologie, transplantation, dialyse, aphereses — Bordeaux, New Aquitaine, France
- CHU de Rouen, Department of Nephrology,Transplantation, and Hemodialysis — Bois-Guillaume, Normandy, France
- Hôpital Rangueil, CHU de Toulouse, Department of Nephrology and Organ transplantation — Toulouse, Occitanie, France
- CHU de Nantes, Hôtel-Dieu, Le service de néphrologie et immunologie clinique — Nantes, Pays de la Loire Region, France
- Tenon Hospital, Renal intensive care unit — Paris, Île-de-France Region, France
- LMU Klinikum, Medical Clinic IV / Department of Nephrology — Munich, Bavaria, Germany
- Uniklinik RWTH Aachen — Aachen, North Rhine-Westphalia, Germany
Full record on ClinicalTrials.gov
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