New antibody aims to shield kidneys from autoimmune attack
NCT ID NCT06047171
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether adding ALE.F02 to standard therapy can protect kidney function in people with ANCA-associated vasculitis, an autoimmune disease that attacks small blood vessels, often damaging the kidneys. About 80 participants will receive either a low, high, or maximum dose of ALE.F02, or a placebo, alongside standard treatment. The study focuses on safety and whether the drug helps preserve kidney function over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
ALE.F02 (a monoclonal antibody targeting Claudin-1)
What this could lead to
If successful, ALE.F02 could help preserve kidney function in people with ANCA-associated vasculitis, reducing the need for dialysis or transplant.
What could go wrong
This is an early Phase 2 trial with only 80 participants. The drug may not show benefit, or could cause unexpected side effects. It is not a cure.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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AP-HP Hopital Cochin
RECRUITINGParis, 75014, France
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AP-HP Hopital Pitie-Salpetriere
RECRUITINGParis, 75013, France
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APSS Ospedale Santa Chiara di Trento
RECRUITINGTrento, 38122, Italy
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Aalborg University Hospital
RECRUITINGAalborg, 9000, Denmark
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Aarhus University Hospital
RECRUITINGAarhus, 8200, Denmark
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Ankara Etlik City Hospital
RECRUITINGAnkara, Keçiören, Turkey (Türkiye)
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Azienda Ospedaliero-Universitaria Careggi
RECRUITINGFlorence, 50134, Italy
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Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
RECRUITINGBergamo, 24127, Italy
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CHRU de Brest - Hopital de la Cavale Blanche
RECRUITINGBrest, 29200, France
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CHU Bordeaux - Hopital Pellegrin
RECRUITINGBordeaux, 33000, France
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CHU Grenoble-Alpes - Hopital Michallon
RECRUITINGLa Tronche, 38700, France
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CHU de Nantes - Hotel-Dieu
RECRUITINGNantes, 44000, France
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CHU de Nimes
RECRUITINGNîmes, 31000, France
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CHU de Toulouse - Hopital Rangueil
RECRUITINGToulouse, 31400, France
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Cambridge University - Addenbrooke's Hospital
RECRUITINGCambridge, CB2 0QQ, United Kingdom
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Centre Hospitalier Boulogne sur Mer
RECRUITINGBoulogne-sur-Mer, Cedex, 62200, France
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Centre Hospitalier de Valenciennes
RECRUITINGValenciennes, 59300, France
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Charite Universitaetsmedizin Berlin
RECRUITINGBerlin, 10117, Germany
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Erciyes University Faculty of Medicine
RECRUITINGMelikgazi, Turkey (Türkiye)
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Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
RECRUITINGRome, 00168, Italy
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Fundacio Puigvert
RECRUITINGBarcelona, 08025, Spain
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Hospital Regional Universitario de Malaga
RECRUITINGMálaga, 29001, Spain
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Hospital Universitari Arnau de Vilanova
RECRUITINGLleida, 25198, Spain
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Hospital Universitari de Bellvitge
RECRUITINGBarcelona, 08907, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
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Hôpital Fribourgeois-Freiburger Spital
WITHDRAWNVillars-sur-Glâne, 1752, Switzerland
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IRCCS Ospedale San Raffaele
RECRUITINGMilan, 20132, Italy
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Imperial College Healthcare NHS Trust
RECRUITINGLondon, W21NY, United Kingdom
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Inselspital, Universitaetsspital Bern
RECRUITINGBern, 3010, Switzerland
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Institut klinicke a experimentalni mediciny
RECRUITINGPrague, 140 21, Czechia
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Kantonsspital Baden AG
RECRUITINGBaden, 5404, Switzerland
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Kantonsspital St. Gallen
RECRUITINGSankt Gallen, 9000, Switzerland
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Klinikum der Ludwig-Maximilians-Universitaet Muenchen
RECRUITINGMünchen, 80802, Germany
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Kocaeli University Medical School - Internal Medicine - Nephrology
RECRUITINGKocaeli, Turkey (Türkiye)
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Linkoping University Hospital
RECRUITINGLinköping, 581 85, Sweden
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Marmara University Medical Faculty Hospital
RECRUITINGIstanbul, Turkey (Türkiye)
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Medizinische Hochschule Hannover (MHH)
RECRUITINGHanover, 30625, Germany
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Odense University Hospital
RECRUITINGOdense, 5000, Denmark
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Queen Elizabeth Hospital Birmingham
RECRUITINGBirmingham, B152GW, United Kingdom
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Rigshospitalet
RECRUITINGCopenhagen, 56 2100, Denmark
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Royal Liverpool University Hospital
RECRUITINGLiverpool, L78YE, United Kingdom
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Royal Preston Hospital
RECRUITINGPreston, PR2 9HT, United Kingdom
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Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITINGDresden, 01307, Germany
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Universitaetsklinikum Essen
RECRUITINGEssen, 45147, Germany
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Universitaetsklinikum Koeln (AoeR)
RECRUITINGCologne, 50931, Germany
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Universitaetsklinikum Leipzig
RECRUITINGLeipzig, 04103, Germany
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Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
RECRUITINGLübeck, 23562, Germany
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University Hospital of Umea
RECRUITINGUmeå, 907 37, Sweden
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Vseobecna fakultni nemocnice v Praze
RECRUITINGPrague, 128 08, Czechia