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New antibody aims to shield kidneys from autoimmune attack

NCT ID NCT06047171

Disease control Sponsor: Alentis Therapeutics AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Are male or female patients ≥18 years of age of any race or ethnicity with a score of \<7 on the Clinical Frailty Scale in the 3 months preceding the onset of RPGN attributed to AAV; Note: The PI should assess the Clinical Frailty Scale based on medical history and interview with the patient 2. Must be willing and able to comply with the study requirements and give informed consent for participation in the study; 3. Must be willing to have a renal biopsy procedure performed no later than prior to study drug administration at the Week 6 Visit; alternatively, a historical biopsy performed up to 45 days prior to the initiation of study drug administration is considered acceptable; 4. Have been newly diagnosed with RPGN within 45 days prior to the initiation of study drug treatment, as demonstrated by the following: - Evidence of loss of renal function with an eGFR of ≤50 mL/min/1.73 m2 and ≥10 mL/min/1.73 m2; and - History of proteinuria of any degree AND/OR hematuria that is temporally associated with the presenting episode of illness and supports the diagnosis of RPGN. Note: The hematuria may be represented by the presence of eumorphic or dysmorphic red blood cells (RBCs) and/or RBC casts. Patients with extrarenal manifestations of ANCA which started prior to RPGN should be discussed with the Medical Monitor and the Sponsor. 5. Are suspected of having RPGN attributed to AAV at Screening based on clinical laboratory diagnostic criteria, including a positive test for an ANCA, ie, anti-myeloperoxidase (MPO) or anti-proteinase 3 (PR3); 6. Have a body weight of ≤130 kg; 7. Female patients must not be pregnant or lactating at Screening and 1 of the following conditions must apply: - Is a female of childbearing potential and agrees to use a highly effective method of birth control during their participation in the study and for at least 5 half-lives or a minimum of 30 days after the last dose of study drug, or as recommended in the Summary of Product Characteristics (SmPC) of any authorized AxMP given as part of background standard of care (SOC) therapy, whichever is longer; or - Is a female of nonchildbearing potential. 8. Female patients must agree not to donate ova for 6 months after the last dose of study drug or as recommended in the SmPC of any authorized AxMP given as part of background SOC therapy, whichever is longer; 9. Male patients must agree to use contraception, in the form of either sexual abstinence or a condom, during their participation in the study and for 90 days after the last dose of study drug or as recommended in the SmPC of any authorized auxiliary medicinal product (AxMP) given as part of background SOC therapy, whichever is longer; and 10. Male patients must agree to abstain from sperm donation during their participation in the study and for 90 days after the last dose of study drug or as recommended in the SmPC of any authorized AxMP given as part of background SOC therapy, whichever is longer. Exclusion Criteria: 1. Have a history of previous RPGN that resolved or ameliorated (ie, the patient had a documented case of RPGN and has suffered a relapse); 2. Have a positive serology test for anti-glomerular basement membrane antibodies; 3. Have evidence of active or latent tuberculosis (TB) determined by a positive (not indeterminate) QuantiFERON®-TB Gold test (or equivalent). In countries where QuantiFERON®-TB Gold test (or equivalent) is not available, radiological criteria, including chest X-ray or computed tomography scan, may alternatively be used; 4. Have a chronic infection that could be exacerbated by RPGN or SOC therapy for RPGN; 5. Have active hepatitis B, hepatitis C, or HIV infection; 6. Have taken any prohibited medications. 7. Have received a course of SOC therapy which exceeds a high-dose prolonged regimen of treatment of ANCA RPGN, such as \>3000 mg of IV methylprednisolone-equipotent glucocorticoids, or \>1 mg/kg/day of oral glucocorticoids (prednisone equivalent) for \>14 days (doses are provided as a guidance for assessment of intensity; patients who received high-dose glucocorticoids should be discussed with and approved by the Medical Monitor and the Sponsor); Note: A course of systemic glucocorticoids attributed to extrarenal manifestation of ANCA should not be included in the assessment of Exclusion Criterion 7 and such occasions should be discussed with the Medical Monitor and the Sponsor. IV methylprednisolone administered as pre-medication for rituximab may be considered as prophylaxis of a potential hypersensitive response to rituximab. This pre-medication is allowed during the course of the study and will not account in the total dose calculation of the IV glucocorticoids threshold of 3000 mg at Screening for eligibility assessment. 8. Have been treated or planned to be treated with avacopan; 9. Have poor venous access; 10. Have participated in an investigational drug or device study and received investigational therapy \<30 days or 5 half lives, whichever is the greater, prior to the first dose of study drug. For biological investigational drugs, the exclusionary period may not be \<90 days prior to the first dose of study drug; 11. Have a history of psoriasis, AD, excessively dry skin or recurrent conjunctivitis that has required treatment prescribed by a physician, scleroderma, vitiligo, or any other active autoimmune dermatological disorder, with the exception of dermatological disorders or skin rashes that are attributable to, or known to be associated with, the underlying diagnosis of AAV, which shall not be exclusionary; 12. Have a diagnosis of systemic lupus erythematosus-AAV overlap syndrome; 13. Have a diagnosis of eosinophilic granulomatosis with polyangiitis; 14. Have evidence of uncontrolled respiratory, cardiac, hepatic, endocrine, central nervous system, or renal disease, unrelated to RPGN or AAV, that the PI believes cannot be readily brought under control, or any other medical condition that in the opinion of the PI renders the patient unsuitable for enrollment and could prevent the successful completion of the study; 15. Have received a live vaccine within 30 days prior to Screening; 16. Have received any vaccine within 7 days of the first dose of study drug other than against influenza or pneumococcal infection; 17. Are employed by the PI or the study site, have direct involvement in the proposed study or other studies under the direction of that PI, or are a family member of the PI or study site personnel; 18. Have not recovered from AEs and/or complications from major surgery prior to the first dose of study drug; Note: The PI should consult with the Medical Monitor and Sponsor to determine if ongoing, significant complications from major surgery are exclusionary. 19. Have active or known history of alcohol or substance abuse within 1 year prior to Day 1/Randomization or have a positive urine drug screen for drugs of abuse at Screening; 20. Have been diagnosed within the preceding 5 years with a malignant neoplastic disease, other than locally invasive cutaneous squamous or basal cell carcinoma; 21. Have alveolar haemorrhage with hypoxia defined by an oxygen saturation \<85% or that requires the use of invasive or noninvasive ventilatory support; 22. Have undergone dialysis within 7 days prior to Screening; 23. Have undergone therapeutic plasma exchange within 7 days prior to the first dose of study drug; or 24. Have known hypersensitivity to the study drug or any of the excipients used in the formulation of the study drug.

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis rapidly progressive glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glomerulonephritis rapidly progressive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    50 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM - Hopital de La Conception

    ACTIVE_NOT_RECRUITING

    Marseille, 13385, France

  • AP-HP Hopital Cochin

    RECRUITING

    Paris, 75014, France

  • AP-HP Hopital Pitie-Salpetriere

    RECRUITING

    Paris, 75013, France

  • APSS Ospedale Santa Chiara di Trento

    RECRUITING

    Trento, 38122, Italy

  • Aalborg University Hospital

    RECRUITING

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Ankara Etlik City Hospital

    RECRUITING

    Ankara, Keçiören, Turkey (Türkiye)

  • Azienda Ospedaliero-Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

  • CHRU de Brest - Hopital de la Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • CHU Bordeaux - Hopital Pellegrin

    RECRUITING

    Bordeaux, 33000, France

  • CHU Grenoble-Alpes - Hopital Michallon

    RECRUITING

    La Tronche, 38700, France

  • CHU de Nantes - Hotel-Dieu

    RECRUITING

    Nantes, 44000, France

  • CHU de Nimes

    RECRUITING

    Nîmes, 31000, France

  • CHU de Toulouse - Hopital Rangueil

    RECRUITING

    Toulouse, 31400, France

  • Cambridge University - Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Centre Hospitalier Boulogne sur Mer

    RECRUITING

    Boulogne-sur-Mer, Cedex, 62200, France

  • Centre Hospitalier de Valenciennes

    RECRUITING

    Valenciennes, 59300, France

  • Charite Universitaetsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Erciyes University Faculty of Medicine

    RECRUITING

    Melikgazi, Turkey (Türkiye)

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    RECRUITING

    Rome, 00168, Italy

  • Fundacio Puigvert

    RECRUITING

    Barcelona, 08025, Spain

  • Herlev Hospital

    ACTIVE_NOT_RECRUITING

    Herlev, 2730, Denmark

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 29001, Spain

  • Hospital Universitari Arnau de Vilanova

    RECRUITING

    Lleida, 25198, Spain

  • Hospital Universitari de Bellvitge

    RECRUITING

    Barcelona, 08907, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hôpital Fribourgeois-Freiburger Spital

    WITHDRAWN

    Villars-sur-Glâne, 1752, Switzerland

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, W21NY, United Kingdom

  • Inselspital, Universitaetsspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Institut klinicke a experimentalni mediciny

    RECRUITING

    Prague, 140 21, Czechia

  • Kantonsspital Baden AG

    RECRUITING

    Baden, 5404, Switzerland

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, 9000, Switzerland

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    RECRUITING

    München, 80802, Germany

  • Kocaeli University Medical School - Internal Medicine - Nephrology

    RECRUITING

    Kocaeli, Turkey (Türkiye)

  • Linkoping University Hospital

    RECRUITING

    Linköping, 581 85, Sweden

  • Manchester University NHS Foundation Trust (MFT)

    RECRUITING

    Manchester, United Kingdom

  • Marmara University Medical Faculty Hospital

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Medizinische Hochschule Hannover (MHH)

    RECRUITING

    Hanover, 30625, Germany

  • Odense University Hospital

    RECRUITING

    Odense, 5000, Denmark

  • Queen Elizabeth Hospital Birmingham

    RECRUITING

    Birmingham, B152GW, United Kingdom

  • Rigshospitalet

    RECRUITING

    Copenhagen, 56 2100, Denmark

  • Royal Free London NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, L78YE, United Kingdom

  • Royal Preston Hospital

    RECRUITING

    Preston, PR2 9HT, United Kingdom

  • Universitaetsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Koeln (AoeR)

    RECRUITING

    Cologne, 50931, Germany

  • Universitaetsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    RECRUITING

    Lübeck, 23562, Germany

  • University Hospital of Umea

    RECRUITING

    Umeå, 907 37, Sweden

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, 128 08, Czechia