Glomerulonephritis Rapidly ProgressivePhase 2RENAL-F02NCT06047171
Rescue of Nephrons With ALE.F02 (RENAL-F02)
A Phase 2 study testing ALE.F02, Rituximab and GlucoCorticoid in people with Glomerulonephritis Rapidly Progressive, run by Alentis Therapeutics AG at 53 sites in 10 countries.
Trial summary
The goal of this clinical trial is to learn if a new drug that might help protect and preserve kidney function in antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glomerulonephritis Rapidly Progressive
- What is being tested?
- ALE.F02, Rituximab and GlucoCorticoid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 53 sitesin 10 countries
- Study dates
- 7 Sep 2023to 28 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Must be willing and able to comply with the study requirements and give informed consent for participation in the study;
- 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;
- 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.
- 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);
- Have a body weight of ≤130 kg;
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- 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.
- 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;
- 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
- 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.
Who cannot join
- Have a history of previous RPGN that resolved or ameliorated (ie, the patient had a documented case of RPGN and has suffered a relapse);
- Have a positive serology test for anti-glomerular basement membrane antibodies;
- 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;
- Have a chronic infection that could be exacerbated by RPGN or SOC therapy for RPGN;
- Have active hepatitis B, hepatitis C, or HIV infection;
- Have taken any prohibited medications.
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- 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.
- Have been treated or planned to be treated with avacopan;
- Have poor venous access;
- 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;
- 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;
- Have a diagnosis of systemic lupus erythematosus-AAV overlap syndrome;
- Have a diagnosis of eosinophilic granulomatosis with polyangiitis;
- 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;
- Have received a live vaccine within 30 days prior to Screening;
- Have received any vaccine within 7 days of the first dose of study drug other than against influenza or pneumococcal infection;
- 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;
- 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.
- 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;
- Have been diagnosed within the preceding 5 years with a malignant neoplastic disease, other than locally invasive cutaneous squamous or basal cell carcinoma;
- Have alveolar haemorrhage with hypoxia defined by an oxygen saturation \<85% or that requires the use of invasive or noninvasive ventilatory support;
- Have undergone dialysis within 7 days prior to Screening;
- Have undergone therapeutic plasma exchange within 7 days prior to the first dose of study drug; or
- Have known hypersensitivity to the study drug or any of the excipients used in the formulation of the study drug.
Trial locations and contacts
53 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
53 sites in 10 countries
France11 sites, 10 recruiting
- Recruiting
CHU Bordeaux - Hopital Pellegrin
Bordeaux, 33000
- Recruiting
Centre Hospitalier Boulogne sur Mer
Boulogne-sur-Mer, Cedex, 62200
- Recruiting
CHRU de Brest - Hopital de la Cavale Blanche
Brest, 29200
- Recruiting
CHU Grenoble-Alpes - Hopital Michallon
La Tronche, 38700
- Active, not recruiting
AP-HM - Hopital de La Conception
Marseille, 13385
- Recruiting
CHU de Nantes - Hotel-Dieu
Nantes, 44000
- Recruiting
CHU de Nimes
Nîmes, 31000
- Recruiting
AP-HP Hopital Pitie-Salpetriere
Paris, 75013
- Recruiting
AP-HP Hopital Cochin
Paris, 75014
- Recruiting
CHU de Toulouse - Hopital Rangueil
Toulouse, 31400
- Recruiting
Centre Hospitalier de Valenciennes
Valenciennes, 59300
Germany8 sites, 8 recruiting
- Recruiting
Charite Universitaetsmedizin Berlin
Berlin, 10117
- Recruiting
Universitaetsklinikum Koeln (AoeR)
Cologne, 50931
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
- Recruiting
Universitaetsklinikum Essen
Essen, 45147
- Recruiting
Medizinische Hochschule Hannover (MHH)
Hanover, 30625
- Recruiting
Universitaetsklinikum Leipzig
Leipzig, 04103
- Recruiting
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, 23562
- Recruiting
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, 80802
United Kingdom7 sites, 7 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B152GW
- Recruiting
Cambridge University - Addenbrooke's Hospital
Cambridge, CB2 0QQ
- Recruiting
Royal Liverpool University Hospital
Liverpool, L78YE
- Recruiting
Imperial College Healthcare NHS Trust
London, W21NY
- Recruiting
Royal Free London NHS Foundation Trust
London
- Recruiting
Manchester University NHS Foundation Trust (MFT)
Manchester
- Recruiting
Royal Preston Hospital
Preston, PR2 9HT
Denmark5 sites, 4 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
- Recruiting
Aarhus University Hospital
Aarhus, 8200
- Recruiting
Rigshospitalet
Copenhagen, 56 2100
- Active, not recruiting
Herlev Hospital
Herlev, 2730
- Recruiting
Odense University Hospital
Odense, 5000
Italy5 sites, 5 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
- Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, 00168
- Recruiting
APSS Ospedale Santa Chiara di Trento
Trento, 38122
Spain5 sites, 5 recruiting
- Recruiting
Fundacio Puigvert
Barcelona, 08025
- Recruiting
Hospital Universitari de Bellvitge
Barcelona, 08907
- Recruiting
Hospital Universitari Arnau de Vilanova
Lleida, 25198
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 29001
Switzerland4 sites, 3 recruiting
- Recruiting
Kantonsspital Baden AG
Baden, 5404
- Recruiting
Inselspital, Universitaetsspital Bern
Bern, 3010
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, 9000
- Withdrawn
Hôpital Fribourgeois-Freiburger Spital
Villars-sur-Glâne, 1752
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Keçiören
- Recruiting
Marmara University Medical Faculty Hospital
Istanbul
- Recruiting
Kocaeli University Medical School - Internal Medicine - Nephrology
Kocaeli
- Recruiting
Erciyes University Faculty of Medicine
Melikgazi
Czechia2 sites, 2 recruiting
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
- Recruiting
Institut klinicke a experimentalni mediciny
Prague, 140 21
Sweden2 sites, 2 recruiting
- Recruiting
Linkoping University Hospital
Linköping, 581 85
- Recruiting
University Hospital of Umea
Umeå, 907 37
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Intravenously Administered ALE.F02 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Renal Sparing in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis With Rapidly Progressive Glomerulonephritis
The goal of this clinical trial is to learn if a new drug that might help protect and preserve kidney function in antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV). AAV is a type of autoimmune disease where the body's own immune system attacks itself, and in the case of AAV the body attacks its own small blood vessels. There are many small blood vessels in the kidneys meaning the kidneys are commonly affected in AAV.
The main questions it aims to answer are:
Read more
- Is the new drug well tolerated and safe?
- Can the new drug protect and preserve kidney functions when is added to standard therapy?
Researchers will compare the following groups to see how the new drug is tolerated and what effect to preserve kidney tissue has:
- Group A: Standard treatment + ALE.F02 low dose infusions
- Group B: Standard treatment + ALE.F02 high dose infusions
- Group C: Standard treatment + ALE.F02 maximum dose infusions
- Group D: Standard treatment + placebo infusions (inactive substance)
The Treatment period will consist of 24 weeks beginning on Day 1, during which time participants will receive 13 infusions of the study medicine, along with standard therapy for kidney inflammation due to AAV. During the treatment period, participants will have the following assessments:
- A brief physical examination focusing on their skin any pre-existing medical conditions that you have.
- Collection of blood and urine samples for routine safety tests and to assess renal function.
- Collection of blood samples:
- To measure the amount of study medicine in their blood. This is called pharmacokinetics (PK) and it is tested to see how study medicine enters, moves through, and exits the body.
- To test for antidrug antibodies (ADA). To check if their body create antibodies against the study medicine, as this could reduce its effect.
- To measure biomarkers. Biomarkers are specific compounds in the body (can be protein, hormones, or genetic molecules) that indicate normal or abnormal processes taking place in your body and may be a sign of an underlying condition or disease (for example glucose levels are used as biomarker in managing diabetes). They are used to see how well the body responds to a treatment for a disease or condition.
- Collection of urine to measure urine markers of vasculitis/inflammation called biomarkers.
- Urine pregnancy test. A urine pregnancy test is a quick medical test that can tell if a woman is pregnant or not by checking for a hormone which is produced during pregnancy, usually in the urine.
- Chest High Resolution Computed Tomography (HRCT) scan to check whether they have vasculitis affecting their lungs. A CT scan uses special x-ray equipment to take detailed pictures of body tissues and organs to diagnose and monitor conditions in various parts of the body. For the CT scan, they will need to lie still on a table. At Week 24 a second lung CT scan will be performed for participants whose initial scan showed lung vasculitis to see whether your lung vasculitis is getting better or ongoing/worse.
- Conditions
- Glomerulonephritis Rapidly Progressive
- Being tested
- ALE.F02, Rituximab, GlucoCorticoid, Cyclophosphamid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALE.F02Biological
ALE.F02 is an anti-Claudin-1 (CLDN1) monoclonal antibody (mAb) to selectively target the non-tight junctions (TJ), exposed form of CLDN1. CLDN1 is an integral component of the TJs between cells.
RituximabDrug
Rituximab is a monoclonal antibody that targets cluster of differentiation antigen 20 (CD20), an antigen expressed on the surface of pre-B and mature B-lymphocytes
GlucoCorticoidDrug
Glucocorticoids are a class of corticosteroids, which are a class of steroid hormones that bind to the glucocorticoid receptor. Glucocorticoid effects may be broadly classified into two major categories: immunological and metabolic.
CyclophosphamidDrug
Cyclophosphamid is a medication used as chemotherapy and to suppress the immune system
PlaceboDrug
Drug product that will contain no active ingredient
Immunosuppressive AgentsDrug
Immunosuppressants are drugs that prevent your immune system from attacking healthy cells and tissues by mistake.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment + ALE.F02 low dose infusions | Experimental | Standard treatment + ALE.F02 low dose infusions Receives: Biological: ALE.F02; Drug: Rituximab; Drug: GlucoCorticoid; Drug: Cyclophosphamid; Drug: Immunosuppressive Agents |
| Standard treatment + ALE.F02 high dose infusions | Experimental | Standard treatment + ALE.F02 high dose infusions Receives: Biological: ALE.F02; Drug: Rituximab; Drug: GlucoCorticoid; Drug: Cyclophosphamid; Drug: Immunosuppressive Agents |
| Standard treatment + placebo infusions (inactive substance) | Placebo comparator | Standard treatment + placebo infusions (inactive substance) Receives: Drug: Rituximab; Drug: GlucoCorticoid; Drug: Cyclophosphamid; Drug: Placebo; Drug: Immunosuppressive Agents |
| Standard treatment + ALE.F02 maximum dose infusions | Experimental | Standard treatment + ALE.F02 maximum dose infusions Receives: Biological: ALE.F02; Drug: Rituximab; Drug: GlucoCorticoid; Drug: Cyclophosphamid; Drug: Immunosuppressive Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for this study is the safety and tolerability of ALE.F02 when administered as a continuous IV infusion in patients with rapidly progressive glomerulonephritis (RPGN) attributed to AAV.
Safety endpoints are the following:
- All adverse events (AEs);
- All serious adverse events (SAEs);
- Hematology and clinical chemistry analyte assessments;
- Serum lipids;
- Antidrug antibodies (ADAs); and
- ECGs
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
The key secondary endpoint for this study is the change in mean estimated glomerular filtration rate (eGFR) from baseline to Week 24/End of Treatment (EOT) for recipients of ALE.F02 compared to placebo.
Measured: from baseline to Week 24/EOT
Change in mean urine protein to creatinine ratio (UPCR) area under the concentration time curve (AUC) from baseline to Week 24/EOT for recipients of ALE.F02 compared to placebo;
Measured: from baseline to Week 24/EOT
Change in mean urine protein to creatinine ratio (UPCR) area under the concentration time curve (AUC) from baseline to Week 52/End of Study (EOS) for recipients of ALE.F02 compared to placebo;
Measured: from baseline to Week 52/EOS
Time to stable proteinuria (≤0.5 g/day for ≥14 days) during the Treatment Period for recipients of ALE.F02 compared to placebo;
Measured: up to 24 weeks
Time to stable hematuria (≤5 RBCs/high-power field for ≥14 days) during the Treatment Period for recipients of ALE.F02 compared to placebo;
Measured: up to 24 weeks
Incidence of renal replacement therapy (RRT) at any time during the study for recipients of ALE.F02 compared to placebo; and
Measured: through study completion, an average of 1 year
Total glucocorticoid and immunosuppressive exposure at Week 24/EOT and Week 52/EOS for recipients of ALE.F02 compared to placebo.
Measured: at Week 24/EOT and Week 52/EOS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start7 Sep 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis Rapidly ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alentis Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047171
- Sponsor's protocol ID
- ALE.F02.03
- Other IDs
- 2022-502184-38, U1111-1286-9095
- Acronym
- RENAL-F02
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Intravenously Administered ALE.F02 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Renal Sparing in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis With Rapidly Progressive Glomerulonephritis
- ClinicalTrials.gov ID
- NCT06047171
- Acronym / sponsor ID
- RENAL-F02 / ALE.F02.03
- Conditions
- Glomerulonephritis Rapidly Progressive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alentis Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a new drug that might help protect and preserve kidney function in antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV). AAV is a type of autoimmune disease where the body's own immune system attacks itself, and in the case of AAV the body attacks its own small blood vessels. There are many small blood vessels in the kidneys meaning the kidneys are commonly affected in AAV.
The main questions it aims to answer are:
- Is the new drug well tolerated and safe?
- Can the new drug protect and preserve kidney functions when is added to standard therapy?
Researchers will compare the following groups to see how the new drug is tolerated and what effect to preserve kidney tissue has:
- Group A: Standard treatment + ALE.F02 low dose infusions
- Group B: Standard treatment + ALE.F02 high dose infusions
- Group C: Standard treatment + ALE.F02 maximum dose infusions
- Group D: Standard treatment + placebo infusions (inactive substance)
The Treatment period will consist of 24 weeks beginning on Day 1, during which time participants will receive 13 infusions of the study medicine, along with standard therapy for kidney inflammation due to AAV. During the treatment period, participants will have the following assessments:
- A brief physical examination focusing on their skin any pre-existing medical conditions that you have.
- Collection of blood and urine samples for routine safety tests and to assess renal function.
- Collection of blood samples:
- To measure the amount of study medicine in their blood. This is called pharmacokinetics (PK) and it is tested to see how study medicine enters, moves through, and exits the body.
- To test for antidrug antibodies (ADA). To check if their body create antibodies against the study medicine, as this could reduce its effect.
- To measure biomarkers. Biomarkers are specific compounds in the body (can be protein, hormones, or genetic molecules) that indicate normal or abnormal processes taking place in your body and may be a sign of an underlying condition or disease (for example glucose levels are used as biomarker in managing diabetes). They are used to see how well the body responds to a treatment for a disease or condition.
- Collection of urine to measure urine markers of vasculitis/inflammation called biomarkers.
- Urine pregnancy test. A urine pregnancy test is a quick medical test that can tell if a woman is pregnant or not by checking for a hormone which is produced during pregnancy, usually in the urine.
- Chest High Resolution Computed Tomography (HRCT) scan to check whether they have vasculitis affecting their lungs. A CT scan uses special x-ray equipment to take detailed pictures of body tissues and organs to diagnose and monitor conditions in various parts of the body. For the CT scan, they will need to lie still on a table. At Week 24 a second lung CT scan will be performed for participants whose initial scan showed lung vasculitis to see whether your lung vasculitis is getting better or ongoing/worse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard treatment + ALE.F02 low dose infusions | Experimental | Biological: ALE.F02, Drug: Rituximab, Drug: GlucoCorticoid, Drug: Cyclophosphamid, Drug: Immunosuppressive AgentsStandard treatment + ALE.F02 low dose infusions |
| Standard treatment + ALE.F02 high dose infusions | Experimental | Biological: ALE.F02, Drug: Rituximab, Drug: GlucoCorticoid, Drug: Cyclophosphamid, Drug: Immunosuppressive AgentsStandard treatment + ALE.F02 high dose infusions |
| Standard treatment + placebo infusions (inactive substance) | Placebo comparator | Drug: Rituximab, Drug: GlucoCorticoid, Drug: Cyclophosphamid, Drug: Placebo, Drug: Immunosuppressive AgentsStandard treatment + placebo infusions (inactive substance) |
| Standard treatment + ALE.F02 maximum dose infusions | Experimental | Biological: ALE.F02, Drug: Rituximab, Drug: GlucoCorticoid, Drug: Cyclophosphamid, Drug: Immunosuppressive AgentsStandard treatment + ALE.F02 maximum dose infusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Must be willing and able to comply with the study requirements and give informed consent for participation in the study;
- 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;
- 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.
- 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);
Key exclusion criteria (24 listed)
- Have a history of previous RPGN that resolved or ameliorated (ie, the patient had a documented case of RPGN and has suffered a relapse);
- Have a positive serology test for anti-glomerular basement membrane antibodies;
- 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;
- Have a chronic infection that could be exacerbated by RPGN or SOC therapy for RPGN;
- Have active hepatitis B, hepatitis C, or HIV infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALE.F02ALE.F02 is an anti-Claudin-1 (CLDN1) monoclonal antibody (mAb) to selectively target the non-tight junctions (TJ), exposed form of CLDN1. CLDN1 is an integral component of the TJs between cells. | Biological | Standard treatment + ALE.F02 high dose infusions, Standard treatment + ALE.F02 low dose infusions, Standard treatment + ALE.F02 maximum dose infusions |
| RituximabRituximab is a monoclonal antibody that targets cluster of differentiation antigen 20 (CD20), an antigen expressed on the surface of pre-B and mature B-lymphocytes | Drug | Standard treatment + ALE.F02 high dose infusions, Standard treatment + ALE.F02 low dose infusions, Standard treatment + ALE.F02 maximum dose infusions, Standard treatment + placebo infusions (inactive substance) |
| GlucoCorticoidGlucocorticoids are a class of corticosteroids, which are a class of steroid hormones that bind to the glucocorticoid receptor. Glucocorticoid effects may be broadly classified into two major categories: immunological and metabolic. | Drug | Standard treatment + ALE.F02 high dose infusions, Standard treatment + ALE.F02 low dose infusions, Standard treatment + ALE.F02 maximum dose infusions, Standard treatment + placebo infusions (inactive substance) |
| CyclophosphamidCyclophosphamid is a medication used as chemotherapy and to suppress the immune system | Drug | Standard treatment + ALE.F02 high dose infusions, Standard treatment + ALE.F02 low dose infusions, Standard treatment + ALE.F02 maximum dose infusions, Standard treatment + placebo infusions (inactive substance) |
| PlaceboDrug product that will contain no active ingredient | Drug | Standard treatment + placebo infusions (inactive substance) |
| Immunosuppressive AgentsImmunosuppressants are drugs that prevent your immune system from attacking healthy cells and tissues by mistake. | Drug | Standard treatment + ALE.F02 high dose infusions, Standard treatment + ALE.F02 low dose infusions, Standard treatment + ALE.F02 maximum dose infusions, Standard treatment + placebo infusions (inactive substance) |
Primary outcome
The primary endpoint for this study is the safety and tolerability of ALE.F02 when administered as a continuous IV infusion in patients with rapidly progressive glomerulonephritis (RPGN) attributed to AAV.
Time frame: through study completion, an average of 1 year
Safety endpoints are the following: * All adverse events (AEs); * All serious adverse events (SAEs); * Hematology and clinical chemistry analyte assessments; * Serum lipids; * Antidrug antibodies (ADAs); and * ECGs
7 secondary outcomes
The key secondary endpoint for this study is the change in mean estimated glomerular filtration rate (eGFR) from baseline to Week 24/End of Treatment (EOT) for recipients of ALE.F02 compared to placebo.
Time frame: from baseline to Week 24/EOT
Change in mean urine protein to creatinine ratio (UPCR) area under the concentration time curve (AUC) from baseline to Week 24/EOT for recipients of ALE.F02 compared to placebo;
Time frame: from baseline to Week 24/EOT
Change in mean urine protein to creatinine ratio (UPCR) area under the concentration time curve (AUC) from baseline to Week 52/End of Study (EOS) for recipients of ALE.F02 compared to placebo;
Time frame: from baseline to Week 52/EOS
Time to stable proteinuria (≤0.5 g/day for ≥14 days) during the Treatment Period for recipients of ALE.F02 compared to placebo;
Time frame: up to 24 weeks
Time to stable hematuria (≤5 RBCs/high-power field for ≥14 days) during the Treatment Period for recipients of ALE.F02 compared to placebo;
Time frame: up to 24 weeks
Incidence of renal replacement therapy (RRT) at any time during the study for recipients of ALE.F02 compared to placebo; and
Time frame: through study completion, an average of 1 year
Total glucocorticoid and immunosuppressive exposure at Week 24/EOT and Week 52/EOS for recipients of ALE.F02 compared to placebo.
Time frame: at Week 24/EOT and Week 52/EOS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
53 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALE.F02, Rituximab and GlucoCorticoid in people with Glomerulonephritis Rapidly Progressive, run by Alentis Therapeutics AG at 53 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France, Germany, United Kingdom, Denmark, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Benabed (+41 78 266 19 91, mohamed.benabed@alentis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint for this study is the safety and tolerability of ALE.F02 when administered as a continuous IV infusion in patients with rapidly progressive glomerulonephritis (RPGN) attributed to AAV. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.