Rescue of Nephrons With ALE.F02 (RENAL-F02)

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). 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.

Conditions

• Glomerulonephritis Rapidly Progressive

Interventions

BIOLOGICAL

ALE.F02

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.

DRUG

Rituximab

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

DRUG

GlucoCorticoid

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.

DRUG

Cyclophosphamid

Cyclophosphamid is a medication used as chemotherapy and to suppress the immune system

DRUG

Placebo

Drug product that will contain no active ingredient

DRUG

Immunosuppressive Agents

Immunosuppressants are drugs that prevent your immune system from attacking healthy cells and tissues by mistake.

Sponsors & Collaborators

• Alentis Therapeutics AG

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-07

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Czechia
• Denmark
• France
• Germany
• Italy
• Spain
• Sweden
• Switzerland
• Turkey (Türkiye)
• United Kingdom

Study Locations