Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study of the efficacy and safety of ladarixin and rabbit anti-human thymocyte immunoglobulin in adolescents and adults with new-onset type 1 diabetes

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals diagnosed with new-onset Type 1 Diabetes, an autoimmune condition where the body's immune system attacks the cells in the pancreas that produce insulin. The research aims to evaluate the effectiveness and safety of combining two different treatments. One treatment is Ladarixin, which is an oral medication taken in capsule form. The other is Antithymocyte Globulin, which is administered through an infusion, a process where medication is delivered directly into a vein.

Participants in the study will be assigned to different groups to receive either the combination of both medications or Antithymocyte Globulin along with a placebo. During the course of the study, changes in the body's ability to produce insulin will be monitored. This is measured by looking at levels of C-peptide, a substance produced by the body when insulin is made, often following a Mixed Meal Tolerance Test, which is a procedure used to see how the body reacts to consuming a meal.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    A single low dose of rabbit anti-human thymocyte immunoglobulin, also known as antithymocyte globulin, is administered via infusion. infusion is a method where liquid medication is delivered directly into a vein.

    At the same time, a medication called ladarixin is taken orally in the form of an 800 mg hard capsule. in some cases, a placebo, which contains no active medicine, is provided instead of ladarixin.

  2. Step 2

    Monitoring and assessments

    Throughout the study, various measurements are taken to monitor health. these include checking fasting and stimulated C-peptide levels, which help measure how much insulin the body produces, and HbA1c, which shows average blood sugar levels over time.

    Daily insulin requirements and blood sugar patterns are recorded using a continuous glucose monitor (CGM). this device tracks blood sugar levels constantly to see the time in range, time in tight range, and time below range.

    Questionnaires are completed to evaluate quality of life, treatment satisfaction, and the fear of hypoglycemia, which is the fear of blood sugar dropping too low.

  3. Step 3

    Twelve month evaluation

    At the 12 month mark, a mixed meal tolerance test (MMTT) is performed. during this test, blood is checked over a 2 hour period after eating a meal to measure the stimulated C-peptide response, which shows how the body reacts to food by producing insulin.

Who can join the trial?

12 criteria

  • Participants must be able to provide informed consent, which means giving permission to join the study after understanding all the details. For teenagers aged 14 to 17, they must provide assent (their own agreement) and a parent or guardian must provide consent.
  • The person must have been diagnosed with Type 1 Diabetes (a condition where the body cannot make insulin) based on specific medical guidelines.
  • The diagnosis of Type 1 Diabetes must have occurred less than 180 days before joining the study.
  • The person must currently use, or have used in the past, exogenous insulin, which is insulin that is injected into the body from an outside source.
  • The person must test positive for at least one diabetes-related autoantibody. An autoantibody is a protein produced by the immune system that mistakenly attacks the body's own healthy cells.
  • Participants must be willing to follow intensive diabetes management, which refers to the standard daily routine of monitoring blood sugar and managing the condition.
  • Participants must have received their last live immunization (a vaccine that uses a weakened form of a germ) at least 6 weeks before the study starts and must agree not to receive any live vaccines for 6 months after the treatment ends.
  • If the diagnosis was made less than 100 days ago, the person must have a fasting C-peptide level greater than 0.2 ng/mL. C-peptide is a substance produced by the body when it makes insulin, used to measure how much insulin the body is still producing naturally.
  • If the diagnosis was made 100 days ago or more, the person must have a stimulated C-peptide level of at least 0.6 ng/ml during a glucagon test (a test that uses a hormone to trigger insulin production).
  • At the start of the Mixed Meal Tolerance Test (a test where you eat a specific meal to see how your body reacts), the C-peptide level must be at least 0.2 ng/ml.
  • The person's BMI (Body Mass Index, a measure of body fat based on height and weight) must be less than 30.
  • The person's HbA1c (a blood test that shows the average blood sugar levels over the past 2 to 3 months) must be less than 10%.

Who cannot join the trial?

17 criteria

  • Being pregnant, breastfeeding, or planning to become pregnant during the study.
  • Being unable or unwilling to use effective birth control (methods used to prevent pregnancy) if you are sexually active.
  • Having a past or current infection caused by tuberculosis or other similar bacteria.
  • Having a weakened immune system (the body's defense against germs) or low levels of certain blood cells, such as white blood cells (which fight infection), neutrophils (a specific type of white blood cell), lymphocytes (cells that help fight germs), or platelets (cells that help blood clot).
  • Needing to take medications that suppress or change how the immune system works, including long-term use of steroids (medicines that reduce inflammation).
  • Having kidney problems, specifically if a waste product called creatinine is higher than the normal limit for your age.
  • Having liver problems, specifically if certain liver enzymes called AST or ALT are much higher than the normal limit.
  • Having a significant blood clotting disorder (a condition where blood does not clot properly).
  • Having any active chronic infections (long-lasting infections) or acute infections (sudden, short-term infections) that would make it unsafe to use medicines that lower immune system activity.
  • Having other health issues that could make the study difficult or risky, such as heart disease, COPD (a lung disease that makes breathing difficult), sickle cell disease (a blood disorder), neurological issues (problems with the brain or nerves), or abnormal blood counts.
  • Having a history of malignancies (cancer), except for treated skin cancer.
  • Using any medications other than insulin that affect blood sugar levels within 7 days before the study begins.
  • Participating in another clinical trial for Type 1 Diabetes treatment within the last 30 days.
  • Having previously received treatment with ATG, Abatacept, or anti-CD3 antibodies (specific types of immune-system medications).
  • Having a known allergy to ATG, rabbit proteins, or excipients (inactive ingredients in a medicine), or having a sensitivity to non-steroidal anti-inflammatory drugs (common pain relievers) or lactose intolerance (difficulty digesting milk sugar).
  • Having specific heart rhythm problems, such as a QTcF (a measurement of the heart's electrical cycle) greater than 470 msec, Complete Left Bundle Branch Block (an electrical conduction issue in the heart), or certain types of heart blocks (interruptions in the heart's electrical signals).
  • Having any psychological or psychiatric conditions (mental health conditions) that could interfere with following the study rules or receiving the treatment.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Rabbit anti-human thymocyte immunoglobulin

    is an infusion therapy used in this study to help manage the immune system in people with newly diagnosed type 1 diabetes.

  • Ladarixin

    is a medication taken by mouth in capsule form that is being tested to see how it works alongside the infusion therapy to help manage the condition.

What is already known about the treatment

  • Rabbit anti-human thymocyte immunoglobulin

    This medication is administered through an intravenous infusion to help regulate the immune system. It is an established treatment used to prevent or treat organ transplant rejection and certain autoimmune conditions. The substance works by attaching to and neutralizing specific immune cells, such as T-cells, which prevents them from attacking the body's own healthy tissues. It is classified as an immunosuppressant.

  • Ladarixin

    This medication is taken orally in the form of a hard capsule. It is currently being studied in clinical trials to see if it can help protect the body's insulin-producing cells in people newly diagnosed with type 1 diabetes. The drug is believed to work by reducing inflammation and protecting cells from damage caused by the immune system. It is classified as an experimental therapeutic agent.

Investigated diseases

Type 1 diabetes - This is a condition where the body's immune system mistakenly attacks the cells in the pancreas that produce insulin. As the disease progresses, these specific cells are destroyed, leading to a significant decrease in insulin production. Without enough insulin, the body cannot properly regulate blood sugar levels. The condition typically develops when the immune system fails to recognize these cells as part of the body. This disruption in the immune response is the primary driver of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524298-18-00Protocol codeATGLDX1-2025Estimated enrolment46 patientsSponsorOspedale San Raffaele S.r.l.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.