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Study on Ixekizumab for Preserving Insulin Production in Newly Diagnosed Type 1 Diabetes Patients

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What is this trial about?

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

This clinical trial is focused on studying Type 1 Diabetes, a condition where the body’s immune system attacks the cells in the pancreas that produce insulin. The study is testing a treatment called Ixekizumab, which is a solution for injection. The purpose of the study is to see if Ixekizumab can help preserve the body's ability to produce insulin in people who have been recently diagnosed with Type 1 Diabetes. Participants in the study will receive either Ixekizumab or a placebo, which looks like the treatment but does not contain the active substance.

The study will last for about a year, during which participants will receive regular injections and attend follow-up visits. Throughout the study, the researchers will monitor how well the body continues to produce insulin by measuring a substance called C-peptide, which is linked to insulin production. This will help determine if Ixekizumab is effective in maintaining insulin production in the body. Participants will also have their insulin dosage and blood sugar levels monitored to see how these change over the course of the study.

By the end of the study, the researchers aim to understand whether Ixekizumab can help people with newly diagnosed Type 1 Diabetes maintain their natural insulin production. This could potentially lead to better management of the disease and improve the quality of life for those affected. The study is expected to conclude by the end of 2028.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, the first step involves an initial visit where the patient will review and sign an informed consent form. This document ensures that the patient understands the study's purpose, procedures, and potential risks.

    The patient must agree to cooperate with the treatment plan and follow-up visits as outlined in the study protocol.

  2. Step 2

    Eligibility confirmation

    The patient will undergo a series of tests to confirm eligibility for the study. This includes verifying a diagnosis of type 1 diabetes within the last 100 days and checking for specific antibodies.

    The patient must be between 18 and 45 years old and meet other health criteria, such as a specific level of C-peptide, which is a marker of insulin production.

  3. Step 3

    Randomization and treatment assignment

    Once eligibility is confirmed, the patient will be randomly assigned to receive either the study medication, Ixekizumab, or a placebo. The placebo looks like the study medication but does not contain the active ingredient.

    The medication is administered as a subcutaneous injection, which means it is injected under the skin.

  4. Step 4

    Treatment phase

    The patient will receive the assigned treatment over a period of 52 weeks. The specific dosage and frequency of the injections will be explained by the study team.

    Regular follow-up visits will be scheduled to monitor the patient's health and response to the treatment. These visits may include blood tests and other assessments.

  5. Step 5

    Monitoring and assessments

    Throughout the study, the patient's insulin production will be measured using a test called the Mixed Meal Tolerance Test (MMTT). This test helps assess how well the body is producing insulin.

    Additional monitoring will include tracking blood sugar levels, insulin dosage, and other health indicators using devices like the Continuous Glucose Monitor (CGM).

  6. Step 6

    End of study evaluation

    At the end of the 52-week treatment period, the patient will undergo a final evaluation to assess the effects of the treatment.

    The study team will review all collected data to determine the impact of Ixekizumab on insulin production and overall health.

Who can join the trial?

9 criteria

  • Must provide signed informed consent, which means you agree to participate in the study and follow the study rules.
  • Must be willing and able to take the study drugs and attend tests and follow-up appointments as required.
  • Must have been diagnosed with Type 1 Diabetes within the last 100 days.
  • Must have received the first insulin injection no more than 100 days before the screening. If you are aged 36-45 years, you should be using both basal (long-acting) and prandial (mealtime) insulin, or using an insulin pump.
  • Must be between 18 and 45 years old.
  • Must have antibodies present in your blood to at least one of the following: insulin/IAA, GAD-65, IA-2, or ZnT8. Antibodies are proteins made by your immune system.
  • Must have a remaining stimulated peak C-peptide level of at least 0.20 nmol/L. If you are aged 36-45 years, your peak C-peptide should be less than 2.0 nmol/L. C-peptide is a substance made in the pancreas, and its level helps to measure insulin production.
  • Male participants must agree to use a reliable method of birth control during the study.
  • Female participants who can become pregnant must test negative for pregnancy and agree to use one highly effective method of contraception or two acceptable methods combined during the study and for at least 12 weeks after the last dose of the study drug. Alternatively, they can choose to remain abstinent during this period.

Who cannot join the trial?

3 criteria

  • Patients who do not have Type 1 Diabetes cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fit the required age group.
  • Patients who are part of a vulnerable population cannot participate. This generally means groups that might need special protection or care.
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Investigated drugs

Ixekizumab is a medication used in this clinical trial to help preserve the body's ability to produce insulin in people who have recently been diagnosed with type 1 diabetes. It works by targeting specific parts of the immune system that may be involved in the destruction of insulin-producing cells in the pancreas. The goal of using Ixekizumab in this study is to see if it can help maintain the body's natural insulin production, which is important for managing blood sugar levels in people with type 1 diabetes.

What is already known about the treatment

Ixekizumab – Ixekizumab is administered as an injection under the skin, typically in the form of a pre-filled syringe or auto-injector. It is currently being studied in clinical trials for its potential use in treating type 1 diabetes, a condition where the body's immune system attacks insulin-producing cells. The main goal of using Ixekizumab in this context is to help preserve the body's natural insulin production in newly diagnosed patients. At the molecular level, Ixekizumab works by targeting and neutralizing a specific protein in the immune system called interleukin-17A, which plays a role in inflammation. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Type 1 Diabetes – Type 1 Diabetes is an autoimmune condition where the immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. This leads to little or no insulin production, a hormone essential for allowing glucose to enter cells for energy. As a result, blood glucose levels become elevated. The disease often begins in childhood or young adulthood and progresses with the complete loss of insulin production over time. Individuals with Type 1 Diabetes require lifelong management to maintain blood sugar levels within a normal range. The progression involves fluctuations in blood sugar levels, which can lead to various complications if not managed properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508588-58-00Estimated enrolment127 patientsSponsorNU Hospital Group-Vaestra Goetalandsregionen

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