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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Stockholm – SLSO	Stockholm	Sweden
Region Dalarna	Falun	Sweden
NU Hospital Group-Vaestra Goetalandsregionen	Trollhattan	Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen	Skovde	Sweden
Region Halland	Varberg	Sweden
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland	Norrkoping	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
CTC Clinical Trial Consultants AB	Uppsala	Sweden
Region Skane Kristianstad Central Hospital	Kristianstad	Sweden
Region Joenkoepings Laen	Jönköping	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Rjvnjq Vmjfdowoj	Karlstad	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.09.2022

Trial locations

Investigated drugs:

Ixekizumab

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.

Investigated diseases:

Type 1 diabetes mellitus

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 ID:

2023-508588-58-00

NCT ID:

NCT04589325

Trial Phase:

Therapeutic exploratory (Phase II)

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

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