RecruitingPhase 2NCT04589325

Ixekizumab Diabetes Intervention Trial (I-DIT)

The Effect of Anti-IL17 in New-onset Type 1 Diabetes: a Randomized, Double-blind, Placebo-controlled Trial


Sponsor

Göteborg University

Enrollment

127 participants

Start Date

Nov 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Although the clinical onset of type 1 diabetes (T1D) is acute, the progression of T1D occurs over many years often in a patchy manner with inflammation in certain lobes of the pancreas, leaving other lobes unaffected and long-lasting beta cells remain functional decades after diagnosis. Psoriasis share several aspects with T1D, e.g. the patchy inflammatory infiltrate consisting of tissue-resident memory (TRM) T cells, leaky blood vessels that facilitate leukocyte migration and the increased risk for systemic conditions. Moreover, interleukin (IL)-17 has shown to be increased in both persons with psoriasis and T1D. Activation of IL-17/IL-22 pathway is viewed to be both a hallmark of psoriasis and human T1D. Ixekizumab, an anti-IL17 biological agent, has shown marked therapeutic value in the treatment of subjects with psoriasis in several randomized trials and is currently an approved clinical therapy. Due to the many similarities in the current view of pathogenesis and manifestation of T1D and psoriasis it is possible that Ixekizumab can also influence the disease process of T1D.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called ixekizumab — normally used for skin and joint conditions — can protect the insulin-producing cells in people who have just been diagnosed with Type 1 diabetes. The idea is that early intervention with an immune-calming drug might slow or stop the immune system's attack on the pancreas. **You may be eligible if...** - You have been diagnosed with Type 1 diabetes within the last 100 days - You are between 18 and 45 years old - You still have some remaining insulin production (measured by a C-peptide test) - You have diabetes-related antibodies in your blood - You are able and willing to use reliable contraception during the study **You may NOT be eligible if...** - Your diabetes was diagnosed more than 100 days ago - You have no remaining insulin-producing capacity - You are pregnant or planning to become pregnant during the study - You have other significant health conditions that may interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIxekizumab

Ixekizumab will be available at a concentration of 80 mg solution for injection in pre-filled syringes. Ixekizumab will be administrated by the patient via subcutaneous (s.c.) injections for a total treatment period of 12 months. Two s.c. injections (160 mg) will be administrated at week 0, one dose (80 mg) at week 2, 4, 6, 8, 10 and 12 and continue with a maintenance dose (80 mg) every 4th week for a total treatment period of 12 months.

DRUGPlacebo

Placebo will be available at a concentration of 80 mg solution for injection in pre-filled syringes. Placebo will be administrated by the patient via subcutaneous (s.c.) injections for a total treatment period of 12 months. Two s.c. injections (160 mg) will be administrated at week 0, one dose (80 mg) at week 2, 4, 6, 8, 10 and 12 and continue with a maintenance dose (80 mg) every 4th week for a total treatment period of 12 months.


Locations(17)

Södra Älvsborg Hospital

Borås, Sweden

Falu Lasarett

Falun, Sweden

Sahlgrenska University Hospital, Sahlgrenska

Gothenburg, Sweden

Sahlgrenska University Hospital, Östra Hospital

Gothenburg, Sweden

Länssjukhuset Ryhov

Jönköping, Sweden

Karlstad lasarett

Karlstad, Sweden

Kristianstad Hospital

Kristianstad, Sweden

Linköping University Hospital

Linköping, Sweden

Lund University Hospital

Lund, Sweden

Vrinnevi Hospital

Norrköping, Sweden

Örebro University Hospital

Örebro, Sweden

Skaraborgs sjukhus

Skövde, Sweden

Centrum för Diabetes,

Stockholm, Sweden

Södersjukhuset Hospital

Stockholm, Sweden

NU-Hospital Group

Uddevalla, Sweden

Uppsala Academic Hospital

Uppsala, Sweden

Varbergs sjukhus

Varberg, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04589325


Related Trials