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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Ixekizumab Diabetes Intervention Trial (I-DIT)

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

Ixekizumab Diabetes Intervention Trial (I-DIT) (NCT04589325) is a Phase 2 interventional studying Type1 Diabetes Mellitus, sponsored by Göteborg University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Type1 Diabetes Mellitus and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 127 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Type1 Diabetes Mellitus subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed willing to sign a consent form and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations before trial activities are begun. - Must be willing and capable of taking the study drugs and meet for tests and follow up as described. - Diagnosed Type 1 Diabetes (E10.9) within 100 days. - First injection of insulin maximum 100 days prior to screening - Aged 18-45 years old. - Presence of antibodies at clinical practice or at screening to at least one of the following antigens: insulin/IAA, GAD-65, IA-2 and ZnT8. - Remaining stimulated peak C-peptide ≥ 0.20 nmol/L. If age 36-45 years, peak C-peptide should be \<2.0 nmol/L. - Male subjects agree to use a reliable method of birth control during the study - Female subjects: Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counseled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug or remain abstinent during the study and for at least 12 weeks following the last dose of study drug. If the highly effective contraceptive methods are contraindicated or strictly declined by patient, acceptable birth control methods may be considered. These may include combination of both of the following methods: - Male or female condom with spermicide - Cap, diaphragm, or sponge with spermicide 1. Highly effective methods of contraception (use 1 form): 1. combined oral contraceptive pill and mini-pill 2. NuvaRing® 3. implantable contraceptives 4. injectable contraceptives (such as Depo-Provera®) 5. intrauterine device (such as Mirena® and ParaGard®) 6. contraceptive patch-ONLY women \<198 pounds or 90 kg 7. abstinence from sex ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
INCLUSION CRITERIA: * Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations before trial activities are begun. * Must be willing and capable of taking the study drugs and meet for tests and follow up as described. * Diagnosed Type 1 Diabetes (E10.9) within 100 days. * First injection of insulin maximum 100 days prior to screening * Aged 18-45 years old. * Presence of antibodies at clinical practice or at screening to at least one of the following antigens: insulin/IAA, GAD-65, IA-2 and ZnT8. * Remaining stimulated peak C-peptide ≥ 0.20 nmol/L. If age 36-45 years, peak C-peptide should be \<2.0 nmol/L. * Male subjects agree to use a reliable method of birth control during the study * Female subjects: Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counseled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug or remain abstinent during the study and for at least 12 weeks following the last dose of study drug. If the highly effective contraceptive methods are contraindicated or strictly declined by patient, acceptable birth control methods may be considered. These may include combination of both of the following methods: * Male or female condom with spermicide * Cap, diaphragm, or sponge with spermicide 1. Highly effective methods of contraception (use 1 form): 1. combined oral contraceptive pill and mini-pill 2. NuvaRing® 3. implantable contraceptives 4. injectable contraceptives (such as Depo-Provera®) 5. intrauterine device (such as Mirena® and ParaGard®) 6. contraceptive patch-ONLY women \<198 pounds or 90 kg 7. abstinence from sex 8. vasectomy-for men in clinical studies 2. Effective methods of contraception (use 2 forms combined) * male condom with spermicide * female condom with spermicide * diaphragm with spermicide * cervical sponge * cervical cap with spermicide Females who are not of childbearing potential include those who have undergone or who have: * female sterilization * hysterectomy * menopause * Müllerian agenesis (Mayer-Rokitansky-Küster-Hauser syndrome \[also referred to as congenital absence of the uterus and vagina\]) EXCLUSION CRITERIA: * Contraindications to Ixekizumab. * Treatment with any oral or injected glucose-lowering agents other than insulin. * A history of haemolytic anaemia or significantly abnormal haematology/coagulation results at screening. * Participation in other clinical trials with a new chemical entity within the previous 3 months. * Subjects with severe obesity (BMI \>35 kg/m2 if age 18-35 years and BMI \>30 kg/m2 if age 36-45). * Subjects with other autoimmune disease, e.g. Mb Crohn, Ulcerative colitis, Graves disease, psoriasis, psoriasis arthritis and axial spondylarthrosis, except celiac disease and hypothyroidism which do not need to be excluded for. * Active serious or chronic infections (ie: in case patient had a serious infection (eg pneumonia, cellulitis), has been hospitalized, has received intravenous antibiotics for an infection within 12 weeks prior to screening visit, had a serious bone or joint infection within 24 weeks before screening visit, has ever had an infection of an artificial joint * Known immunodeficiency or patient is immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient * Tuberculosis * History of HIV, hepatitis B or C * Active or recurrent fungal infection * Subjects with myocardial infarction, stroke, unstable angina or heart failure last 6 months * Current clinically significant cardiac arrhythmias as verified by ECG * Planned surgery during the treatment period of the study (except minor surgery on skin lesions, e.g., nevus) * For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after discontinuation. * For male subjects: intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness of their partner to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. * Any history of malignancy the last 5 years except for completely resected squamous or basal cell carcinoma of the skin. * Administration of live attenuated vaccine(s) (LAV) within 2 months of enrolment. Or intended use of LAV during the treatment period. * The investigator judges that the clinical diagnosis of T1D set is incorrect or uncertain (needs to be confirmed by discussion with experienced diabetologist if excluding due to this criterion) * Allergy against ingredients of the investigational products. * Known allergy or hypersensitivity to any biologic therapy (active substance or excipients) that would pose an unacceptable risk to the patient if participating in the study * Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study. * Liver injury criteria: patients with active hepatobiliary diseases or at screening having alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal (\>2.5 x ULN) * Laboratory abnormalities at screening: 1. Neutrophil count \< 1,500 cells/ μL (=1,5 \*109 cells/ L) 2. Platelet count \< 100,000 cells/ μL (= 100 \*109 cells/ L) 3. Hemoglobin \< 8.5 g/dL (= \<85 g/L) (males) and \<8g/dL (= \<80 g/L) (women)

Treatments Being Tested

DRUG

Ixekizumab

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.

DRUG

Placebo

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04589325), the sponsor (Göteborg University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04589325 clinical trial studying?

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 wi… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04589325?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04589325?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04589325. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04589325. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.