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Ixekizumab treatment for newly diagnosed Type 1 diabetes

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

Phase 2 Interventional Göteborg University · NCT04589325

This study is testing if the drug Ixekizumab can help people with newly diagnosed Type 1 diabetes produce more insulin and manage their blood sugar better while they continue their usual treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment127 (estimated)
Ages18 Years to 45 Years
SexAll
SponsorGöteborg University Academic / other
Drugs / interventionsIxekizumab
Locations17 sites (Borås and 16 other locations)
Trial IDNCT04589325 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Ixekizumab, an anti-IL17 biological agent, on endogenous insulin production in patients with newly diagnosed Type 1 Diabetes Mellitus (T1D). In a double-blind, placebo-controlled design, participants will receive either Ixekizumab or a placebo alongside their conventional therapy for a duration of 52 weeks, followed by a 3-year extension phase. The study aims to assess insulin production, glycemic control, and the presence of T1D auto-antibodies over time. A total of 127 patients will be enrolled across 17 centers in Sweden.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-45 who have been diagnosed with Type 1 diabetes within the last 100 days and have specific autoantibodies present.

Not a fit: Patients who have had Type 1 diabetes for more than 100 days or those outside the age range of 18-45 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance insulin production and improve glycemic control in patients with newly diagnosed Type 1 diabetes.

How similar studies have performed: While the approach of using Ixekizumab in T1D is novel, similar studies in psoriasis have shown promising results with this treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Borås and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type1 Diabetes MellitusType 1 diabetesNew-onsetMMTTIxekizumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.