The Effect of Anti-IL17 in New-onset Type 1 Diabetes: a Randomized, Double-blind, Placebo-controlled 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.
• 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
‣ Highly effective methods of contraception (use 1 form):
• combined oral contraceptive pill and mini-pill
∙ NuvaRing®
∙ implantable contraceptives
∙ injectable contraceptives (such as Depo-Provera®)
∙ intrauterine device (such as Mirena® and ParaGard®)
∙ contraceptive patch-ONLY women \<198 pounds or 90 kg
∙ abstinence from sex
∙ vasectomy-for men in clinical studies
⁃ 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 \[also referred to as congenital absence of the uterus and vagina\])