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.
In this double-blind, placebo-controlled prospective trial, patients with newly diagnosed T1D will be randomized to receive either Ixekizumab or placebo in addition to their conventional therapy. The primary aim is to examine the effect of Ixekizumab on endogenous insulin production when administered to persons with newly diagnosed T1D. The planned study duration is 52 weeks with an extension phase for 3 years and includes 127 patients at 17 centers in Sweden. During the extension phase the participants will be examined during a visit after 1 and 3 years after the end of the study regarding insulin production (C-peptide and proinsulin secretion during a Mixed Meal Tolerance Test), glycaemic control, T1D auto-antibodies and insulin doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
127
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.
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.
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
...and 7 more locations
Residual insulin secretion
Change in residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile measured by Mixed Meal Tolerance Test (MMTT) between baseline and week 52.
Time frame: 12 months
Mean Insulin dosage per kilo bodyweight for 24 hours
Change in mean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52.
Time frame: 12 months
Time with glucose levels in range (3.9-10 mmol/L)
Change in time with glucose levels in range (3.9-10 mmol/l) measured by CGM/FGM from baseline to week 52.
Time frame: 12 months
Time in hypoglycaemia (<3.9 mmol/L)
Change in time in hypoglycaemia (\<3.9 mmol/L) measured by CGM/FGM from baseline to week 52.
Time frame: 12 months
HbA1c
Difference in HbA1c from baseline to week 52.
Time frame: 12 months
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