Ixekizumab Diabetes Intervention Trial (I-DIT)

Sponsor
Göteborg University
Study ID
NCT04589325
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Type1 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Ixekizumab — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 9, 2022
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
127 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ixekizumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Residual insulin secretion [ Time Frame: 12 months ]

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