Ixekizumab Diabetes Intervention Trial (I-DIT)

NCT04589325 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: IDIT001
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Type1 Diabetes Mellitus

Keywords

Type 1 diabetes; New-onset; MMTT; Ixekizumab

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (4)

• Mean Insulin dosage per kilo bodyweight for 24 hours

  12 months

• Time with glucose levels in range (3.9-10 mmol/L)

  12 months

• Time in hypoglycaemia (<3.9 mmol/L)

  12 months

• HbA1c

  12 months

Other Outcomes (13)

• Time in hypoglycaemia (<3.0 mmol/L)

  12 months

• Proinsulin/c-peptide ratio in serum as a measure of beta cell stress

  12 months

• Time in target (3.9-8 mmol/L)

  12 months

Study Arms (2)

Ixekizumab

EXPERIMENTAL

Drug: Ixekizumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

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.

Also known as: Taltz

Ixekizumab

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (17)

Södra Älvsborg Hospital

Borås, Sweden

Location

Falu Lasarett

Falun, Sweden

Location

Sahlgrenska University Hospital, Sahlgrenska

Gothenburg, Sweden

Location

Sahlgrenska University Hospital, Östra Hospital

Gothenburg, Sweden

Location

Länssjukhuset Ryhov

Jönköping, Sweden

Location

Karlstad lasarett

Karlstad, Sweden

Location

Kristianstad Hospital

Kristianstad, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Lund University Hospital

Lund, Sweden

Location

Vrinnevi Hospital

Norrköping, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Skaraborgs sjukhus

Skövde, Sweden

Location

Centrum för Diabetes,

Stockholm, Sweden

Location

Södersjukhuset Hospital

Stockholm, Sweden

Location

NU-Hospital Group

Uddevalla, Sweden

Location

Uppsala Academic Hospital

Uppsala, Sweden

Location

Varbergs sjukhus

Varberg, Sweden

Location

Related Publications (1)

• Seyed Ahmadi S, Korsgren O, Jansson PA, Lind M. Design and methods of the Ixekizumab Diabetes Intervention Trial (I-DIT): protocol for a phase 2, randomised, multicentre, placebo-controlled, double-blind trial of anti-interleukin 17 as a treatment option for adults with new-onset type 1 diabetes. BMJ Open. 2025 Nov 12;15(11):e103486. doi: 10.1136/bmjopen-2025-103486.

  PMID: 41224288 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 19, 2020
• Study Start: November 9, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (17)