Could a psoriasis drug help save Insulin-Making cells in type 1 diabetes?
NCT ID NCT04589325
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether ixekizumab (Taltz), a drug already approved for psoriasis, can help people newly diagnosed with type 1 diabetes keep making their own insulin. The study involves 127 adults aged 18-45 who were diagnosed within the last 100 days. Participants receive either the drug or a placebo for 12 months, and researchers measure how much insulin their bodies still produce after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ixekizumab (Taltz)
- What this could lead to
- If it works, this could point toward a treatment that helps people with new-onset type 1 diabetes keep making their own insulin longer.
- What could go wrong
- This is an early phase 2 trial with only 127 participants, so results may not apply to everyone. The drug also has known risks like infections and allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 127 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centrum för Diabetes,
Stockholm, Sweden
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Falu Lasarett
Falun, Sweden
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Karlstad lasarett
Karlstad, Sweden
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Kristianstad Hospital
Kristianstad, Sweden
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Linköping University Hospital
Linköping, Sweden
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Lund University Hospital
Lund, Sweden
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Länssjukhuset Ryhov
Jönköping, Sweden
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NU-Hospital Group
Uddevalla, Sweden
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Sahlgrenska University Hospital, Sahlgrenska
Gothenburg, Sweden
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Sahlgrenska University Hospital, Östra Hospital
Gothenburg, Sweden
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Skaraborgs sjukhus
Skövde, Sweden
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Södersjukhuset Hospital
Stockholm, Sweden
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Södra Älvsborg Hospital
Borås, Sweden
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Uppsala Academic Hospital
Uppsala, Sweden
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Varbergs sjukhus
Varberg, Sweden
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Vrinnevi Hospital
Norrköping, Sweden
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Örebro University Hospital
Örebro, Sweden
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