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TN-31 JAKPOT T1D

  • Status
    Accepting Candidates
  • Age
    12 Years - 35 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.

Description

This study has a total sample size of 78 participants. Of that 78, 52 participants will receive active treatment, and a total of 26 participants will receive placebo. Participants will receive 12 months of active treatment with abrocitinib, ritlecitinib, or placebo with up to 12 months of additional follow-up. During the study, participants will undergo frequent assessments of their insulin production, immunologic status, overall health and well-being and diabetes care.

Details

Full study title TN31 JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D (JAKPOT T1D) Study
Protocol number OCR44273
ClinicalTrials.gov ID NCT05743244
Phase Phase 2

Eligibility

Inclusion Criteria:

  1. Provide informed consent or assent as appropriate and, if < 18 years of age have a parent or legal guardian provide informed consent

  2. Age 12-35 years (both inclusive) at the time of signing informed consent and assent

  3. Diagnosis of T1D within 100 days of the baseline visit (V0. .

  4. Positive for at least one islet cell autoantibody; Glutamate decarboxylase (GAD)65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A

  5. Stimulated C-peptide of �0. 2 pmol/mL measured during mixed-meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes

  6. HbA1c � 10 %

  7. Body weight � 35kg at screening

  8. Willing to comply with intensive diabetes management and wear a Continuous Glucose Monitoring Device (CGM)

  9. Participants who are Cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) seronegative at screening must be CMV and/or EBV Polymerase chain reaction (PCR) negative within 30 days of randomization and may not have had signs or symptoms of a CMV and/or EBV-compatible illness lasting longer than 7 days within 30 days of the baseline visit (V0).

  10. Participants who are CMV and/or EBV seropositive at screening must be CMV PCR

negative and/or EBV PCR 160 mg/dL

  1. Vaccination with a live virus within the last 6 weeks and killed vaccine within 4

weeks (except 2 weeks for flu vaccine and COVID vaccine)

  1. Be currently pregnant or lactating or anticipate becoming pregnant during the study

  2. Male participants able to father children and female participants of childbearing

potential who are unwilling or unable to use 2 effective methods (at least 1 highly

effective method) of contraception, including abstinence, as outlined in this

protocol for the duration of the study and for at least 3 months after the last dose

of investigational product

  1. Be currently participating in another T1D treatment study

  2. Have hearing loss with progression over the previous 5 years, or sudden hearing

loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's

disease, labyrinthitis, or other auditory condition that is considered acute,

fluctuating, or progressive

  1. Acute coronary syndrome (e.g., myocardial infarction, unstable angina pectoris) and

any history of cerebrovascular disease within 24 weeks before screening; Heart

failure NYHA (New York Heart Association) III, NYHA IV

  1. ANY of the following conditions at screening:

a. Screening 12-lead electrocardiogram (ECG) that demonstrates: i. Clinically

significant abnormalities requiring treatment (eg, acute myocardial infarction,

serious tachy* or brady-arrhythmias) or indicating serious underlying heart disease

(eg, cardiomyopathy, Wolff-Parkinson* White syndrome); ii. Confirmed QT corrected

using Fridericia's correction factor (QTcF) prolongation (>450 milliseconds).

b. Long QT Syndrome, a family history of Long QT Syndrome, or a history of Torsades

de Pointes (TdP).

  1. History of chronic alcohol abuse or intravenous drug abuse or other illicit drug

abuse within 2 years prior to screening

  1. Current or past use of tobacco or nicotine containing products more than the

equivalent of 5 cigarettes per day

  1. Participant is the investigator or any sub-investigator, research assistant,

pharmacist, study coordinator, other staff or relative thereof directly involved in

the conduct of the trial

  1. Have any complicating medical issues or abnormal clinical laboratory results that

may interfere with study conduct, or cause increased risk

  1. Any condition that in the investigator's opinion may adversely affect study

participation or may compromise the study results

Lead researchers

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  1. Step
    1

    Contact the research team

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  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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