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Diabetes Mellitus, Type 1Phase 2NCT05743244

Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

A Phase 2 study testing Abrocitinib 200 MG Oral Tablet and Ritlecitinib in people with Diabetes Mellitus, Type 1, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 30 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 35 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Abrocitinib 200 MG Oral Tablet and Ritlecitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
30 sitesin 3 countries
Study dates
19 Oct 2023to 30 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Provide informed consent or assent as appropriate and, if < 18 years of age have a parent or legal guardian provide informed consent
  • Age 12-35 years (both inclusive) at the time of signing informed consent and assent
  • Diagnosis of T1D within 100 days of the baseline visit (V0).
  • 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
  • Stimulated C-peptide of ≥0.2 pmol/mL measured during mixed-meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes
  • HbA1c ≤ 10 %
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  • Body weight ≥ 35kg at screening
  • Willing to comply with intensive diabetes management and wear a Continuous Glucose Monitoring Device (CGM)
  • 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 37 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 37 days of the baseline visit (V0).
  • Participants who are CMV and/or EBV seropositive at screening must be CMV PCR negative and/or EBV PCR <2,000 IU/mL and must have no signs or symptoms of acute infection at the time of the baseline visit (V0).
  • Be up to date on recommended vaccinations based on age of participants*
  • Participants are required to receive killed influenza vaccination at least 2 weeks prior to the baseline visit (V0) when vaccine for the current or upcoming flu season is available.
  • Enrollment must be delayed at least 4 weeks from administration of a killed vaccine other than influenza and COVID-19 and 6 weeks from a live vaccination. Live vaccinations and non-live vaccinations (other than influzena and COVID-19) should not be given while on study drug and be postponed at least 3 months after the last dose of study drug.
  • If participant is female with reproductive potential, she must have a negative pregnancy test at screening and be willing to avoid pregnancy using a highly-effective contraceptive method for the duration of the study
  • Males of reproductive age must use a highly-effective contraceptive method during the treatment phase and for 3 months following last dose of study drug
  • For COVID-19 vaccination, all participants will be strongly encouraged to be up-to-date with COVID-19 vaccine (s) as indicated by country-specific guidelines at least 2 weeks prior to the baseline visit (V0). HPV vaccine initiation and/or completion of series may be delayed until after completion of study drug in both adult and pediatric participants.

Who cannot join

  • Current or ongoing use of non-insulin pharmaceuticals or medication that affect glycemic control or glucose homeostasis within 7 days prior to screening or any prohibited concomitant medication listed in section 4.8
  • Untreated hypothyroidism or active Graves' disease
  • Concurrent treatment with other immunosuppressive agents (including biologics or steroids), other than inhaled or topical glucocorticoids
  • Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 1 month prior to Day 0 or superficial skin infection within 1 week prior to Day 0
  • Active acute or chronic infection requiring treatment with intravenous therapy (IV) within a minimum 1 month prior to Day 0
  • Specific cases should be reviewed by Infectious Disease Committee prior to enrollment
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  • Have active signs or symptoms of acute infection at the time of the baseline visit (V0).
  • Significant trauma or major surgery within 1 month of signing informed consent.
  • Considered in imminent need for surgery or with elective surgery scheduled to occur during the study
  • History of disseminated herpes zoster or disseminated herpes simplex or a recurrent (more than one episode of) localized, dermatomal herpes zoster
  • Have evidence of prior or current tuberculosis infection as assessed by Purified Protein Derivative (PPD), interferon gamma release assay (IGRA) or by history
  • Have evidence of current or past HIV or Hepatitis B infection
  • Have evidence of active Hepatitis C infection
  • Have current, confirmed COVID-19 infection
  • Current or history of Deep vein thrombosis (DVT), Pulmonary embolism (PE), or other thromboembolic events or history of inherited coagulopathies
  • First degree relative with a history of unprovoked venous thromboembolism (i.e. without known underlying cause such as trauma, surgery, immobilization, prolonged travel, pregnancy, hormone use, or plaster cast), which suggests that a participant may be at increased risk of inherited coagulation disorder
  • Any present malignancies or history of malignancy, other than a successfully treated nonmelanoma skin cancer
  • History of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease
  • Known or suspected polymorphism in the Cytochrome P450 2C19 (CYP2C19 gene, resulting in classification as a poor CYP2C19 metabolizer).
  • Have renal impairment (eGFR< 60 mL/min)
  • Currently on anti-platelet therapies, excluding low dose aspirin
  • One or more screening laboratory values as stated
  • Neutrophils < 1,500 /μL
  • Lymphocytes < 800 /μL
  • Platelets < 150,000 / μL
  • Hemoglobin < 6.2 mmol/L (10.0 g/dL)
  • Potassium > 5.5 mmol/L or <3.0 mmol/L
  • Sodium > 150mmol/L or < 130mmol/L
  • AST or ALT ≥ 2.5 times the upper limit of normal
  • Bilirubin ≥ 1.5 times upper limit of normal unless diagnosed with Gilbert's syndrome
  • LDL >160 mg/dL
  • Troponin I above the upper limit of normal
  • 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)
  • Be currently pregnant or lactating or anticipate becoming pregnant during the study
  • 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
  • Be currently participating in another T1D treatment study
  • Have had previous clinical use of Tzield (Teplizumab) not part of a T1D treatment study.
  • 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
  • Participants with hearing aids will be allowed to enter the study provided their hearing impairment is considered controlled/clinically stable.
  • 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
  • ANY of the following conditions at screening:
  • 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).
  • Long QT Syndrome, a family history of Long QT Syndrome, or a history of Torsades de Pointes (TdP).
  • History of chronic alcohol abuse or intravenous drug abuse or other illicit drug abuse within 2 years prior to screening
  • Current or past use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day
  • 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
  • Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk
  • Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results

Trial locations and contacts

30 sites in 3 countries.

30 sites in 3 countries

United States23 sites

  • Emory Children's Center

    Atlanta, Georgia, 30322

  • Barbara Davis Center at University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • UBMD Pediatrics

    Buffalo, New York, 14203

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • University of Florida

    Gainesville, Florida, 32610

  • Indiana University

    Indianapolis, Indiana, 46202

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64111

  • University of Louisville Pediatric Endocrinology

    Louisville, Kentucky, 40202

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

  • Columbia University-Naomi Berrie Diabetes Center

    New York, New York, 10032

  • Children's Hospital Orange County

    Orange, California, 92868

  • Stanford University

    Palo Alto, California, 94304

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • University of Utah

    Salt Lake City, Utah, 84112

  • University of California- San Francisco

    San Francisco, California, 94143

  • Benaroya Research Institute

    Seattle, Washington, 98101

  • Joslin Center at SUNY Upsate

    Syracuse, New York, 13210

  • University of South Florida Diabetes Center

    Tampa, Florida, 33612

Other trials in United States

Australia6 sites

  • Women and Children's Hospital-Adelaide

    Adelaide, South Australia, 5006

  • The Royal Children's Hospital - Melbourne

    Melbourne, Victoria, 3052

  • Perth Children's Hospital

    Nedlands, Western Australia, 6009

  • 3. Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101

Other trials in Australia

Canada1 site

  • Hospital for Sick Children

    Toronto, Ontario, M5G1X8

Other trials in Canada

About this study

Official title: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic β Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus

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.

Read the detailed 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.

Being tested
Abrocitinib 200 MG Oral Tablet, Ritlecitinib, Placebo
Keywords
TrialNet, T1D
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abrocitinib 200 MG Oral TabletDrug

    Also called CIBINQO

    Abrocitinib

  • RitlecitinibDrug

    Ritlecitinib

  • PlaceboDrug

    Placebo for Abrocitinib or Ritlecitinib

Study groups in NCT05743244
Study groupRoleWhat they receive
AbrocitinibExperimentalAbrocitinib will be self-administered as 200-milligram (mg) tablet daily for 52 weeks (12 months). The final prepared product is to be labeled to protect the blind.
Receives: Drug: Abrocitinib 200 MG Oral Tablet
RitlecitinibExperimentalRitlecitnib will be self-administered via oral administration as a 100-mg capsule daily for 52 weeks (12 months). The final prepared product is to be labeled to protect the blind.
Receives: Drug: Ritlecitinib
PlaceboPlacebo comparator200 mg tablet or 100 mg capsule matching either abrocitinib or ritlecitinib will be self-administered via oral administration daily for 52 weeks (12 months). The final product is to be labeled to protect the blind.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The area under the stimulated C-peptide curve (Y_AUC)

    The primary outcome of interest is the area under the stimulated C-peptide curve over the 2-hour mixed meal glucose tolerance test conducted at the 12-month visit (Y_AUC) over the 2-hour mixed meal glucose tolerance test conducted at the 12-month visit.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start19 Oct 2023
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants aged 12-35 years will be randomized 1:1:1 to receive abrocitinib, ritlecitinib, and placebo. The planned design is to enroll 26 participants in each of the 3 arms: the abrocitinib arm, the ritlecitinib arm, and the shared placebo arm. Within the shared placebo arm, participants will be randomized 1:1 to receive placebo matched to abrocitinib or placebo matched to ritlecitinib. Randomization will be stratified by the following two age categories: 12-17 years old, and 18 years or above. Within each stratum, participants will be randomized to either the abrocitinib arm, ritlecitinib arm, or the shared placebo arm using random block sizes. The total number of enrolled participants from the older age stratum (18 years or above) will be limited to 33 to replicate the age distribution in previous new-onset trials. Participants will receive 12 months of active treatment with abrocitinib, ritlecitinib, or placebo then enter a follow-up period of up to 12 months.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05743244
Sponsor's protocol ID
TN31 JAK Inhibitors
Status last verified
Aug 2026
First submitted
3 Feb 2023
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be available at the NIDDK Central Repository

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abrocitinib 200 MG Oral Tablet and Ritlecitinib in people with Diabetes Mellitus, Type 1, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 30 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The area under the stimulated C-peptide curve (Y_AUC) (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05743244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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