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

Part of paid clinical trials in Orange, California.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT05743244
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Abrocitinib 200 MG Oral Tablet — DRUG
    Abrocitinib
  • Ritlecitinib — DRUG
    Ritlecitinib
  • Placebo — DRUG
    Placebo for Abrocitinib or Ritlecitinib

Study Details

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.

Key Dates

Start date
Oct 19, 2023
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: Abrocitinib
    Abrocitinib 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.
  • Experimental: Ritlecitinib
    Ritlecitnib 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.
  • Placebo Comparator: Placebo
    200 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.

Primary Outcome Measure

The area under the stimulated C-peptide curve (Y_AUC) [ Time Frame: 12 Months ]

Locations (23)

FacilityCityStateZIPSite coordinators
Children's Hospital Orange CountyOrangeCalifornia92868-
Stanford UniversityPalo AltoCalifornia94304-
University of California- San FranciscoSan FranciscoCalifornia94143-
Barbara Davis Center at University of Colorado Anschutz Medical CampusAuroraColorado80045-
Yale University School of MedicineNew HavenConnecticut06511-
University of FloridaGainesvilleFlorida32610-
University of MiamiMiamiFlorida33136-
University of South Florida Diabetes CenterTampaFlorida33612-
Emory Children's CenterAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60637-
Indiana UniversityIndianapolisIndiana46202-
University of Louisville Pediatric EndocrinologyLouisvilleKentucky40202-
Joslin Diabetes CenterBostonMassachusetts02215-
University of MinnesotaMinneapolisMinnesota55455-
The Children's Mercy HospitalKansas CityMissouri64111-
UBMD PediatricsBuffaloNew York14203-
Columbia University-Naomi Berrie Diabetes CenterNew YorkNew York10032-
Joslin Center at SUNY UpsateSyracuseNew York13210-
University of PittsburghPittsburghPennsylvania15224-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Texas SouthwesternDallasTexas75390-
University of UtahSalt Lake CityUtah84112-
Benaroya Research InstituteSeattleWashington98101-

Find similar trials in Orange, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Children's Hospital Orange County· Orange, CAStanford University· Palo Alto, CAUniversity of California- San Francisco· San Francisco, CABarbara Davis Center at University of Colorado Anschutz Medical Campus· Aurora, COYale University School of Medicine· New Haven, CTUniversity of Florida· Gainesville, FL

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