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Clinical Trial Details

Trial ID: L3799
Source ID: NCT05743244
Associated Drug: Abrocitinib 200 Mg Oral Tablet
Title: Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Abrocitinib 200 MG Oral Tablet|DRUG: Ritlecitinib|DRUG: Placebo
Outcome Measures: Primary: 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., 12 Months |
Sponsor/Collaborators: Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: Pfizer
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 78
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-19
Completion Date: 2027-06-30
Results First Posted:
Last Update Posted: 2024-10-21
Locations: Children's Hospital Orange County, Orange, California, 92868, United States|Stanford University, Palo Alto, California, 94304, United States|University of California- San Francisco, San Francisco, California, 94143, United States|Barbara Davis Center at University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Yale University School of Medicine, New Haven, Connecticut, 06511, United States|University of Florida, Gainesville, Florida, 32610, United States|University of Miami, Miami, Florida, 33136, United States|University of South Florida Diabetes Center, Tampa, Florida, 33612, United States|Emory Children's Center, Atlanta, Georgia, 30322, United States|Indiana University, Indianapolis, Indiana, 46202, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|The Children's Mercy Hospital, Kansas, Missouri, 64111, United States|UBMD Pediatrics, Buffalo, New York, 14203, United States|Columbia University-Naomi Berrie Diabetes Center, New York, New York, 10032, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|University of Texas Southwestern, Dallas, Texas, 75390, United States|University of Utah, Salt Lake City, Utah, 84112, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States
URL: https://clinicaltrials.gov/show/NCT05743244