Siplizumab in T1DM
Principal Investigator
Stephen Gitelman | University of California San Francisco | San Francisco, CA
Locations
Stanford School of Medicine: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes | Stanford,CA
Sanford Research | Sioux Falls,SD
Children's Mercy Hospital and Clinics: Section of Pediatric Endocrinology | Kansas City,MO
Indiana University Medical Center: Riley Hospital for Children, Department of Pediatric Endocrinology | Indianapolis,IN
University of Chicago - Kovler Diabetes Center | Chicago,IL
Harvard School of Medicine: Joslin Diabetes Center | Boston,MA
Columbia University Medical Center: Naomi Berrie Diabetes Center | New York,NY
University of Buffalo MD Pediatrics | Buffalo,NY
Emory University Dept of Pediatrics, Div Endocrinology | Atlanta,GA
University of Alabama at Birmingham | Birmingham,AL
UCSF School of Medicine: UCSF Diabetes Clinic | San Francisco,CA
University of Florida: Diabetes Center of Excellence | Gainesville,FL
University of South Florida Diabetes Center | Tampa,FL
University of Miami Miller School of Medicine: Diabetes Research Institute | Miami,FL
University of Minnesota Medical School: Division of Pediatric Endocrinology and Diabetes | Minneapolis,MN
Children's Hospital of Philadelphia | Philadelphia,PA
Study Code
ITN095AI
Study Status
Analysis
Abstract
The primary objective of the DESIGNATE study is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes mellitus (T1DM) that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM.
Participants will be age 8-45 and within 18 months of T1DM diagnosis.
DESIGNATE is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in new onset T1DM.
Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs. Blood samples for mechanistic analyses will be obtained during the treatment phase and thereafter. Adults aged 18- 45 will be enrolled initially at the study sites.
Qualification
You may be eligible to participate in the DESIGNATE Study if you:
- Are between the ages of 8 and 45
- Have been diagnosed with type 1 diabetes within the last 18 months
- Are in good general health
