Siplizumab for Type 1 Diabetes (DESIGNATE Trial)
Palo Alto (17 mi)Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0. 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. If indicated, participants will enter into long-term safety monitoring for up to an additional 48 weeks. 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.
The primary objective is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM.
The secondary objectives are to:
1. Assess the safety profile of siplizumab in recently diagnosed T1DM.
2. Assess the effects of siplizumab on residual beta cell function in recently diagnosed T1DM participants.
Eligibility Criteria
This trial is for individuals aged 8-45 with Type 1 diabetes diagnosed within the last 18 months. They must have completed their primary COVID-19 vaccination series, not be on certain diabetes or immunosuppressive medications, and cannot have a history of severe reactions to monoclonal antibodies or significant cardiovascular disease.Inclusion Criteria
I am between 8 and 45 years old.
I have diabetes and tested positive for a diabetes-related autoantibody.
Exclusion Criteria
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
I have a history of serious heart problems.
I have used treatments that could affect my type 1 diabetes or immune system.
I have been diagnosed with cancer before or have it now.
I have not had any serious infections or HIV, hepatitis B or C, TB, EBV, CMV, or COVID-19 recently.
I have had a bone marrow transplant or an autoimmune disease that affects my white blood cells.
Treatment Details
The study tests different doses of Siplizumab in patients with Type 1 diabetes. Participants will receive weekly doses for 12 weeks and then be monitored up to one year. The goal is to find a safe dose that affects T cell behavior similar to another therapy (alefacept) and preserves insulin-producing cells.
8Treatment groups
Experimental Treatment
Group I: Children with T1D 0.22 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 2 Group 4: 0.22 mg/kg SQ dose for a total of 12 weeks
Group II: Children with T1D 0.18 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 2 Group 3: 0.18 mg/kg SQ dose for a total of 12 weeks
Group III: Children with T1D 0.12 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 2 Group 2:0.12 mg/kg SQ dose for a total of 12 weeks
Group IV: Children with T1D 0.08 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 2 Group 1:0.08 mg/kg SQ dose for a total of 12 weeks
Group V: Adults with T1D 0.22 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 1 Group 4: 0.22 mg/kg SQ dose for a total of 12 weeks
Group VI: Adults with T1D 0.18 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 1 Group 3:0.18 mg/kg SQ dose for a total of 12 weeks
Group VII: Adults with T1D 0.12 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 1 Group 2: 0.12 mg/kg SQ dose for a total of 12 weeks
Group VIII: Adults with T1D 0.08 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 1 Group1: 0.08 mg/kg SQ dose for a total of 12 weeks
Find a clinic near you
Research locations nearbySelect from list below to view details:
Sanford Health, Sanford Research CenterSioux Falls, SD
University of South Florida: Diabetes CenterTampa, FL
Indiana University Medical Center: Riley Hospital for Children, Department of Pediatric Endocrinology & DiabetologyIndianapolis, IN
University of Iowa Children's Hospital: Department of Pediatrics, Pediatric Endocrinology and DiabetesIowa City, IA
More Trial Locations
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor