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Siplizumab in T1DM (DESIGNATE)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Siplizumab
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring diabetic, Type 1 diabetes, T1DM, siplizumab

Eligibility Criteria

8 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ability to provide informed consent (parental permission and informed assent of minor, if applicable)
  2. Diagnosis of Type 1 Diabetes Mellitus (T1DM) within 18 months (550 days) of enrollment (V0)
  3. Positive for at least one diabetes-related autoantibody including:

    1. Glutamate decarboxylase (GAD-65)
    2. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
    3. Insulinoma antigen-2 (IA-2)
    4. Zinc transporter-8 (ZnT8)
  4. Peak stimulated C-peptide level > 0.15 pmol/mL following a mixed- meal tolerance test (MMTT) conducted >= 21 days from diagnosis and within 37 days of enrollment (V0)
  5. Completion of a primary SARS-CoV-2 vaccination series, including any additional vaccine dose(s) for which the participant qualifies for, according to current The Centers for Disease Control and Prevention (CDC) recommendations and FDA approval(s) or emergency use authorization(s). If the participant requires administration of vaccine(s) to meet eligibility requirements, they must complete the vaccination series at least 2 weeks prior to enrollment (V0)

Exclusion Criteria:

  1. Use of investigational drugs within 24 weeks of participation with the exception of any vaccine for the prevention of SARS-CoV2 infection and emergency use authorization medications for treating SARS- CoV2
  2. Severe reaction or anaphylaxis to humanized monoclonal antibodies
  3. History of significant allergy (e.g. anaphylaxis) to milk or soy proteins
  4. History of recent (within 180 days of V0) or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, including:

    1. Human immunodeficiency virus (HIV)
    2. Current or prior infection with hepatitis B (HBV), as indicated by positive HBsAg or positive HBcAb
    3. Current or prior hepatitis C (HCV), unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 12 weeks after cessation of therapy)
    4. Positive Quantiferon-TB Gold or Quantiferon-TB Gold Plus tests. PPD or T-SPOT (R). TB may be substituted for the Quantiferon-TB Gold or Quantiferon-TB Gold Plus tests
    5. Active infection with Epstein-Barr virus (EBV) as detected by Polymerase Chain Reaction (PCR) or serology at the screening visit (V-1)
    6. Active infection with cytomegalovirus (CMV) as detected by PCR or serology at the screening visit (V-1)
  5. Positive molecular testing of SARS-CoV-2 within 21 days of V-1
  6. Any of the following laboratory abnormalities within 37 days of enrollment (V0), confirmed by repeat tests at least 1 week apart:

    1. White blood count (WBC) < 3 x 10^3/µL
    2. CD4+ count below the lower limit of normal
    3. Platelet count <150,000 /µL
    4. Hemoglobin < 10 g/dL
    5. ALT >= 2x upper limit of normal (ULN) or
    6. AST >= 2x ULN
  7. Prior or current treatment that is known to alter the natural history of Type 1 Diabetes Mellitus (T1DM) or immunologic status, including high dose inhaled, extensive topical or systemic glucocorticoids
  8. Current or prior (within last 14 days of the V-1 mixed meal tolerance test (MMTT)) use of any medication known to influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, thiazide, or other potassium- depleting diuretics, ß-adrenergic blockers, niacin)
  9. Current or prior (within the last 30 days of the V-1 MMTT) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin
  10. Previous or current diagnosis of malignancy
  11. History of bone marrow transplantation, or autoimmune disease associated with lymphopenia
  12. History or diagnoses of other autoimmune diseases with the exception of stable thyroid or celiac disease
  13. History of significant cardiovascular disease
  14. Vaccination with a live attenuated vaccine (e.g., varicella, measles, mumps, rubella, coldattenuated intranasal influenza vaccine, bacillus Calmette- Guérin, and smallpox) within 30 days of V0
  15. Women of child-bearing potential who are unwilling to use a medically acceptable form of contraception from 14 days prior to V0 until study Week 52
  16. Women who are pregnant, lactating, or planning on pregnancy during the study
  17. Current, diagnosed mental illness (e.g. severe depression), current diagnosed or self-reported drug, or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
  18. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study

Sites / Locations

  • University of Alabama at Birmingham: Division of Endocrinology, Diabetes and MetabolismRecruiting
  • UCSF School of Medicine: UCSF Diabetes ClinicRecruiting
  • Stanford School of Medicine: Department of Pediatrics, Division of Pediatric Endocrinology and DiabetesRecruiting
  • University of Colorado School of Medicine: Barbara Davis Center for DiabetesRecruiting
  • University of Florida: Diabetes Center of ExcellenceRecruiting
  • University of Miami Miller School of Medicine: Diabetes Research InstituteRecruiting
  • University of South Florida: Diabetes CenterRecruiting
  • Emory University School of Medicine: Emory & Children's Pediatric Research Center, Division of Endocrinology & DiabetesRecruiting
  • The University of Chicago: Duchossois Center for Academic Medicine-Hyde ParkRecruiting
  • Indiana University Medical Center: Riley Hospital for Children, Department of Pediatric Endocrinology & DiabetologyRecruiting
  • University of Iowa Children's Hospital: Department of Pediatrics, Pediatric Endocrinology and DiabetesRecruiting
  • Joslin Diabetes Center: Joslin ClinicRecruiting
  • University of Minnesota Medical School: Division of Pediatric Endocrinology and DiabetesRecruiting
  • Children's Mercy Hospitals and Clinics: Section of Pediatric Endocrinology and Diabetes
  • University at Buffalo, Department of Pediatrics: Division of Endocrinology and DiabetesRecruiting
  • Columbia University Medical Center: Naomi Berrie Diabetes CenterRecruiting
  • Children's Hospital of Philadelphia: Diabetes Center for ChildrenRecruiting
  • Sanford Health, Sanford Research CenterRecruiting
  • University of Texas Southwestern Medical Center: Department of Internal Medicine, Division of Endocrinology
  • Benaroya Research Institute at Virginia Mason: Diabetes Research ProgramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Adults with T1D 0.08 mg/kg SQ dose

Adults with T1D 0.12 mg/kg SQ dose

Adults with T1D 0.18 mg/kg SQ dose

Adults with T1D 0.22 mg/kg SQ dose

Children with T1D 0.08 mg/kg SQ dose

Children with T1D 0.12 mg/kg SQ dose

Children with T1D 0.18 mg/kg SQ dose

Children with T1D 0.22 mg/kg SQ dose

Arm Description

Cohort 1 Group1: 0.08 mg/kg SQ dose for a total of 12 weeks

Cohort 1 Group 2: 0.12 mg/kg SQ dose for a total of 12 weeks

Cohort 1 Group 3:0.18 mg/kg SQ dose for a total of 12 weeks

Cohort 1 Group 4: 0.22 mg/kg SQ dose for a total of 12 weeks

Cohort 2 Group 1:0.08 mg/kg SQ dose for a total of 12 weeks

Cohort 2 Group 2:0.12 mg/kg SQ dose for a total of 12 weeks

Cohort 2 Group 3: 0.18 mg/kg SQ dose for a total of 12 weeks

Cohort 2 Group 4: 0.22 mg/kg SQ dose for a total of 12 weeks

Outcomes

Primary Outcome Measures

Acceptable T cell phenotype signature by the change from baseline in the Programmed Cell Death 1 (PD1) during first 12 weeks.
Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature based on the 20% increase or greater from baseline in PD1. The primary analysis will identify siplizumab doses with acceptable safety profiles and favorable changes in the T cell phenotype in each age cohort. The primary assessments will be made during the first 12 weeks with an interim analysis for futility after 5th per protocol participant (PP) per dosing arm reaches Week 12 in each age cohort.
Acceptable T cell phenotype signature by the change from baseline in the T cell immunoreceptor with Ig and ITIM domains (TIGIT) during first 12 weeks.
Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature based on the 20% increase or greater from baseline in TIGIT. The primary analysis will identify siplizumab doses with acceptable safety profiles and favorable changes in the T cell phenotype in each age cohort. The primary assessments will be made during the first 12 weeks with an interim analysis for futility after 5 PP per dosing arm reach Week 12 in each age cohort.
Acceptable T cell phenotype signature by the change from Baseline in the frequency within circulating cluster of differentiation 4 (CD4) Tem cells during first 12 weeks.
Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature based on the 20% increase or greater from baseline in frequency on CD4 Tem. The primary analysis will identify siplizumab doses with acceptable safety profiles and favorable changes in the T cell phenotype in each age cohort. The primary assessments will be made during the first 12 weeks with an interim analysis for futility after 5 PP per dosing arm reach Week 12 in each age cohort.
Acceptable T cell phenotype signature by the change from baseline in the CD4 Treg/Tem ratio
Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature based on the 75% increase or greater from baseline in the Treg/Tem ratio

Secondary Outcome Measures

Frequency of Adverse Event (AEs) in all siplizumab dosing arms
AE will include any untoward medical occurrence associated with siplizumab administration or any study-mandated procedure
Mixed Meal Tolerance Test (MMTT)-stimulated mean 2-hour C-peptide AUC
The mean 2-hour C-peptide AUC, measured in pmol/ml, is computed by dividing the total AUC by 120 minutes
Insulin use (U/kg/day)
Measured as U/kg body weight/day; participants should record the type and amount of insulin they have used during the 5-day period immediately preceding the beginning of treatment, middle of treatment, end of treatment, and at all follow-up visits

Full Information

First Posted
September 19, 2022
Last Updated
October 18, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05574335
Brief Title
Siplizumab in T1DM
Acronym
DESIGNATE
Official Title
A T Cell Phenotype Signature Driven Dose Finding Study With Siplizumab in Type 1 Diabetes Mellitus (ITN095AI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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: Assess the safety profile of siplizumab in recently diagnosed T1DM. Assess the effects of siplizumab on residual beta cell function in recently diagnosed T1DM participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
diabetic, Type 1 diabetes, T1DM, siplizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults with T1D 0.08 mg/kg SQ dose
Arm Type
Experimental
Arm Description
Cohort 1 Group1: 0.08 mg/kg SQ dose for a total of 12 weeks
Arm Title
Adults with T1D 0.12 mg/kg SQ dose
Arm Type
Experimental
Arm Description
Cohort 1 Group 2: 0.12 mg/kg SQ dose for a total of 12 weeks
Arm Title
Adults with T1D 0.18 mg/kg SQ dose
Arm Type
Experimental
Arm Description
Cohort 1 Group 3:0.18 mg/kg SQ dose for a total of 12 weeks
Arm Title
Adults with T1D 0.22 mg/kg SQ dose
Arm Type
Experimental
Arm Description
Cohort 1 Group 4: 0.22 mg/kg SQ dose for a total of 12 weeks
Arm Title
Children with T1D 0.08 mg/kg SQ dose
Arm Type
Experimental
Arm Description
Cohort 2 Group 1:0.08 mg/kg SQ dose for a total of 12 weeks
Arm Title
Children with T1D 0.12 mg/kg SQ dose
Arm Type
Experimental
Arm Description
Cohort 2 Group 2:0.12 mg/kg SQ dose for a total of 12 weeks
Arm Title
Children with T1D 0.18 mg/kg SQ dose
Arm Type
Experimental
Arm Description
Cohort 2 Group 3: 0.18 mg/kg SQ dose for a total of 12 weeks
Arm Title
Children with T1D 0.22 mg/kg SQ dose
Arm Type
Experimental
Arm Description
Cohort 2 Group 4: 0.22 mg/kg SQ dose for a total of 12 weeks
Intervention Type
Drug
Intervention Name(s)
Siplizumab
Other Intervention Name(s)
TCD 601
Intervention Description
Weekly siplizumab doses for a total of 12 weeks
Primary Outcome Measure Information:
Title
Acceptable T cell phenotype signature by the change from baseline in the Programmed Cell Death 1 (PD1) during first 12 weeks.
Description
Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature based on the 20% increase or greater from baseline in PD1. The primary analysis will identify siplizumab doses with acceptable safety profiles and favorable changes in the T cell phenotype in each age cohort. The primary assessments will be made during the first 12 weeks with an interim analysis for futility after 5th per protocol participant (PP) per dosing arm reaches Week 12 in each age cohort.
Time Frame
From week 0 (baseline) to week 12
Title
Acceptable T cell phenotype signature by the change from baseline in the T cell immunoreceptor with Ig and ITIM domains (TIGIT) during first 12 weeks.
Description
Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature based on the 20% increase or greater from baseline in TIGIT. The primary analysis will identify siplizumab doses with acceptable safety profiles and favorable changes in the T cell phenotype in each age cohort. The primary assessments will be made during the first 12 weeks with an interim analysis for futility after 5 PP per dosing arm reach Week 12 in each age cohort.
Time Frame
From week 0 (baseline) to week 12
Title
Acceptable T cell phenotype signature by the change from Baseline in the frequency within circulating cluster of differentiation 4 (CD4) Tem cells during first 12 weeks.
Description
Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature based on the 20% increase or greater from baseline in frequency on CD4 Tem. The primary analysis will identify siplizumab doses with acceptable safety profiles and favorable changes in the T cell phenotype in each age cohort. The primary assessments will be made during the first 12 weeks with an interim analysis for futility after 5 PP per dosing arm reach Week 12 in each age cohort.
Time Frame
From week 0 (baseline) to week 12
Title
Acceptable T cell phenotype signature by the change from baseline in the CD4 Treg/Tem ratio
Description
Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature based on the 75% increase or greater from baseline in the Treg/Tem ratio
Time Frame
From week 0 (baseline) to week 12
Secondary Outcome Measure Information:
Title
Frequency of Adverse Event (AEs) in all siplizumab dosing arms
Description
AE will include any untoward medical occurrence associated with siplizumab administration or any study-mandated procedure
Time Frame
From week 0 to week 52
Title
Mixed Meal Tolerance Test (MMTT)-stimulated mean 2-hour C-peptide AUC
Description
The mean 2-hour C-peptide AUC, measured in pmol/ml, is computed by dividing the total AUC by 120 minutes
Time Frame
At Week 12, 24, 36, 52
Title
Insulin use (U/kg/day)
Description
Measured as U/kg body weight/day; participants should record the type and amount of insulin they have used during the 5-day period immediately preceding the beginning of treatment, middle of treatment, end of treatment, and at all follow-up visits
Time Frame
At Weeks 6, 12, 24, 36 and 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to provide informed consent (parental permission and informed assent of minor, if applicable). Male or female between 8 to 45 years of age. Diagnosis of T1DM within 18 months (550 days) of enrollment (V0). Positive for at least one diabetes-related autoantibody, including: Glutamate decarboxylase (GAD-65), Insulin, if obtained within 10 days of the onset of exogenous insulin therapy, Insulinoma antigen-2 (IA-2), or Zinc transporter-8 (ZnT8). Peak stimulated C-peptide level > 0.15 pmol/mL following a MMTT conducted ≥ 21 days from diagnosis and within 37 days of enrollment (V0). Completion of a primary SARS-CoV-2 vaccination series, including any additional vaccine dose(s) for which the participant qualifies, according to current CDC recommendations and FDA approval(s) or emergency use authorization(s). If the participant requires administration of vaccine(s) to meet eligibility requirements, they must complete the vaccination series at least 2 weeks prior to enrollment (V0). Exclusion Criteria: 1. Use of investigational drugs within 24 weeks of participation with the exception of any vaccine for the prevention of SARS-CoV-2 infection and emergency use authorization medications for treating SARS-CoV-2. Severe reaction or anaphylaxis to humanized monoclonal antibodies. History of significant allergy (e.g., anaphylaxis) to milk or soy proteins. History of recent (within 180 days of V0) or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, including: Human immunodeficiency virus (HIV), Current or prior infection with hepatitis B (HBV), as indicated by positive HBsAg or positive HBcAb, Current or prior hepatitis C (HCV), unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 12 weeks after cessation of therapy), Positive QuantiFERON-TB Gold or QuantiFERON-TB Gold Plus tests. PPD or T-SPOT®.TB may be substituted for the QuantiFERON-TB Gold or QuantiFERON-TB Gold Plus tests, Active infection with EBV as detected by PCR or serology at the screening visit (V-1), Active infection with cytomegalovirus (CMV) as detected by PCR or serology at the screening visit (V-1), Positive molecular testing of SARS-CoV-2 within 30 days of V-1. Any of the following laboratory abnormalities within 37 days of enrollment (V0), confirmed by repeat tests at least 1 week apart: White blood count (WBC) < 3 x 103/μL;, CD4+ count below the lower limit of normal, Platelet count < 150,000 /μL, Hemoglobin < 10 g/dL, ALT ≥ 2x upper limit of normal (ULN) or AST ≥ 2x ULN Serum creatinine >1.5x ULN in adults or >ULN in pediatrics.. Prior or current treatment that is known to alter the natural history of T1DM or immunologic status, including high dose inhaled, extensive topical or systemic glucocorticoids. Current or prior (within last 14 days of the V-1 MMTT) use of any medication known to influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, thiazide, or other potassium-depleting diuretics, β-adrenergic blockers, niacin). Current or prior (within the last 30 days of the V-1 MMTT) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin. Previous or current diagnosis of malignancy. History of bone marrow transplantation, or autoimmune disease associated with lymphopenia. History or diagnoses of other autoimmune diseases with the exception of stable thyroid or celiac disease. History of significant cardiovascular disease. Vaccination with a live attenuated vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette- Guérin, and smallpox) within 30 days of V0. Women of child-bearing potential who are unwilling to use a medically acceptable form of contraception from 14 days prior to V0 until study Week 52. Women who are pregnant, lactating, or planning on pregnancy during the study. Current, diagnosed mental illness (e.g., severe depression), current diagnosed or self-reported drug, or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Gitelman, M.D.
Organizational Affiliation
University of California San Francisco, School of Medicine: Diabetes Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham: Division of Endocrinology, Diabetes and Metabolism
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alason Koenig
Phone
205-388-4026
Email
alasonkoenig@uabmc.edu
Facility Name
UCSF School of Medicine: UCSF Diabetes Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Ellement
Phone
844-813-8273
Email
clinicalresearch@diabetes.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Stephen E. Gitelman
Facility Name
Stanford School of Medicine: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trudy Esrey, RD, CDCES
Phone
650-498-4450
Email
tesrey@stanford.edu
First Name & Middle Initial & Last Name & Degree
Darrell Wilson, MD
Facility Name
University of Colorado School of Medicine: Barbara Davis Center for Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hali Broncucia
Phone
303-724-7526
Email
hali.broncucia@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Peter Gottlieb, MD
Facility Name
University of Florida: Diabetes Center of Excellence
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Peeling
Phone
352-273-5275
Email
schatz@ufl.edu
First Name & Middle Initial & Last Name & Degree
Desmond Schatz, MD
Facility Name
University of Miami Miller School of Medicine: Diabetes Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Blaschke, MD
Phone
305-243-4485
Email
cblaschke@med.miami.edu
First Name & Middle Initial & Last Name & Degree
David Baidal, MD
Facility Name
University of South Florida: Diabetes Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Rodriguez, MD
Phone
813-821-8011
Email
hrodrig1@usf.edu
First Name & Middle Initial & Last Name & Degree
Henry Rodriguez, MD
Facility Name
Emory University School of Medicine: Emory & Children's Pediatric Research Center, Division of Endocrinology & Diabetes
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Felner
Phone
404-727-0637
Email
efelner@emory.edu
First Name & Middle Initial & Last Name & Degree
Eric Felner
Facility Name
The University of Chicago: Duchossois Center for Academic Medicine-Hyde Park
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Demetra Reyes
Phone
773-702-4802
Email
Demetra.Reyes@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Louis Philipson, MD, Ph.D
Facility Name
Indiana University Medical Center: Riley Hospital for Children, Department of Pediatric Endocrinology & Diabetology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Lease
Phone
317-278-2538
Email
hlease@iu.edu
Facility Name
University of Iowa Children's Hospital: Department of Pediatrics, Pediatric Endocrinology and Diabetes
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Hemann
Phone
866-309-0837
Email
pediatric-diabetes-research@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Michael Tansey, MD
Facility Name
Joslin Diabetes Center: Joslin Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kim
Phone
888-813-8669
Email
T1DTrials@joslin.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jason Gaglia, MD, MMSc
Facility Name
University of Minnesota Medical School: Division of Pediatric Endocrinology and Diabetes
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice Leschyshyn
Phone
612-626-8467
Email
lesch004@umn.edu
First Name & Middle Initial & Last Name & Degree
Antoinette Moran, MD
Facility Name
Children's Mercy Hospitals and Clinics: Section of Pediatric Endocrinology and Diabetes
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University at Buffalo, Department of Pediatrics: Division of Endocrinology and Diabetes
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda House
Phone
716-323-0075
Email
ahouse@upa.chob.edu
Facility Name
Columbia University Medical Center: Naomi Berrie Diabetes Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Schwab
Phone
212-851-5425
Email
berrietrials@cumc.columbia.edu
Facility Name
Children's Hospital of Philadelphia: Diabetes Center for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Mack
Phone
215-590-3122
Email
MACKMM@chop.edu
First Name & Middle Initial & Last Name & Degree
Steven Willi, MD
Facility Name
Sanford Health, Sanford Research Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Figg
Phone
605-312-1000
Email
DiabetesResearch@SanfordHealth.org
First Name & Middle Initial & Last Name & Degree
Kurt J. Griffin, MD, PhD
Facility Name
University of Texas Southwestern Medical Center: Department of Internal Medicine, Division of Endocrinology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Benaroya Research Institute at Virginia Mason: Diabetes Research Program
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinna Tordillos
Phone
206-341-8937
Email
ctordillos@benaroyaresearch.org
First Name & Middle Initial & Last Name & Degree
Sandra Lord, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
IPD Sharing Time Frame
On average, within 24 months after database lock for the trial.
IPD Sharing Access Criteria
Open access.
IPD Sharing URL
https://www.immport.org/home
Links:
URL
https://www.immunetolerance.org/
Description
Immune Tolerance Network (ITN)
URL
https://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID)
URL
https://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT)

Learn more about this trial

Siplizumab in T1DM

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