BridgeMD
A 12-month, randomized, single-blind, placebo-controlled exposure-response study of TCD601 (siplizumab) in new onset type 1 diabetes patients (STRIDE)
EU CTIS ID: 2023-506837-31-00
What this study is testing
The main objective is to determine the effect of 12 weeks of siplizumab treatment on beta-cell function in adults recently diagnosed with T1D compared to placebo at week 52.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able to understand the study requirements and provide written informed consent before any study assessment is performed.
- Male or female between 18 to 45 years of age.
- A diagnosis of T1D by a qualified healthcare provider based on ADA guidelines ≤ 100 days of randomization.
- Positive for at least one diabetes-related autoantibody against: Glutamate decarboxylase (GAD-65), Insulin, if obtained prior and up to 10 days of the onset of exogenous insulin therapy, Insulinoma antigen-2 (IA-2), Zinc transporter-8 (ZnT8), or Islet cell autoantibodies against cytoplasmic proteins in the beta cell (ICA).
- Peak stimulated C-peptide level >0.2 pmol/mL (200 pmol/L) following a two-hour mixed-meal tolerance test (MMTT) during Screening (Visit 1).
- Agreement to follow local, regional, or national guidelines for strict glycemic control with targets of HbA1c ≤ 53 mmol/mol (≤ 7.0%).
You likely can't join if
- Inability or unwillingness to provide written informed consent or comply with the study protocol.
- Previous or current diagnosis of malignancy, except adequately treated cervical carcinoma in situ and adequately treated non-metastatic basal and squamous cell carcinoma.
- History of bone marrow transplantation (BMT) / stem cell transplantation or solid organ transplantation.
- History or diagnoses of other autoimmune disease, including disease associated with lymphopenia, with the exception of stable thyroid or celiac disease.
- History of significant cardiovascular disease (including history of myocardial infarction, angina, use of anti-anginal medicines (e.g., nitroglycerin), or abnormal stress test).
- Vaccination with a live attenuated vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette- Guérin, and smallpox) within 28 days of dosing (Day 0).
See the full eligibility criteria
Who can join
- Able to understand the study requirements and provide written informed consent before any study assessment is performed.
- Male or female between 18 to 45 years of age.
- A diagnosis of T1D by a qualified healthcare provider based on ADA guidelines ≤ 100 days of randomization.
- Positive for at least one diabetes-related autoantibody against: Glutamate decarboxylase (GAD-65), Insulin, if obtained prior and up to 10 days of the onset of exogenous insulin therapy, Insulinoma antigen-2 (IA-2), Zinc transporter-8 (ZnT8), or Islet cell autoantibodies against cytoplasmic proteins in the beta cell (ICA).
- Peak stimulated C-peptide level >0.2 pmol/mL (200 pmol/L) following a two-hour mixed-meal tolerance test (MMTT) during Screening (Visit 1).
- Agreement to follow local, regional, or national guidelines for strict glycemic control with targets of HbA1c ≤ 53 mmol/mol (≤ 7.0%).
- Agreement to use CGM from screening until the end of the study/Week 52
- Up to date immunization status or agreement to receive routine immunizations according to current country and/or regional guidelines and agree to comply with the guidelines for immunosuppressed individuals and those with chronic disease prior to randomization and receipt of study drug.
What rules you out
- Inability or unwillingness to provide written informed consent or comply with the study protocol.
- Previous or current diagnosis of malignancy, except adequately treated cervical carcinoma in situ and adequately treated non-metastatic basal and squamous cell carcinoma.
- History of bone marrow transplantation (BMT) / stem cell transplantation or solid organ transplantation.
- History or diagnoses of other autoimmune disease, including disease associated with lymphopenia, with the exception of stable thyroid or celiac disease.
- History of significant cardiovascular disease (including history of myocardial infarction, angina, use of anti-anginal medicines (e.g., nitroglycerin), or abnormal stress test).
- Vaccination with a live attenuated vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette- Guérin, and smallpox) within 28 days of dosing (Day 0).
- 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.
- 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.
- Women who are pregnant, lactating, or planning on pregnancy during the study.
- Women of child-bearing potential who are unwilling to use a medically acceptable form of contraception until study Week 52. Contraception is required for 14 days prior to randomization. Highly effective contraception methods include: • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. • Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject. • Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception. • Placement of long-acting reversible contraceptives or intrauterine device or intrauterine system. In case of use of oral contraception women should have been stable on the same brand (or generic equivalent) for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential.
- History of and/or suspected intolerance, hypersensitivity, severe reactions, or anaphylaxis to human/humanized monoclonal antibodies or any components of the formulation of siplizumab or its excipients.
- History of significant allergy (e.g., anaphylaxis) to milk or soy proteins.
- History of recent [within 3 Months of Screening (Visit 1)] or ongoing serious 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 (VL) 12 weeks after cessation of therapy) • Positive Interferon Gamma Release Assay (IGRA) TB test, e.g., Quantiferon-TB Gold or Quantiferon-TB Gold Plus tests • Active infection with EBV as defined by EBV viral load ≥ 10,000 copies per 106 PBMCs or ≥ 2,000 copies per mL of whole blood • Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥ 10,000 IU or copies per mL of whole blood or plasma
- Any of the following laboratory abnormalities at Screening (Visit 1). Abnormal screening values may be confirmed by a repeat test prior to randomization: • White blood count (WBC) < 3 x 10^9/L • Absolute Lymphocyte Count (ALC) < 800 cells/µL • Platelet count <150 x 10^9/L • Hemoglobin < 100 g/L • ALT ≥ 2x upper limit of normal (ULN) • AST ≥ 2x ULN
- Current or prior (within 6 months) treatment that is known to alter the natural history of T1D or immunologic status, including high-dose inhaled, extensive topical or systemic glucocorticoids.
- Active participation in an investigational drug trial within the last six weeks prior to screening.
- Current or prior (within 14 days of Visit 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 28 days of Visit 1 MMTT) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.