A 12-month, randomized, single-blind, placebo-controlled exposure-response study of TCD601 (siplizumab) in new onset type 1 diabetes patients (STRIDE)

Phase 1

Conditions: ew onset type I diabetes
MedDRA version: 21.1Level: PTClassification code: 10067584Term: Type 1 diabetes mellitus Class: 100000004861
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: CTIS2023-506837-31-00

Lead Sponsor: Itb-Med AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 96

Inclusion Criteria

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.

Exclusion Criteria

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 co