ClinicaliQ Trial Snapshot
- SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes — Recruiting • Phase II • Diabetes / Metabolic • NCT07187531.
- What is being tested: SAB-142, a human anti-thymocyte immunoglobulin, is being evaluated to determine whether it can arrest the progression of Type 1 Diabetes in newly diagnosed patients by modulating the immune response responsible for beta cell destruction.
- Patient eligibility overview: The trial enrolls patients with Stage 3 New Onset Type 1 Diabetes (NOT1D), representing a critical window where pancreatic beta cell function is actively declining but intervention may still preserve remaining insulin production capacity.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).
Eligibility Snapshot
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- Participant and/or appropriate legal guardian must have given written informed consent and/or assent according to local, regional and/or country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Males and females 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old*, inclusive, at the time of randomisation in Part B. 3. Weight ≥16.0 kg at time of randomisation.
- Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization. For participants who were initially misdiagnosed with Type 2 diabetes, time from misdiagnosis with Type 2 diabetes to randomization is 100 days. Note: The date of diagnosis is defined as the date of the first insulin dose or any other glucose lowering medication. An extension of no more than 14 days is permitted if a participant has planned and/or is required to receive a vaccination within 30 days prior to randomisation or is completing the 10 day CGM period.
- Participant has random C-peptide levels of ≥0.2 nmol/L, measured during Screening. One…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.