MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type… (NCT03624062) | Clinical Trial Compass
CompletedPhase 1
MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes
United States21 participantsStarted 2020-08-31
Plain-language summary
The study is a randomized, double-masked, placebo-controlled, Phase 1 dose-escalation clinical trial. The objective of the trial is to determine if IBC adjuvanted with MAS-1 is safe and will favor tolerogenic pathways to restore immunologic balance and reverse type 1 diabetes (T1D) autoimmunity.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Be between the ages of 18 and 45 years of age who meet the ADA standard T1DM criteria and are positive for at least 1 islet cell autoantibody.
✓. Type 1-diabetes mellitus diagnosed within the previous 2 years at time of screening
✓. Must have stimulated C-peptide levels ≥ 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization
✓. At least one month from last immunization
✓. Must be willing to comply with intensive diabetes management
✓. If participant is female with reproductive potential, she must have a negative pregnancy test and be willing to avoid pregnancy during the treatment period until 2 months after the last study drug administration.
✓. Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration (COVID-19 vaccination is permitted 60 days following initial study drug administration)
✓. Subjects must have HbA1c levels under 9.5 to be enrolled in the study.
Exclusion criteria
✕. Be currently pregnant or lactating, or anticipate getting pregnant during the treatment period until 2 months after the last study drug administration.
✕. Ongoing use of medications known to influence glucose tolerance
✕
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
✕. Any significant diabetes complications such as renal disease (proteinuria or elevated Cr) and diabetic retinopathy
✕. Have a history of malignancies
✕. Be currently using non-insulin pharmaceuticals to affect glycemic control
✕. Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological abnormalities.
✕. Inability or unwillingness to comply with the provisions of this protocol