Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03751007 | A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D) | PHASE1 | COMPLETED | 45 | — | — | Oct 24, 2018 | Oct 13, 2021 | Feb 1, 2023 | 18 | United States, Belgium |
Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab
| Arm | Type | Description |
|---|---|---|
| AG019 Cohort 1 - Low Dose/Adults | EXPERIMENTAL | - |
| AG019 Cohort 2 - High Dose/Adults | EXPERIMENTAL | - |
| AG019 Cohort 3 - Low Dose/Adolescents | EXPERIMENTAL | - |
| AG019 Cohort 4 - High Dose/Adolescents | EXPERIMENTAL | - |
| Combination Cohort 1 - Adults | EXPERIMENTAL | - |
| Combination Cohort 2 - Adolescents | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AG019 - Low Dose | BIOLOGICAL | Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose) |
| Teplizumab | DRUG | Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area). |
| Placebo-AG019 | DRUG | Formulated identically to AG019 with the active ingredient removed. |
| Placebo-Teplizumab | DRUG | Formulated identically to teplizumab with the active ingredient removed. |
| AG019 - High Dose | BIOLOGICAL | Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks |
Inclusion Criteria: * Male or non-pregnant, non-lactating females, 18 - 40 years of age (both inclusive) or 12-17 years of age (both inclusive) * Diagnosis of diabetes according to the American Diabetes Association (ADA) recommended criteria * Evidence of auto-antibodies to at least 1 β-cell autoan...