CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
AG019 - Low Dose +5 morebiological
Likely dose
Teplizumab 17mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03751007
NCT03751007Phase 2Completed
CompareCT.gov

A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)

Precigen Actobio T1D, LLC·interventional·Posted Nov 23, 2018·Updated Feb 1, 2023

In Brief

A Phase 2 clinical trial evaluating AG019 - Low Dose, Teplizumab, and 3 other interventions for Diabetes type1. Completed, enrolled 45 participants across 18 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset type 1 diabetes (T1D).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes type1
CountriesBelgium, United States
CollaboratorsIntrexon Actobiotics NV, d/b/a Precigen Actobio

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 23, 2018
Enrollment StartOct 24, 2018
Primary CompletionOct 13, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.6 years ago

Interventions

AG019 - Low Dosebiological

Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)

Teplizumabdrug

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-AG019drug

Formulated identically to AG019 with the active ingredient removed.

Placebo-Teplizumabdrug

Formulated identically to teplizumab with the active ingredient removed.

AG019 - High Dosebiological

Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks

AG019 - High Dosebiological

Solid, orally administered capsule - 6 capsules per day for 8 weeks.