A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recently Diagnosed Type 1 Diabetes Mellitus (T1D)

a study on Diabetes Diabetes Type 1

Summary

for people ages 12-40 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Steve Gitelman

Description

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 who recently developed Type 1 Diabetes Mellitus (T1D).

Official Title

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)

Details

This Phase 1b/2a, multi-center study will be conducted in participants with clinical recent-onset Type 1 Diabetes Mellitus (T1D).

The primary objective of this study is to assess the safety and tolerability of different doses of AG019 alone as well as AG019 in association with teplizumab. The secondary objectives of this study are: to obtain pharmacodynamic (PD) data of AG019 alone as well as AG019 in association with teplizumab; and to determine the potential presence of AG019 in systemic circulation (safety - systemic exposure) and the presence of L. lactis bacteria in fecal excretion (local exposure): Pharmacokinetic (PK) profile.

This study consists of 2 phases:

Phase 1b: this open-label part of the study will investigate the safety and tolerability of 2 different doses of AG019 in 2 age groups (18-40 years of age and 12-17 years of age).

Phase 2a: this randomized, double-blind part of the study will investigate the safety and tolerability of AG019, in association with teplizumab, in 2 age groups (18-40 years of age and 12-17 years of age).

Keywords

Diabetes Mellitus, Type 1 Diabetes Mellitus AG019 - Low Dose Teplizumab AG019 - High Dose AG019 - Low or High Dose

Eligibility

You can join if…

Open to people ages 12-40

  • 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 autoantigen
  • Stimulated C-peptide measured during 4h Mixed Meal tolerance Test (MMTT) > 0.2 nmol/L
  • The first administration of AG019 should occur no later than 150 days post diagnosis of diabetes
  • Body weight ≥ 33kg
  • Written informed consent obtained and documented (participant, parent, guardian as applicable)

You CAN'T join if...

  • Previous history of serious cytokine release syndrome to teplizumab or other humanized anti-CD3 monoclonal antibodies with no or minimal capacity to bind Fc receptors. (Participants enrolled in the second phase of the trial in either Combination Cohort 1 or Combination Cohort 2, only)
  • Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization
  • Participation in another investigational drug trial within 12 weeks prior to the first study drug intake and during participation in this study
  • History of recurrent infections, other autoimmune diseases, cardiac disease, malignancy, or any other (chronic) medical condition which, in the investigator's opinion, could compromise participant safety
  • Documented history of human immunodeficiency virus (HIV), Hepatitis Virus Type C (HCV), Hepatitis Virus Type B (HBV) infection
  • Evidence of active infection with Epstein-Barr Virus (EBV) or cytomegalovirus (CMV)
  • Evidence of active or latent tuberculosis (TB)
  • Administration of anti-CD3 antibody in past year
  • Current therapy with any other anti-diabetic agents other than insulin (MDI, CSII or analogue). Current or planned therapy with experimental (i.e., unapproved) insulin. Patients on therapy for type 2 diabetes (e.g. metformin) should stop their therapy in order to be eligible for study participation.
  • Use of medications known to influence glucose tolerance
  • Daily use of non-steroidal anti-inflammatory agents
  • Compromised GI mucosal integrity or motility, not attributable to T1D (i.e., recent diarrhea, gluten sensitive enteropathy, inflammatory bowel disease, irritable bowel syndrome), or current use of medications known to influence GI motility

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States
  • Coastal Metabolic Research Centre accepting new patients
    Ventura California 93003 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intrexon T1D Partners, LLC
ID
NCT03751007
Phase
Phase 1/2
Study Type
Interventional
Last Updated