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)



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:12 - 40
Updated:3/7/2019
Start Date:October 27, 2018
End Date:June 30, 2020
Contact:Sven Blomme
Email:sblomme@actobio.com
Phone:+32 9 277 11 77

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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)

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).

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).

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 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)

Exclusion Criteria:

- 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)

- 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
We found this trial at
18
sites
Kansas City, Missouri 64108
Principal Investigator: Wayne Moore, MD, PhD
Phone: 816-960-8940
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Principal Investigator: Lee Metchick, MD
Phone: 386-785-2400
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Fernando Ovalle, MD
Phone: 205-934-4112
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: David Baidal, MD
Phone: 305-243-3781
University of Miami A private research university with more than 15,000 students from around the...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Steve Willi, MD
Phone: 215-590-3668
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Henry Rodriguez, MD
Phone: 813-974-2793
University of South Florida The University of South Florida is a high-impact, global research university...
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Aurora, Colorado 80045
Principal Investigator: Peter Gottlieb, MD
Phone: 303-724-7526
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Baltimore, Maryland 21229
Principal Investigator: Barry J Reiner, MD
Phone: 410-646-4009
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Brussels,
Principal Investigator: Bart Keymeulen, MD
Phone: +32 2 477 77 60
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Chattanooga, Tennessee 37403
Principal Investigator: David M Huffman, MD
Phone: 423-265-3561
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Dallas, Texas 75231
Principal Investigator: Stephen Louis Aronoff, MD
Phone: 214-265-2137
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Indianapolis, Indiana 46202
Principal Investigator: Hebatullah Ismail, MB BCh,MSc,PHD
Phone: 1-317-278-7034
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Indianapolis, IN
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Minneapolis, Minnesota 55455
Principal Investigator: Antoinette Moran, MD
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New Haven, Connecticut 06520
Principal Investigator: Kevan Herold, M.D.
Phone: 203-737-4510
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San Francisco, California 94143
Principal Investigator: Steve Gitelman, MD
Phone: 415-502-9089
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Seattle, Washington 98101
Principal Investigator: Carla Greenbaum, MD
Phone: 206-342-6943
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Sioux Falls, South Dakota 57117
Principal Investigator: Kurt Griffin, MD
Phone: 605-328-8741
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Ventura, California 93003
Principal Investigator: Ronald H Chochinov, MD
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