A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis

Summary

The purpose of this study is to verify the safety and tolerability of AG011 (genetically modified L. lactis that has been engineered to secrete human Interleukin-10), and to determine whether AG011 can successfully treat the symptoms of moderately active Ulcerative Colitis (UC).

Conditions

• Moderately Active Ulcerative Colitis

Interventions

BIOLOGICAL

AG011

Capsules (low, mid or high dose), twice daily for 28 days, combined with Enema (low, mid or high dose respectively), once daily for 28 days.

OTHER

Placebo

Capsules (matching placebo for low, mid or high dose), twice daily for 28 days, combined with Enema (matching placebo for low, mid or high dose respectively), once daily for 28 days.

Sponsors & Collaborators

• ActoGeniX N.V.

  lead INDUSTRY

Principal Investigators

• Bernard Coulie, MD PhD · Chief Medical Officer ActoGeniX NV

• Annegret Van der Aa, PhD · Project Manager ActoGeniX NV

• Severine Vermeire, MD PhD · UZ Leuven, Belgium

• Geert D'Haens, MD PhD · Imelda Bonheiden, Belgium

• Martine De Vos, MD PhD · UZ Gent, Belgium

• Tom Moreels, MD PhD · UZ Antwerpen, Belgium

• Daan Hommes, MD PhD · Leiden University Medical Center

• Erik Hertervig, MD PhD · Lund University Hospital, Sweden

• Curt Tysk, MD PhD · Orebro University Hospital, Sweden

• Robert Lofberg, MD PhD · Karolinska Institutet

• Pierre Paré, MD PhD · Hôpital St-Sacrement Quebec, Canada

• William Barnett, MD PhD · LHSC - University Campus London, Canada

• Brian Bressler, MD PhD · GI Research Institute Vancouver, Canada

• James Gregor, MD PhD · LHSC - South Street Campus London, Canada

• Hillary Steinhart, MD PhD · Mount Sinai Hospital, Canada

• Richmond Sy, MD PhD · Ottawa Hospital General Campus, Canada

• William Depew, MD PhD · Hotel-Dieu Hospital Kingston, Canada

• Donald Daly, MD PhD · Victoria BC, Canada

• Philippe Vergauwe, MD PhD · AZ Groeninge Campus St.-Niklaas Kortrijk, Belgium

• Olivier Dewit, MD PhD · UCL St. Luc Brussels, Belgium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2009-09-30

Completion

2009-09-30

Countries

• Belgium
• Canada
• Netherlands
• Sweden

Study Locations