Moderately Active Ulcerative Colitis Clinical Trial
Official title:
A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects With Moderately Active Ulcerative Colitis
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).
The purpose of this study is to verify the safety and tolerability of AG011 and to determine
whether AG011 can successfully treat the symptoms of Ulcerative Colitis (UC). Three
different dosages will be used in reference to a placebo.
AG011 is an experimental medication. It has been developed as potential treatment for
moderately active UC.
AG011 is the clinical formulation of a genetically modified L. lactis that has been
engineered to secrete human Interleukin-10 (hIL-10). By delivering hIL-10 locally at
inflamed tissue in the intestine, it is believed that, compared to hIL-10 given by
injection, the effectiveness may be increased, with fewer adverse effects.
Study medication will be provided in capsule and enema (topical rectal application) forms by
ActoGeniX NV.
Subjects will be entered sequentially into one of three dose groups, starting from the
lowest dose group. Within each of the first two dose groups, 15 subjects will be entered.
Within the highest dose group, 30 subjects will be entered. Within each dose group, subjects
will be randomly assigned in a 2:1 ratio to receive either AG011 or placebo for 28 days.
Timely monitoring of safety data is planned for the study, such that subject enrollment can
continue without interruption for the purpose of data collection between dose groups. Safety
and tolerability will be closely monitored by the Clinical Safety Specialist (CSS) assigned
to the study. The CSS will review adverse events and laboratory safety data and report any
safety concerns to the Sponsor and a Data Safety Monitoring Committee (DSMC).
At least 8 subjects must have safely completed study treatment for 28 days at a specific
dose level, prior to escalation to the next dose group. The DSMC will convene to assess
safety data when 8 subjects have completed study treatment for 28 days at the specific dose
level. The role of the DSMC for the study will be complete when all subjects in the study
have completed study treatment.
For those patients randomized within the active group, UC symptoms could improve. As a
result of the information gathered by this study, the knowledge and understanding of UC
could improve.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment