Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

What Was Tested

In this phase 2 trial, researchers set out to test Teduglutide (GLP-2 analog).

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh.

There are a total of five visits.

Who Took Part

67 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects must have completed participation in the Pilot Active Crohn's Disease Study. Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:. CDAI score greater than 220. Stool samples not required. C-reactive protein levels are not an exclusion criterion.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: subject must continue to meet all exclusion criteria for pilot active crohn's disease study with the following exceptions:; participation in a clinical study of an experimental drug or device within 30 days before signing consent.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Teduglutide (GLP-2 analog) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-03-01 with completion listed for 2005-11-01.

It ran at 24 sites in United States (20) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study (time frame: 12 weeks after start of study).

It also tracked 2 secondary outcomes, for example The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Teduglutide (GLP-2 analog) in 67 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.