Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

What Was Tested

The trial (phase 2) is built around Teduglutide (GLP-2 analog).

It had four arms (groups): Placebo (placebo comparator), teduglutide 0.05 (experimental), teduglutide 0.1 (experimental) and teduglutide (experimental).

Placebo solution injected subcutaneously daily into either thigh or abdomen.

The registry classes the interventions as drug.

More on the Plan

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

There are a total of six visits.

Who Took Part

The registry lists 100 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: Men and women, 18 years of age and older. Signed and dated informed consent to participate before any study-related procedures are performed. Diagnosis of Crohn's disease for at least 6 months that has been documented and confirmed. A Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive. Female subjects who are not surgically sterile or postmenopausal must use medically acceptable methods of birth control during and for 30 days after the treatment period.

The full record lists 13 inclusion and 21 exclusion criteria; among the exclusions: nutritionally compromised subjects requiring enteral or parenteral therapy to maintain weight; body weight less than 40 kg or more than 100 kg; current ileostomy or colostomy or extensive external fistulization (more than 3 external fistulae which are expressible with gentle compression).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Teduglutide (GLP-2 analog) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Teduglutide (GLP-2 analog).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2003-11-12 with completion listed for 2005-07-28.

It ran at 26 sites in United States (21) and Canada (5).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teduglutide (GLP-2 analog) in 100 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.