Completed

A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ALX-0600

+ teduglutide 0.05

+ teduglutide 0.2 mg

Drug
Who is being recruted

Crohn Disease+3

+ Digestive System Diseases

+ Gastroenteritis

Over 18 Years
+34 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorShire
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 12, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease
NCT00072839
Principal SponsorShire
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

13 inclusion criteria required to participate
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
Show More Criteria
21 exclusion criteria prevent from participating
Nutritionally compromised subjects requiring enteral or parenteral therapy to maintain weight
Body weight less than 40 kg or more than 100 kg
Bowel obstruction or any condition that may predispose to its development, intestinal perforation, or significant gastrointestinal hemorrhage
Current ileostomy or colostomy or extensive external fistulization (more than 3 external fistulae which are expressible with gentle compression)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen

Group II

Placebo
placebo solution injected subcutaneously daily into either thigh or abdomen.

Group III

Experimental
teduglutide 0.05 mg/kg/d injected subcutaneously daily.

Group IV

Experimental
0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 26 locations

Suspended

Advanced Clinical Therapeutics

Tucson, United StatesOpen Advanced Clinical Therapeutics in Google Maps
Suspended

Rocky Mountain Gastroenterology

Lakewood, United States
Suspended

Rx Trials

Washington D.C., United States
Suspended

Clinical Trials Management of Boca Raton

Boca Raton, United States
Completed26 Study Centers