AzTrials
AzTrials

Crohn's DiseasePhase 2NCT00072839

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

A Phase 2 study testing ALX-0600, teduglutide 0.05 and teduglutide 0.2 mg in people with Crohn's Disease, run by Shire at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
ALX-0600, teduglutide 0.05 and teduglutide 0.2 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
26 sitesin 2 countries
Study dates
12 Nov 2003to 28 Jul 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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.
  • HCT 30% or greater
Show all 13Show fewer
  • WBC 3.5 x 109/L or greater
  • Platelets 100 x 109/L or greater
  • Adequate renal function defined as: serum creatinine and BUN 1.5 x ULN or less
  • Adequate hepatic function defined as: ALT/SPGT, AST/SGOT 2.0 x ULN or less; total bilirubin 1.25 x ULN or less, alkaline phosphatase 1.5 x ULN or less
  • Female subjects of childbearing potential must have negative urine pregnancy test results prior to randomization
  • A stool sample must be taken at screening and analyzed by a local laboratory for enteric pathogens, pathogenic ova and parasites, and Clostridium difficile toxin, and reported negative prior to randomization.
  • C-reactive protein value must be 1.0 mg/dL or more, unless there are obvious manifestations of currently active Crohn's disease such as positive observations on endoscopy, other positive indications by laboratory test results, or the subject has had a previous intestinal resection for Crohn's disease.

Who cannot join

  • 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)
  • Expected to require surgical therapy for Crohn's disease or Crohn's disease related complications within 12 weeks of screening. If an abscess is present, it should be drained at least 3 weeks before pre-screening
  • History of ulcerative colitis within 6 months of screening visit
Show all 21Show fewer
  • Cushing's syndrome
  • Known HIV infection, or symptoms or signs of HIV infection
  • Acute systemic infection and/or intestinal infection requiring antibiotic therapy at time of screening or baseline
  • Evidence of chronic hepatitis B or C viral infection
  • Decompensated liver disease
  • Clinically significant ECG abnormalities
  • History of angina or cardiac arrhythmia requiring drug or device intervention or clinically significant congestive heart failure or other clinically significant cardiac disease
  • History of myocardial infarction within 12 months of screening
  • History of thromboembolic disease (e.g., phlebitis, pulmonary embolus) or known congenitally or acquired prothrombotic disorder (e.g., protein C deficiency)
  • History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
  • Known substance abuse in the previous 2 years
  • Nursing mothers or pregnant women
  • Use of native GLP-2, growth hormone, or growth factors within 3 months of signing informed consent
  • Use of any of the prior or concomitant medications described in section 5.4, except as specified
  • Known hypersensitivity to any of the active or inactive constituents of ALX-0600

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States21 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Pinnacle Trials

    Atlanta, Georgia, 30329

  • Saint Joseph's Health System

    Atlanta, Georgia, 30342-1764

  • Clinical Trials Management of Boca Raton

    Boca Raton, Florida, 33486

  • Northwestern University School of Medicine

    Chicago, Illinois, 60619

  • University of Chicago

    Chicago, Illinois, 60637

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Methodist Hospital/Baylor University

    Houston, Texas, 77030

  • Rocky Mountain Gastroenterology

    Lakewood, Colorado, 80401

  • University of Louisville

    Louisville, Kentucky, 40202

  • Dean Foundation Research Center

    Madison, Wisconsin, 53715

  • Asher Kornbluth, MD, PC

    New York, New York, 10128

  • Venture Research

    North Miami Beach, Florida, 33162

  • Allegheny General Hospital-Allegheny Ctr for Digestive Diseases

    Pittsburgh, Pennsylvania, 15212

  • McGuire DVAMC

    Richmond, Virginia, 23249

  • University of Utah

    Salt Lake City, Utah, 84132

  • Visions Clinical Research - Sarasota

    Sarasota, Florida, 34239

  • Advanced Clinical Therapeutics

    Tucson, Arizona, 85712

  • Rx Trials

    Washington D.C., District of Columbia, 20010

Other trials in United States

Canada5 sites

  • Queen Elizabeth II Health Sciences

    Halifax, Nova Scotia, B3H 1V7

  • Life Screening Centres

    Toronto, Ontario, M5S 2A5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1L5

  • Odyssey Research

    Victoria, British Columbia, V8T 5G4

  • Health Sciences Center

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

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

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Read the detailed description

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.

Conditions
Crohn's Disease
Being tested
ALX-0600, placebo, teduglutide 0.05, teduglutide 0.2 mg, Teduglutide 0.05 dose
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALX-0600Drug

    Also called GATTEX

    teduglutide

  • placeboDrug

    placebo solution injected subcutaneously

  • teduglutide 0.05Drug

    Also called GATTEX

    0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen

  • teduglutide 0.2 mgDrug

    Also called GATTEX

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

  • Teduglutide 0.05 doseDrug

    Also called GATTEX

    0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen

  • teduglutide 0.1 mg doseDrug

    Also called GATTEX

    0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen

Study groups in NCT00072839
Study groupRoleWhat they receive
PlaceboPlacebo comparatorplacebo solution injected subcutaneously daily into either thigh or abdomen.
Receives: Drug: placebo
teduglutide 0.05Experimentalteduglutide 0.05 mg/kg/d injected subcutaneously daily.
Receives: Drug: Teduglutide 0.05 dose
teduglutide 0.1Experimental0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
Receives: Drug: teduglutide 0.1 mg dose
teduglutideExperimental0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
Receives: Drug: ALX-0600; Drug: teduglutide 0.05; Drug: teduglutide 0.2 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8.

    Measured: 8 weeks of treatment

Secondary outcomes (1)

  1. The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers.

    Measured: 8 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2003 (estimated)
  2. Study start12 Nov 2003
  3. Primary completion28 Jul 2005
  4. Study completion28 Jul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072839
Sponsor's protocol ID
CL0600-008
Status last verified
May 2021
First submitted
11 Nov 2003
Last updated
25 May 2021
Results posted
No
Data monitoring committee
No

Publications

  • Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010 Jun;16(6):962-73. doi: 10.1002/ibd.21117.

    PubMed 19821509

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALX-0600, teduglutide 0.05 and teduglutide 0.2 mg in people with Crohn's Disease, run by Shire at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8. (time frame: 8 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00072839, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in