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

May 12, 2021 updated by: Shire

An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L5
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Center
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences
    • Ontario
      • Toronto, Ontario, Canada, M5S 2A5
        • Life Screening Centres
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Advanced Clinical Therapeutics
    • Colorado
      • Lakewood, Colorado, United States, 80401
        • Rocky Mountain Gastroenterology
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Rx Trials
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Clinical Trials Management of Boca Raton
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida
      • North Miami Beach, Florida, United States, 33162
        • Venture Research
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Pinnacle Trials
      • Atlanta, Georgia, United States, 30342
        • Saint Joseph's Health System
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60619
        • Northwestern University School of Medicine
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates
      • New York, New York, United States, 10128
        • Asher Kornbluth, MD, PC
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Texas
      • Houston, Texas, United States, 77005
        • Atilla Ertan
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Foundation Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
All subjects in the study dosed at 0.1 mg/kg teduglutide
Drug: Teduglutide (ALX-0600)
0.1 mg/kg injected subcutaneously daily
Other Names:
  • teduglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks after start of study

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved.
Time Frame: 12 weeks after study start
12 weeks after study start
The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study
Time Frame: 12 weeks after study start
12 weeks after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 29, 2006

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL0600-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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