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

May 24, 2021 updated by: Shire

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Victoria, British Columbia, Canada, V8T 5G4
        • Odyssey Research
    • 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
      • Sarasota, Florida, United States, 34239
        • Visions Clinical Research - Sarasota
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • Atlanta, Georgia, United States, 30329
        • Pinnacle Trials
      • Atlanta, Georgia, United States, 30342-1764
        • 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
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital-Allegheny Ctr for Digestive Diseases
    • Texas
      • Houston, Texas, United States, 77030
        • Methodist Hospital/Baylor University
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Men and women, 18 years of age and older
  2. Signed and dated informed consent to participate before any study-related procedures are performed
  3. Diagnosis of Crohn's disease for at least 6 months that has been documented and confirmed
  4. A Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive
  5. 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.
  6. HCT 30% or greater
  7. WBC 3.5 x 109/L or greater
  8. Platelets 100 x 109/L or greater
  9. Adequate renal function defined as: serum creatinine and BUN 1.5 x ULN or less
  10. 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
  11. Female subjects of childbearing potential must have negative urine pregnancy test results prior to randomization
  12. 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.
  13. 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.

Exclusion Criteria

  1. Nutritionally compromised subjects requiring enteral or parenteral therapy to maintain weight
  2. Body weight less than 40 kg or more than 100 kg
  3. Bowel obstruction or any condition that may predispose to its development, intestinal perforation, or significant gastrointestinal hemorrhage
  4. Current ileostomy or colostomy or extensive external fistulization (more than 3 external fistulae which are expressible with gentle compression)
  5. 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
  6. History of ulcerative colitis within 6 months of screening visit
  7. Cushing's syndrome
  8. Known HIV infection, or symptoms or signs of HIV infection
  9. Acute systemic infection and/or intestinal infection requiring antibiotic therapy at time of screening or baseline
  10. Evidence of chronic hepatitis B or C viral infection
  11. Decompensated liver disease
  12. Clinically significant ECG abnormalities
  13. History of angina or cardiac arrhythmia requiring drug or device intervention or clinically significant congestive heart failure or other clinically significant cardiac disease
  14. History of myocardial infarction within 12 months of screening
  15. History of thromboembolic disease (e.g., phlebitis, pulmonary embolus) or known congenitally or acquired prothrombotic disorder (e.g., protein C deficiency)
  16. 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
  17. Known substance abuse in the previous 2 years
  18. Nursing mothers or pregnant women
  19. Use of native GLP-2, growth hormone, or growth factors within 3 months of signing informed consent
  20. Use of any of the prior or concomitant medications described in section 5.4, except as specified
  21. Known hypersensitivity to any of the active or inactive constituents of ALX-0600

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
placebo solution injected subcutaneously daily into either thigh or abdomen.
Drug: placebo
placebo solution injected subcutaneously
Experimental: teduglutide 0.05
teduglutide 0.05 mg/kg/d injected subcutaneously daily.
Drug: Teduglutide 0.05 dose
0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
Other Names:
  • GATTEX
Experimental: teduglutide 0.1
0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
Drug: teduglutide 0.1 mg dose
0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen
Other Names:
  • GATTEX
Experimental: teduglutide
0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
Drug: ALX-0600
teduglutide
Other Names:
  • GATTEX
Drug: teduglutide 0.05
0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen
Other Names:
  • GATTEX
Drug: teduglutide 0.2 mg
0.2 mg/kg/d subcutaneously injected into thigh or abdomen
Other Names:
  • GATTEX

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
8 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers.
Time Frame: 8 weeks of treatment
8 weeks of treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2003

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL0600-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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