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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00072839
Recruitment Status : Completed
First Posted : November 13, 2003
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE November 11, 2003
First Posted Date  ICMJE November 13, 2003
Last Update Posted Date November 13, 2015
Study Start Date  ICMJE October 2003
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00072839 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease
Official Title  ICMJE A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease
Brief Summary The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: ALX-0600
    teduglutide
    Other Name: GATTEX
  • Drug: placebo
    placebo solution injected subcutaneously
  • Drug: teduglutide 0.05
    0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen
    Other Name: GATTEX
  • Drug: teduglutide 0.2 mg
    0.2 mg/kg/d subcutaneously injected into thigh or abdomen
    Other Name: GATTEX
  • Drug: Teduglutide 0.05 dose
    0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
    Other Name: GATTEX
  • Drug: teduglutide 0.1 mg dose
    0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen
    Other Name: GATTEX
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    placebo solution injected subcutaneously daily into either thigh or abdomen.
    Intervention: Drug: placebo
  • Experimental: teduglutide 0.05
    teduglutide 0.05 mg/kg/d injected subcutaneously daily.
    Intervention: Drug: Teduglutide 0.05 dose
  • Experimental: teduglutide 0.1
    0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
    Intervention: Drug: teduglutide 0.1 mg dose
  • Experimental: teduglutide
    0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
    Interventions:
    • Drug: ALX-0600
    • Drug: teduglutide 0.05
    • Drug: teduglutide 0.2 mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00072839
Other Study ID Numbers  ICMJE CL0600-008-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Jacobs, MD NPS Pharma
PRS Account Shire
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP