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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00072839
First received: November 11, 2003
Last updated: November 10, 2015
Last verified: January 2015
  Purpose
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Condition Intervention Phase
Crohn's Disease
Drug: ALX-0600
Drug: placebo
Drug: teduglutide 0.05
Drug: teduglutide 0.2 mg
Drug: Teduglutide 0.05 dose
Drug: teduglutide 0.1 mg dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2003
Study Completion Date: September 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: GATTEX
Experimental: teduglutide
0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
Drug: ALX-0600
teduglutide
Other Name: GATTEX
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072839

  Show 26 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: David Jacobs, MD NPS Pharma
  More Information

Publications:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00072839     History of Changes
Other Study ID Numbers: CL0600-008-01 
Study First Received: November 11, 2003
Last Updated: November 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 25, 2016