Status:
COMPLETED
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease
Lead Sponsor:
Shire
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- 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.
- Exclusion Criteria
- 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
- 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
Exclusion
Key Trial Info
Start Date :
November 12 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00072839
Start Date
November 12 2003
End Date
July 28 2005
Last Update
May 25 2021
Active Locations (26)
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1
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
2
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States, 80401
3
Rx Trials
Washington D.C., District of Columbia, United States, 20010
4
Clinical Trials Management of Boca Raton
Boca Raton, Florida, United States, 33486