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

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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

Key facts

Study ID

NCT00072839

Run by

Shire

People needed

100

Starts

2003-11-12

Expected to finish

2005-07-28

Last updated by the study team

2021-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Advanced Clinical Therapeutics — Tucson, Arizona, United States
• Rocky Mountain Gastroenterology — Lakewood, Colorado, United States
• Rx Trials — Washington D.C., District of Columbia, United States
• Clinical Trials Management of Boca Raton — Boca Raton, Florida, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Venture Research — North Miami Beach, Florida, United States
• Visions Clinical Research - Sarasota — Sarasota, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Pinnacle Trials — Atlanta, Georgia, United States
• Saint Joseph's Health System — Atlanta, Georgia, United States
• Northwestern University School of Medicine — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Long Island Clinical Research Associates — Great Neck, New York, United States
• Asher Kornbluth, MD, PC — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Allegheny General Hospital-Allegheny Ctr for Digestive Diseases — Pittsburgh, Pennsylvania, United States
• Methodist Hospital/Baylor University — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• McGuire DVAMC — Richmond, Virginia, United States
• Dean Foundation Research Center — Madison, Wisconsin, United States
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• Odyssey Research — Victoria, British Columbia, Canada
• Health Sciences Center — Winnipeg, Manitoba, Canada
• Queen Elizabeth II Health Sciences — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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