NCT00295165

Who might be able to join this trial:

• You are 18 years old or older
• You have been officially diagnosed with Crohn's disease (confirmed by a camera exam of the gut or an imaging scan) for at least 4 months before starting the study
• Your Crohn's disease is moderately to severely active at the time of screening, based on a standard scoring system (confirm with trial site)
• If you are already taking medication for Crohn's disease, your dose has been stable for at least 4 weeks before starting the study — certain medications are allowed, including some anti-inflammatory tablets, antibiotics, probiotics, or certain rectal treatments (confirm with trial site)
• If you are a woman who could become pregnant, you have a negative pregnancy test within 3 days before starting the study
• If you are sexually active and could become pregnant, you agree to use an effective form of contraception throughout the whole study
• You are able to give yourself injections of the study drug, or you have someone available who can do this for you
• You are willing and able to give written consent to take part

Who may not be able to join:

• You are currently pregnant or breastfeeding
• You have a colostomy or ileostomy (a surgically created opening in your abdomen for waste)
• You urgently need bowel surgery due to serious complications such as bleeding, infection, blockage, or an abscess
• You have had bowel surgery within the 6 months before starting the study
• You have had symptoms of a bowel blockage, or a significant narrowing of the bowel has been found in the last 6 months that has not been surgically treated
• A stool (poo) test has come back positive for certain harmful bacteria, bacterial toxins, or parasites (such as Salmonella, Clostridium difficile, Giardia, or others) (confirm with trial site)
• Your blood test results show certain abnormalities, such as kidney problems, liver problems, low red blood cell levels, or an abnormal white blood cell count (confirm with trial site)
• You are planning to be admitted to hospital as an in-patient at any point during the study
• You have had any type of cancer in the last 5 years, or have had abnormal cell changes in your colon (except for a treated type of minor skin cancer)
• You have ever taken certain specific medications that stimulate white blood cell growth (such as sargramostim, filgrastim, or natalizumab), or have taken certain other medications — including some immune-suppressing drugs, steroids for Crohn's disease, or anti-TNF treatments — within a certain number of weeks before starting the study (confirm with trial site for specific timeframes)
• You have taken part in another clinical trial, or used any experimental drug, within 4 weeks (or longer) before starting the study
• You have been on tube feeding or intravenous nutrition within 4 weeks before starting the study, unless you have been on a stable nutritional supplement for at least 4 weeks and plan to continue it throughout the study (confirm with trial site)
• You have a known allergy to yeast products or to any ingredient in the study drug
• You currently have an active problem with drug or alcohol misuse
• You have another serious health condition unrelated to Crohn's disease, as judged by the study doctor
• You have previously taken part in this study or any other study involving the same study drug

Important: Always verify eligibility with the trial site directly before applying.