Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

Inclusion Criteria

• In the opinion of the investigator, participants were capable of understanding and complying with protocol requirements
• Participants or, when applicable, participants legally acceptable representative sign and date the informed consent form prior to initiation of any study procedures
• Participants aged 15 to 80 years (inclusive) at the time of consent
• A nonsterilized male participant who has a female partner of child-bearing potential has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug
• A female participant of child-bearing potential (i.e., nonsterilized or whose last regular menses was within previous 2 years) who has a nonsterilized male partner has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug
• Participants with a diagnosis of small-intestinal, large-intestinal, or small-/large-intestinal Crohn's disease (CD) established based on the Revised Diagnostic Criteria for Crohn's disease issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2012) at least 3 months before the start of administration of study drug
• Participants with baseline CDAI score of 220 to 450(inclusive) and meeting at least one of the followings:
• C-reactive protein (CRP) at screening test is above 0.30 mg/dL
• Participants with irregular or semicircular ulcers or multiple aphthae (10 or more) observed over an extensive area of the small or large intestine on endoscopy or imaging test within the 4 months before the start of administration of study drugs
• Participants with longitudinal ulcers or a cobblestone appearance observed in the small or large intestine on endoscopy or imaging test within 4 months before the start of administration of study drugs
• In case of the participants who meet any of the following criteria; participants with ≥ 8-year history of extensive or limited colitis, participants aged ≥ 50 years, or participants with a first-degree family history of colon cancer, those whom the complication of colon cancer or dysplasia was ruled out by total colonoscopy at the start of study drug administration (or the results from total colonoscopy performed within 1 year before giving consent are available)
• Participants meeting the criteria for treatment failure below with at least one of the following agents received within previous 5 year period before giving consent
• Corticosteroids
• Resistance
• Dependence
• Intolerance
• Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)
• Refractory
• Intolerance
• Anti-tumor necrosis factor alpha (TNFα) antibodies
• Inadequate response
• Loss of response
• Intolerance

Exclusion Criteria

• Participants with an evidence of or suspected abdominal abscess
• Participants with a history of subtotal or total colectomy
• Participants who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome
• Participants with ileostomy, colostomy, or internal fistula, or severe intestinal stenosis
• Participants who have a treatment history with natalizumab, efalizumab or rituximab
• Participants who started 5-aminosalicylic acid oral drug or probiotics treatment, antimicrobials to treat Crohn's disease, or 30 mg/day or less of oral corticosteroids within 13 days before initiation of study drug administration. If these drugs were used within 14 days before initiation of study drug administration, the dosage must have been changed or their use discontinued within 13 days before the initiation of study drug administration
• Participants who had received 5-aminosalicylic acid or corticosteroid enemas/suppositories, intravenous corticosteroid injections, or more than 30 mg/day of oral corticosteroids, medications for