Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn?s Disease - ND

• Conditions: Patients with Moderate to Severe Crohn?s Disease; MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2008-002783-33-IT
• Lead Sponsor: MILLENNIUM PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1060

Inclusion Criteria

1. Age 18 to 80 2. Male or female patient who is voluntarily able to give informed consent 3. Female patients who: Are post-menopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from four weeks before the first dose of study drug through 6 months after the last dose of study drug, OR agree to completely abstain from heterosexual intercourse. Male patients, even if surgically sterilized (ie, status post-vasectomy), who: Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR Agree to completely abstain from heterosexual intercourse. 4. Diagnosis of Crohn?s disease established at least 6 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. Cases of Crohn?s disease established at least 12 months prior to enrollment for which a histopathology report is not available will be considered based on the weight of the evidence supporting the diagnosis and excluding other potential diagnoses, and must be discussed with the sponsor on a case-by-case basis prior to enrollment. 5. Moderately to severely active Crohn?s disease as determined by a CDAI score of 220 to 480 (see Section 15.1) within 7 days prior to the first dose of study drug and 1 of the following: a. CRP level >2.87 mg/L during the screening period OR b. Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 cm in diameter; aphthous ulcerations are not sufficient) consistent with CD within 4 months prior to screening 6. CD involvement of the ileum and/or colon, at a minimum 7. Patients with extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during screening). 8. Patients with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-todate on colorectal cancer surveillance (may be performed during screening)(See protocol pp. 40-41)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General Exclusion Criteria 1. Previous exposure to MLN0002 2. Female patients who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration. 3. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological,endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety 4. Had any surgical procedure requiring general anesthesia within 30 prior to enrollment or is planning to undergo major surgery during the study period 5. Any history of malignancy, except for the following: (a) adequately-treated nonmetastatic basal cell skin cancer; (b) any other type of non-melanoma skin cancer that has been adequately treated and has not recurred for at least 1 year prior to enrollment; and (c) adequately treated in situ cervical cancer that has not recurred for at least 1 year prior to enrollment 6. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease 7. Positive PML subjective symptom checklist prior to the administration of the first dose of study drug 8. Any of the following laboratory abnormalities during the screening period: a. Hemoglobin level <8 g/dL b. WBC count <3 × 109/L c. Lymphocyte count <0.5 × 109/L d. Platelet count <100 × 109/L or >1200 × 109/L e. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN) f. Alkaline phosphatase >3 × ULN g. Serum creatinine >2 × ULN 9. Current or recent history (within one year prior to enrollment) of alcohol dependence or illicit drug use 10. Active psychiatric problems that, in the investigator?s opinion, may interfere with compliance with the study procedures 11. Unable to attend all the study visits or comply with study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified