Ulcerative Colitis Crohn’s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Takeda Development Centre Europe, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject has previously participated in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Subjects who withdraw early from Study MLN0002SC-3027 or MLN0002SC-3031 must have withdrawn due to treatment failure (ie, as determined by disease worsening or need for rescue medications from Week 14) during the Maintenance Period. 2. Subjects 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-to-date on colorectal cancer surveillance. 3. Subjects 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 of MLN0002SC-3027 or MLN0002SC-3031. 4. May be receiving a therapeutic dose of the following drugs provided that the dose has been stable throughout the qualifying double-blind study: ? Oral 5-ASA compounds. ? Oral corticosteroid therapy (prednisone or equivalent steroid at a dose =30 mg/day, budesonide at a dose =9 mg/day). ? Probiotics (eg, Culturelle, Saccharomyces boulardii). ? Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea. ? Antibiotics used for treatment of IBD (eg, ciprofloxacin, metronidazole). ? Azathioprine or 6-mercaptopurine, provided the subject was receiving this medication during prior participation in Study MLN002SC-3027 or MLN002SC-3031. ? Methotrexate, provided the subject was receiving this medication during prior participation in Study MLN002SC-3031. 5. The subject has previously participated in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Subjects who did not achieve a clinical response at Week 6 and were not randomized into the Maintenance Phase, and achieved a clinical response at Week 14 after receiving a third open-label vedolizumab IV infusion are eligible to participate. 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 659 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: 1. The subject required surgical intervention for UC or CD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, currently requires surgical intervention for UC or CD, or is anticipated to require surgical intervention for IBD during this study. 2. The subject has had previous exposure to approved or investigational anti-integrins (eg, natalizumab, efalizumab, etrolizumab, AMG 181) or anti-MAdCAM1 antibodies or rituximab. 3. The subject has had hypersensitivity to any of the vedolizumab excipients. 4. Any live vaccinations within 30 days prior to vedolizumab SC administration. 5. The subject has developed a chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise subject safety. 6. The subject has withdrawn from Study MLN0002SC-3027 or MLN0002SC-3031due to a study-drug related AE. 7. The subject is unwilling or unable to self-inject, or does not have a caregiver (defined as a legal adult) to inject the study medication. 8. The subject has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrollment. Subjects with remote history of malignancy (eg, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment. 9. The subject has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or demyelinating neurodegenerative disease. 10. The subject has a positive PML subjective symptom checklist prior to the administration of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To obtain data on adverse events of special interest (AESIs; serious infections including opportunistic infection such as PML, liver injury, malignancies, injection site reactions or systemic reactions and hypersensitivity) in UC and CD subjects receiving long-term vedolizumab SC treatment. • To obtain data on maintaining clinical response and clinical remission in UC and CD subjects receiving long-term vedolizumab SC treatment. • To obtain data on patient reported outcomes (PRO) in UC and CD subjects receiving long-term vedolizumab SC treatment. • To obtain data on patient reported outcomes (PROs) including quality of life and work productivity and activity, in UC and CD subjects receiving long-term vedolizumab SC treatment. • To obtain data on time to major UC and CD-related events (hospitalizations, bowel surgeries, and procedures) in UC and CD subjects receiving long-term vedolizumab SC treatment.;Primary end point(s): • Subject-year-adjusted treatment emergent AEs and SAEs during long-term vedolizumab SC treatment.;Timepoint(s) of evaluation of this end point: Collection of AEs will commence from the time that the subject is first administered study medication (Week 0). Routine collection of AEs will continue until 18 weeks post last dose of medication. AE/SAE assessments: QW: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit. Q2W: Weeks 0, 2, 4, 6, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit.;Main Objective: • To obtain data on long term safety and tolerability on vedolizumab SC in subjects with Ulcerative Colitis (UC) or Crohn’s Disease (CD). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Subject-year-adjusted AESIs during long-term vedolizumab SC treatment. • Proportion of subjects with clinical response during long-term vedolizumab SC treatment using partial Mayo scores defined as a reduction in partial Mayo score of =2 points and =25% from Baseline with an accompanying decrease in rectal bleeding score of =1 or absolute rectal bleeding subscore of =1) in UC subjects and Harvey-Bradshaw Index (HBI) scores (defined as a =3-point decreased in HBI score from baseline) in CD subjects (randomized early terminator CD subjects only [defined as randomized CD subjects withdrawn from the parent study between Week 6 and Week 52]). • Proportion of subjects with clinical remission during long-term vedolizumab SC treatment using partial Mayo scores (defined as a partial Mayo score of =2 and no individual subscore >1 point) in UC subjects and HBI scores (defined as a HBI score of =4 points) in CD subjects.;Timepoint(s) of evaluation of this end point: Collection of AEs will commence from the time that the subject is first administered study medication (Week 0). Routine collection of AEs will continue until 18 weeks post last dose of medication. AE/SAE assessments: QW: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit. Q2W: Weeks 0, 2, 4, 6, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit. Disease activity (Mayo/HBI): QW and Q2W: Weeks 0, 4, 8, 16 then every 8 weeks, plus unscheduled and final safety/early termination visit. | — |
Countries
Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Czech Republic, Denmark, Estonia, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactDirector, Clinical Operations
Takeda Development Center Americas, Inc.
Outcome results
None listed