EUCTR2015-000482-31-HRActive, not recruitingPhase 1
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study
Takeda Development Centre Europe, Ltd.0 sites692 target enrollmentStarted: July 6, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 692
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 Subjects who withdraw early from Study MLN0002SC-3027 or MLN0002SC-3031 must have withdrawn due to treatment failure (ie, as determined by disease worsening or need for rescue medications from Week 14) during the Maintenance Period.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
- •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 demylinating neurodegenerative disease.
- •10. The subject has a positive PML subjective symptom checklist prior to the administration of study drug.
Investigators
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