Ulcerative Colitis
Conditions
Interventions
investigational material(s)
Generic name etc : MLN0002
INN of investigational material :
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investig
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with well-defined ulcerative colitis 2)Patients who agree to use routinely adequate contraception 3)Patients weigh at least 40 kg etc
Exclusion criteria
Exclusion criteria: 1)Patients for whom surgical intervention for their ulcerative colitis is currently required or anticipated 2)Patients with dysplasia or cancer of colon or rectum 3)Patients with symptoms of intestinal stenosis, history of intestinal resection (except for appendectomy) 4)Patients with intestinal diseases other than ulcerative colitis (radiation colitis, ischemic colitis, drug-induced colitis, Crohn's disease, intestinal Behcet disease, lymphoid follicular hyperplasia, etc.) 5)Patients with presence or history of active or latent tuberculosis 6)Female patients who are pregnant or lactating 7)Patients with prior exposure to MLN0002, natalizumab, rituximab, or efalizumab etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of MLN0002, adverse events, vital signs, weight, electrocardiograph findings, laboratory test results, PML (progressive multifocal leukoencephalopathy) assessment, HAHA (human anti-human antibody) assessment, and neutralizing antibody assessment Summary statistics will be calculated by dose ,etc | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent of alpha4beta7 receptor saturation, partial Mayo score Summary statistics will be calculated by dose ,etc | — |
Outcome results
None listed