Phase I, Multiple Dose Study of MLN0002 in Patients with Ulcerative Colitis
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-jRCT2080221099
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 12
1)Patients with well-defined ulcerative colitis
2)Patients who agree to use routinely adequate contraception
3)Patients weigh at least 40 kg
etc
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>Summary statistics will be calculated by dose ,etc
- Secondary Outcome Measures
Name Time Method Percent of alpha4beta7 receptor saturation, partial Mayo score<br>Summary statistics will be calculated by dose ,etc