A Phase I Study of RO7021610 in Patients with Ulcerative Colitis
Phase 1
Completed
- Conditions
- lcerative colitis
- Registration Number
- JPRN-jRCT2080224649
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
It was suggested that RO7021610 has acceptable safety profile in Japanese UC patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Japanese patients with ulcerative colitis
- Diagnosis of ulcerative colitis established and confirmed at least 3 months prior to screening initiation
- Diagnosis of moderate-to-severe ulcerative colitis (Mayo endoscopic subscore >=2)
- Inadequate response, loss of response, or intolerance to prior treatment for moderate to severe ulcerative colitis
Exclusion Criteria
- Confirmed or suspected diagnosis of colitis other than ulcerative colitis
- Diagnosis of ulcerative proctitis
- Prior and planned surgery for ulcerative colitis
- History of malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method