A Seamless Phase 1b Study to Evaluate Safety, Tolerability and Efficacy of SER-301 in Adult Subjects with Active Mild-to-Moderate Ulcerative Colitis (Part 1)
- Conditions
- lcerative ColitisUlcerative ColitisOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12620000963921
- Lead Sponsor
- PSI CRO Australia Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Documented diagnosis of UC prior to screening endoscopy
Active mild-to-moderate UC as determined by a 3-Component Modified Mayo Score
Minimum disease extent of 15 cm from the anal verge, confirmed at the screening endoscopy
Naïve to UC treatment or with an inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-ASA compounds, corticosteroids or immunomodulators (e.g., 6-MP, AZA, methotrexate)
Exclusion Criteria
Known history of Crohn’s disease
On steroid medication who are unable to have steroids tapered, and be completely off steroids at least 2 weeks prior to screening
Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at least 2 weeks prior to screening
Previously received any investigational or approved biologic therapy
Previously received any investigational or approved non-biologic therapy, except for those specifically listed in the Permitted Concomitant Medications (e.g., stable dose of 6-MP, AZA, methotrexate)
Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 2 months prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method