Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This is a Phase 2, randomized, double-blinded, placebo-controlled 3-arm, multi-center, parallel-group study with an open-label extension (OLE) period. The study includes a Screening Period (of up to 28 days) and a 12-week Double-Blind Period (Day 1 through Day 85) for all subjects. Subjects completi...
This is a Phase 2, randomized, double-blinded, placebo-controlled 3-arm, multi-center, parallel-group study with an open-label extension (OLE) period. The study includes a Screening Period (of up to 28 days) and a 12-week Double-Blind Period (Day 1 through Day 85) for all subjects. Subjects completing the Double-Blind Period through Day 85 will be provided the opportunity to continue in the OLE Period of the study to receive treatment through approximately one year. Subjects who do not participate in the OLE Period will be followed for 84 days in a Safety Follow-up Period.
Tracking Information
- NCT #
- NCT04857112
- Collaborators
- Not Provided
- Investigators
- Study Director: John Lahey Bausch Health Americas, Inc.
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