Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
60

Summary

Conditions
Colitis Ulcerative
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a randomized, placebo-controlled, subject and investigator blinded, multicenter, non-confirmatory, parallel group, proof of concept study in patients with mild to moderate ulcerative colitis. This study consists of a screening period of up to 4 weeks, and a 8 week treatment period followed by a 30 day post treatment period safety follow up. The maximum study duration for each such including the 4 week screening period is 16 weeks. At the beginning of the treatment period, subjects will be randomized to one of the two following treatment groups in 2:1 ratio: LYS006 matching placebo Masking: Double (Participant, Investigator)Masking Description: Subject and investigator blinded via randomizationPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

This is a randomized, placebo-controlled, subject and investigator blinded, multicenter, non-confirmatory, parallel group, proof of concept study in patients with mild to moderate ulcerative colitis. This study consists of a screening period of up to 4 weeks, and a 8 week treatment period followed b...

This is a randomized, placebo-controlled, subject and investigator blinded, multicenter, non-confirmatory, parallel group, proof of concept study in patients with mild to moderate ulcerative colitis. This study consists of a screening period of up to 4 weeks, and a 8 week treatment period followed by a 30 day post treatment period safety follow up. The maximum study duration for each such including the 4 week screening period is 16 weeks. At the beginning of the treatment period, subjects will be randomized to one of the two following treatment groups in 2:1 ratio LYS006 matching placebo

Tracking Information

NCT #
NCT04074590
Collaborators
Not Provided
Investigators
Not Provided