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Clinical Trial Summary

The purpose of the study was to assess preliminary efficacy, safety, and tolerability of LYS006 in adult patients with mild to moderate ulcerative colitis and to determine if LYS006 has an adequate clinical profile for further development in this indication.


Clinical Trial Description

This was 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 consisted 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 participant including the 4 week screening period was 16 weeks. At the beginning of the treatment period, subjects were randomized to one of the two following treatment groups in 2:1 ratio - LYS006 - matching placebo ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04074590
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 2
Start date February 3, 2020
Completion date November 7, 2022

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