NCT04074590

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis

A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	LYS006	capsule for oral use
DRUG	Placebo	capsule for oral use

Timeline

• Start date: 2020-02-03
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2019-08-30
• Last updated: 2024-06-20
• Results posted: 2023-11-09

Locations

9 sites across 6 countries: Bulgaria, Czechia, Germany, Poland, Russia, Slovakia

Regulatory

• FDA-regulated drug study