drugset / Trial / NCT04074590

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

NCT04074590 ↗

Phase 2 Terminated 23 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2020-02-03
Primary completion
2022-11-07
Completion
2022-11-07

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision due to strategic considerations”

registry analysis (other test); LYS006 20mg vs Placebo; p = 0.314; Posterior estimate treatment difference -3.29 (90% CI -18.02 to 13.23) NCT04074590 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject LYS006 Unknown — Oral

Indications