NCT01987843

Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Phase IIa, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the study are: * To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis. * To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on Psoriasis Area and Severity Index (PASI).

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	MT-1303-Low
DRUG	MT-1303-Middle
DRUG	MT-1303-High
DRUG	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2014-11-01
• First posted: 2013-11-19
• Last updated: 2014-12-18

Locations

52 sites across 8 countries: Bulgaria, Estonia, Germany, Hungary, Latvia, Poland, Russia, Ukraine