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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987843
• Other study ID #: MT-1303-E06
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2013
• Last updated: December 16, 2014
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Ministry of HealthEstonia: The State Agency of MedicineGermany: Federal Institute for Drugs and Medical DevicesHungary: Institutional Ethics CommitteeLatvia: State Agency of MedicinesPoland: Ministry of HealthRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have been diagnosed with plaque psoriasis for at least 6 months prior to screening

• Have moderate to severe chronic plaque psoriasis as defined by PASI score = 12 and BSA = 10% at baseline

• In the investigator's opinion is a candidate for systemic therapy

Exclusion Criteria:

• Non-plaque forms of psoriasis (e.g., guttate, erythrodermic or pustular)

• Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate)

• History of any of a list of pre-defined cardiovascular diseases

• History or known presence of any significant infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study.

• Previous exposure to any other S1P receptor modulator

• Receipt of a live vaccine within 28 days prior to randomisation

• Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate

• Clinically significant findings electrocardiogram (ECG) findings.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• MT-1303-Low

• MT-1303-Middle

• MT-1303-High

• Placebo

Locations

Country	Name	City	State
Bulgaria	Research Site	Dupnitsa
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Sofia
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Germany	Research Site	Bavaria
Germany	Research Site	Cologne
Germany	Research Site	Duesseldorf
Germany	Research Site	Essen
Germany	Research Site	Gera
Germany	Research Site	Hamburg
Germany	Research Site	Hanau
Germany	Research Site	Hessen
Germany	Research Site	Kiel
Germany	Research Site	Lubeck
Germany	Research Site	Mainz
Hungary	Research Site	Debrecen
Hungary	Research Site	NyÃ-regyháza
Hungary	Research Site	Oroshaza
Hungary	Research Site	Szeged
Hungary	Research Site	Veszprem
Latvia	Research Site	Jelgava
Latvia	Research Site	Madona
Latvia	Research Site	Riga
Latvia	Research Site	Ventspils
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Lodzkie
Poland	Research Site	Malopolska
Poland	Research Site	Olsztyn
Poland	Research Site	Sroda Wielkopolska
Poland	Research Site	Warszawa
Poland	Research Site	woj. Wielkopolskie
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saratovskaya
Russian Federation	Research Site	Yaroslavl
Ukraine	Research Site	Dnepropetrovsk
Ukraine	Research Site	Dniepropetrovsk
Ukraine	Research Site	Donetskaya
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lugansk
Ukraine	Research Site	Lviv
Ukraine	Research Site	Odessa
Ukraine	Research Site	Simferopol
Ukraine	Research Site	Ternopil
Ukraine	Research Site	Uzhgorod
Ukraine	Research Site	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Bulgaria,  Estonia,  Germany,  Hungary,  Latvia,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)		16 weeks	No