Clinical trial NCT01987843: Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dupnitsa
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Bavaria
country: Germany
facility: Research Site
city: Cologne
country: Germany
facility: Research Site
city: Duesseldorf
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Gera
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hanau
country: Germany
facility: Research Site
city: Hessen
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: NyÃ-regyhÃ¡za
country: Hungary
facility: Research Site
city: Oroshaza
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
city: Jelgava
country: Latvia
facility: Research Site
city: Madona
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Ventspils
country: Latvia
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Lodzkie
country: Poland
facility: Research Site
city: Malopolska
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Sroda Wielkopolska
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: woj. Wielkopolskie
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratovskaya
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Dnepropetrovsk
country: Ukraine
facility: Research Site
city: Dniepropetrovsk
country: Ukraine
facility: Research Site
city: Donetskaya
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
Study officials:
References: