Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT ID: NCT01987843
Last Updated: 2014-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2013-09-30
2014-11-30
Brief Summary
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* 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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MT-1303-Low
MT-1303-Low Dose
MT-1303-Low
MT-1303-Middle
MT-1303-Middle Dose
MT-1303-Middle
MT-1303-High
MT-1303-High Dose
MT-1303-High
Placebo
Placebo
Placebo
Interventions
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MT-1303-Low
MT-1303-Middle
MT-1303-High
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Locations
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Research Site
Dupnitsa, , Bulgaria
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Tallinn, , Estonia
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Tartu, , Estonia
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Bavaria, , Germany
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Cologne, , Germany
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Düsseldorf, , Germany
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Essen, , Germany
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Gera, , Germany
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Hamburg, , Germany
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Hanau, , Germany
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Hessen, , Germany
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Kiel, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Debrecen, , Hungary
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NyÃ-regyháza, , Hungary
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Orosháza, , Hungary
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Szeged, , Hungary
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Veszprém, , Hungary
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Jelgava, , Latvia
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Madona, , Latvia
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Riga, , Latvia
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Ventspils, , Latvia
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Lodzkie, , Poland
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Malopolska, , Poland
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Olsztyn, , Poland
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Środa Wielkopolska, , Poland
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Warsaw, , Poland
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Woj. Wielkopolskie, , Poland
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Wroclaw, , Poland
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Chelyabinsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saratovskaya, , Russia
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Yaroslavl, , Russia
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Dniepropetrovsk, , Ukraine
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Dnipro, , Ukraine
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Donetskaya, , Ukraine
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Kyiv, , Ukraine
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Luhansk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Simferopol, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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MT-1303-E06
Identifier Type: -
Identifier Source: org_study_id