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

NCT01987843 | Completed Phase 2 DMC

• 1 other identifier: MT-1303-E06
• Study Type: interventional
• Target: 142
• Locations: 8 countries
• Sites: 52

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).

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)

  16 weeks

Study Arms (4)

MT-1303-Low

EXPERIMENTAL

MT-1303-Low Dose

Drug: MT-1303-Low

MT-1303-Middle

EXPERIMENTAL

MT-1303-Middle Dose

Drug: MT-1303-Middle

MT-1303-High

EXPERIMENTAL

MT-1303-High Dose

Drug: MT-1303-High

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MT-1303-Low DRUG

MT-1303-Low

MT-1303-Middle DRUG

MT-1303-Middle

MT-1303-High DRUG

MT-1303-High

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (52)

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

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MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

PL (11); RU (5); HU (5); LA (4); BU (3); UA (11); DE (11); ES (2)