Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MT-1303-Low
MT-1303-Middle
MT-1303-High
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis, Plaque Psoriasis
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MT-1303-Low
MT-1303-Middle
MT-1303-High
Placebo
Arm Description
MT-1303-Low Dose
MT-1303-Middle Dose
MT-1303-High Dose
Placebo
Outcomes
Primary Outcome Measures
Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)
Secondary Outcome Measures
Full Information
NCT ID
NCT01987843
First Posted
November 13, 2013
Last Updated
December 16, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01987843
Brief Title
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
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Psoriasis, Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MT-1303-Low
Arm Type
Experimental
Arm Description
MT-1303-Low Dose
Arm Title
MT-1303-Middle
Arm Type
Experimental
Arm Description
MT-1303-Middle Dose
Arm Title
MT-1303-High
Arm Type
Experimental
Arm Description
MT-1303-High Dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MT-1303-Low
Intervention Type
Drug
Intervention Name(s)
MT-1303-Middle
Intervention Type
Drug
Intervention Name(s)
MT-1303-High
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Research Site
City
Dupnitsa
Country
Bulgaria
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Tallinn
Country
Estonia
Facility Name
Research Site
City
Tartu
Country
Estonia
Facility Name
Research Site
City
Bavaria
Country
Germany
Facility Name
Research Site
City
Cologne
Country
Germany
Facility Name
Research Site
City
Duesseldorf
Country
Germany
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Gera
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Hanau
Country
Germany
Facility Name
Research Site
City
Hessen
Country
Germany
Facility Name
Research Site
City
Kiel
Country
Germany
Facility Name
Research Site
City
Lubeck
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
NyÃ-regyháza
Country
Hungary
Facility Name
Research Site
City
Oroshaza
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Veszprem
Country
Hungary
Facility Name
Research Site
City
Jelgava
Country
Latvia
Facility Name
Research Site
City
Madona
Country
Latvia
Facility Name
Research Site
City
Riga
Country
Latvia
Facility Name
Research Site
City
Ventspils
Country
Latvia
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Lodzkie
Country
Poland
Facility Name
Research Site
City
Malopolska
Country
Poland
Facility Name
Research Site
City
Olsztyn
Country
Poland
Facility Name
Research Site
City
Sroda Wielkopolska
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
woj. Wielkopolskie
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saratovskaya
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Dniepropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetskaya
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lugansk
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine
Facility Name
Research Site
City
Simferopol
Country
Ukraine
Facility Name
Research Site
City
Ternopil
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
Country
Ukraine
12. IPD Sharing Statement
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Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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