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

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ClinicalTrials.gov Identifier: NCT01987843
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: MT-1303-Low Drug: MT-1303-Middle Drug: MT-1303-High Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: MT-1303-Low
MT-1303-Low Dose
 Drug: MT-1303-Low
Experimental: MT-1303-Middle
MT-1303-Middle Dose
 Drug: MT-1303-Middle
Experimental: MT-1303-High
MT-1303-High Dose
 Drug: MT-1303-High
Placebo Comparator: Placebo
Placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline) [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987843


Locations
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Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
More Information
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01987843    
Other Study ID Numbers: MT-1303-E06
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Psoriasis
Plaque Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases