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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01987843
First received: November 13, 2013
Last updated: December 16, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Plaque Psoriasis Drug: MT-1303-Low Drug: MT-1303-Middle Drug: MT-1303-High Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

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

Enrollment: 142
Study Start Date: September 2013
Study Completion Date: November 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987843

  Show 52 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01987843     History of Changes
Other Study ID Numbers: MT-1303-E06
Study First Received: November 13, 2013
Last Updated: December 16, 2014

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Psoriasis
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 19, 2017