NCT Number: NCT01987843
Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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).
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Research Site, Dupnitsa, Bulgaria
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
MT-1303-Middle
DrugMT-1303-High
DrugPlacebo
DrugPrimary outcomes
-
Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)
Time frame: 16 weeks
Sponsors and collaborators
Lead sponsor
Tanabe Pharma Corporation
Industry
Registry information
Official study 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
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Nov 19, 2013
- Registry last updated
- Dec 18, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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