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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: MT-1303-Low; Drug: Placebo; Drug: MT-1303-Middle; Drug: MT-1303-High

• Registration Number: NCT01987843
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-19
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-1303-Low	MT-1303-Low	MT-1303-Low Dose
Placebo	Placebo	Placebo
MT-1303-Middle	MT-1303-Middle	MT-1303-Middle Dose
MT-1303-High	MT-1303-High	MT-1303-High Dose

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)	16 weeks

Trial Locations

Locations (1)

Research Site; 🇺🇦 Zaporizhzhya, Ukraine