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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: MT-1303-High; Drug: Placebo; Drug: MT-1303-Middle; Drug: MT-1303-Low

Study type: Interventional

Funder types: Industry

Identifiers

NCT01987843

MT-1303-E06

Details and patient eligibility

About

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).

Enrollment: 142 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 4 patient groups, including a placebo group

MT-1303-Low

Experimental group

Description:

MT-1303-Low Dose

Treatment:

Drug: MT-1303-Low

MT-1303-Middle

Experimental group

Description:

MT-1303-Middle Dose

Treatment:

Drug: MT-1303-Middle

MT-1303-High

Experimental group

Description:

MT-1303-High Dose

Treatment:

Drug: MT-1303-High

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo