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

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01987843
• Collaborator: (none)
• Enrollment: 142
• Locations: 52
• Arms: 4
• Duration (Months): 14
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

• Study Type: Interventional
• 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: Sep 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Primary Outcome Measures

1. Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline) [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Dupnitsa		Bulgaria
2	Research Site	Pleven		Bulgaria
3	Research Site	Sofia		Bulgaria
4	Research Site	Tallinn		Estonia
5	Research Site	Tartu		Estonia
6	Research Site	Bavaria		Germany
7	Research Site	Cologne		Germany
8	Research Site	Duesseldorf		Germany
9	Research Site	Essen		Germany
10	Research Site	Gera		Germany
11	Research Site	Hamburg		Germany
12	Research Site	Hanau		Germany
13	Research Site	Hessen		Germany
14	Research Site	Kiel		Germany
15	Research Site	Lubeck		Germany
16	Research Site	Mainz		Germany
17	Research Site	Debrecen		Hungary
18	Research Site	NyÃ-regyháza		Hungary
19	Research Site	Oroshaza		Hungary
20	Research Site	Szeged		Hungary
21	Research Site	Veszprem		Hungary
22	Research Site	Jelgava		Latvia
23	Research Site	Madona		Latvia
24	Research Site	Riga		Latvia
25	Research Site	Ventspils		Latvia
26	Research Site	Bialystok		Poland
27	Research Site	Bydgoszcz		Poland
28	Research Site	Gdansk		Poland
29	Research Site	Katowice		Poland
30	Research Site	Lodzkie		Poland
31	Research Site	Malopolska		Poland
32	Research Site	Olsztyn		Poland
33	Research Site	Sroda Wielkopolska		Poland
34	Research Site	Warszawa		Poland
35	Research Site	woj. Wielkopolskie		Poland
36	Research Site	Wroclaw		Poland
37	Research Site	Chelyabinsk		Russian Federation
38	Research Site	Moscow		Russian Federation
39	Research Site	Saint-Petersburg		Russian Federation
40	Research Site	Saratovskaya		Russian Federation
41	Research Site	Yaroslavl		Russian Federation
42	Research Site	Dnepropetrovsk		Ukraine
43	Research Site	Dniepropetrovsk		Ukraine
44	Research Site	Donetskaya		Ukraine
45	Research Site	Kyiv		Ukraine
46	Research Site	Lugansk		Ukraine
47	Research Site	Lviv		Ukraine
48	Research Site	Odessa		Ukraine
49	Research Site	Simferopol		Ukraine
50	Research Site	Ternopil		Ukraine
51	Research Site	Uzhgorod		Ukraine
52	Research Site	Zaporizhzhya		Ukraine

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01987843
• Other Study ID Numbers: MT-1303-E06
• First Posted: Nov 19, 2013
• Last Update Posted: Dec 18, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Mitsubishi Tanabe Pharma Corporation: Psoriasis; Plaque Psoriasis
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Dec 18, 2014