Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients

Maruho

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: M518101; Drug: Dovonex; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301157

M518101-US01

Details and patient eligibility

About

This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.

Full description

This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Who are able and willing to give signed informed consent
2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
3. Who have less than 20% of body surface area (BSA) afflicted with plaques
4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion criteria

1. Who have a history of allergy to vitamin D3 derivative preparations.
2. Who have a history of relevant drug hypersensitivity.
3. Who have a history of contact dermatitis induced by a topical medicine.
4. Who are pregnant or lactating.
5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
6. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
7. Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
8. Whose serum calcium levels exceed the upper limit of reference range
9. Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.
10. Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
11. Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
12. Who have been treated with topical therapy during the wash-out period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 4 patient groups, including a placebo group

25ug M518101

Experimental group

Treatment:

Drug: M518101

Vehicle

Placebo Comparator group

Treatment:

Drug: placebo

Dovonex

Active Comparator group

Treatment:

Drug: Dovonex

50ug M518101

Experimental group

Treatment:

Drug: M518101