Efficacy Study Comparing Topical M518101 and Vitamin D3 in Adult Psoriasis Patients

Maruho

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: M518101

Study type: Interventional

Funder types: Industry

Identifiers

NCT01989429

M518101-EU04

2013-001632-21 (EudraCT Number)

Details and patient eligibility

About

M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of plaque psoriasis and is being developed as a topical ointment formulation (M518101)

Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis.

Based on the results of previous phase II trials the phase III trial has been designed to evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger population of patients with stable plaque psoriasis.

Enrollment: 788 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged 18 years or older on the day of signing the informed consent form (ICF)
• Psoriasis patients with up to 20% affected body surface area ( BSA) (not including face or scalp)
• Investigator Global Assessment(IGA) of moderate to severe and who are suitable for topical therapy

Exclusion criteria

• Pregnant or lactating females;
• Patients with known allergic reactions, irritations or sensitivity to vitamin D3 derivatives drug hypersensitivity to other components of the investigational products;
• Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) salicylic acid within 14 days of randomization
• Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial
• Patients whose calcium test at screening exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone);
• Patients who have used any study drug (including experimental biologics) and/or participated in any clinical trial within the last 60 days before the day of randomization
• Patients who have been treated with any biologics for their psoriasis within 30 days or 5 half-lives (whichever is longer) of the biologic before the day of randomization the longest documented half-life of the biologic should be used to calculate the 5 half-lives;
• Patients who have been treated with phototherapy (laser, oral steroids, oral retinoid, oral immunosuppressive/immunomodulative drugs, cytostatics, cyclosporine or methotrexate within 30 days of randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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788 participants in 3 patient groups, including a placebo group

Daivonex

Active Comparator group

Description:

topical application

Treatment:

Drug: M518101

vehicle

Placebo Comparator group

Description:

topical application

Treatment:

Drug: M518101

M518101

Experimental group

Description:

topical application

Treatment:

Drug: M518101