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Efficacy and safety of LEO 90100 foam in Japanese subjects with psoriasis vulgaris

Efficacy and safety of LEO 90100 foam in Japanese subjects with psoriasis vulgaris

182

Mean for age was 54.2 years in the LEO 90100 group and 54.8 years in the Ointment group. The distributions of sex were: 58 males (66.67%) and 29 females (33.33%) in the LEO 90100 group, and 61 males (64.21%) and 34 females (35.79%) in the Ointment group

Started: 87 subjects in LEO 90100 foam group; 95 in the Dovobet ointment group Completed: 87 subjects in LEO 90100 foam group; 95 in the Dovobet ointment group

0 all-cause mortality and serious adverse events in both treatment groups. For other adverse events, 15/87 subjects (17.2%) subjects in the LEO 90100 group and 19/95 subjects (20.0%) subjects in the Ointment group

No statistically significant difference was found between the LEO 90100 group and Dovobet ointment group for the overall improvement rate for the target lesion at Visit 4 (end of Week 4).

Statistically significant difference was found between the LEO 90100 group and Dovobet ointment group for the overall improvement rate for the target lesion at Visits 2 and 3 (end of Weeks 1 and 2). Statistically significant difference was found between the LEO 90100 group and Dovobet ointment group for the change in the total sign score for the severity of the three clinical signs (thickness, scaliness, redness) from Visit 1 (baseline) to Visit 4 (end of Week 4) for the target lesion.

Yes

De-identified Individual Participant Data can be made available to researchers in a closed environment for a specific period of time.

LEO Pharma K.K.

1-105 Kanda-Jinbocho, Chiyoda-ku, Tokyo, 101-0051, Japan

LEO Pharma K.K.

1-105 Kanda-Jinbocho, Chiyoda-ku, Tokyo, 101-0051, Japan

completed

Jan. 31, 2019

Interventional

A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group,open trial of LEO 90100 foam versus Dovobet ointment in Japanese subjects with psoriasis vulgaris.

treatment purpose

3

1.Japanese subjects aged 20 years or more
2.Clinical diagnosis of psoriasis vulgaris of less than or equal to 30% BSA (excluding any psoriasis on the face, skin folds, genitals)
3.A target psoriasis lesion on the body, of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of redness, thickness and scaliness
4.Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (Visit 1) and must agree to use an adequate method of birth control

1. Use of systemic treatment with an effect on psoriaisis
2. Use of UV therapy on full body or on the target lesion
3. Use of topical treatment on areas to be treated with trial medication
4. Topical treatment on areas other than treated areas with vitamin D
analogues, immunosuppressants or strong/very strong corticosteroids
5. Skin diseases besides psoriasis on the areas to be treated with trial medication.
6. Disorders of calcium metabolism, hypercalcaemia, renal insufficiency, hepatic disorders, heart disease.

Both

psoriasis vulgaris

investigational material(s)
Generic name etc : LEO 90100 foam
INN of investigational material : combination of calcipotriol hydrate plus betamethasone dipropionate
Therapeutic category code : 269 Other agents for epidermis
Dosage and Administration for Investigational material : Apply adequate amount of LEO 90100 foam to the affected area once daily.

control material(s)
Generic name etc : Dovobet ointment
INN of investigational material : combination of calcipotriol hydrate plus betamethasone dipropionate
Therapeutic category code : 269 Other agents for epidermis
Dosage and Administration for Investigational material : Apply adequate amount of Dovobet ointment to the affected area once daily.

efficacy
Primary Objective:To compare the efficacy of LEO 90100 foam with Dovobet ointment in the treatment of psoriasis in Japanese subjects.
Primary Endpoint:The primary endpoint is "overall improvement rate" for the target lesion at Visit 4 (end of Week 4), defined as "substantial resolution" of clinical signs or at least "moderately improved" in the general change in the target lesion.
"Substantial resolution" is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion.

safety
efficacy
Secondary Objectives:To compare the safety of LEO 90100 foam with Dovobet ointment in the treatment of psoriasis in Japanese subjects.
Secondary Endpoints:The "overall improvement rate" for the target lesion at Visits 2 and 3 (end of Weeks 1 and 2).
The change in the total sign score from Visit 1 to Visit 4; total sign score is defined as the sum of the scores from the 3 clinical signs assessing severity in the target lesion.
The change in the sum of the scores (total sign score) for the severity of the three clinical signs (thickness, scaliness, redness) from Visit 1 to the sum of the scores at Visit 4 (end of Week 4) for the target lesion.
The number of adverse events.

Jan. 16, 2019

Jan. 16, 2019