A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis

Study Overview
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Brief Summary
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This study is conducted to assess the efficacy and safety of LEO 90100 when used on the body for the treatment of stable plaque psoriasis in native adult Chinese subjects, compared to Daivobet® ointment.

Detailed Description
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This study is phase 3, randomised, prospective, investigator-blinded, active-controlled, parallel group, multicentre trial to evaluate the efficacy and safety of 4 weeks treatment with LEO 90100 compared with Daivobet® ointment. Eligible participants will be randomised in a 1:1 ratio to either LEO 90100 or Daivobet® ointment treatment. The trial will last for 6 weeks to 10 weeks for each participant, which includes wash out period and treatment period of up to 4 weeks and a safety follow up period of 2 weeks.

Official Title
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A Phase 3, Randomised, Investigator-blind, Active-controlled, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of 4-weeks Treatment With LEO 90100 and Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis

Conditions
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Stable Plaque Psoriasis

Intervention / Treatment
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* Drug: LEO 90100
* Drug: Daivobet® ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese native Aged 18 or over A clinical diagnosis of stable plaque psoriasis for at least 6 months Stable plaque psoriasis on the trunk and/or limbs (excluding psoriasis on the face, scalp, genitals, and skin folds) involving 2-30% of the body surface at Day 1 (Visit 2) of the trial. Having a Physician Global Assessment of at least 'mild' at Day 1 (Visit 2) An mPASI score of at least 2 on the trunk and/or limbs at Day 1 (Visit 2) Women of childbearing potential must use an adequate form of birth control throughout the trial and for at least 8 weeks after last administration of IMP Male subjects with a female partner of childbearing potential must use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) Having a signed and dated informed consent. Exclusion Criteria: Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to treatment assignment (depending on treatment) Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to treatment assignment Psoralen combined with ultraviolet A therapy (PUVA) within 4 weeks prior to treatment assignment Systemic treatment with Apremilast within 4 weeks prior to treatment assignment Ultraviolet B (UVB) therapy within 2 weeks prior to treatment assignment Topical treatment of psoriasis with strong corticosteroids within 2 weeks prior to treatment assignment Topical treatment of psoriasis with traditional Chinese medicine within 2 weeks prior to treatment assignment Treatment with any non-marketed drug substance (any agent which has not yet been made available for clinical use) within 4 weeks/5 half-lives prior to treatment assignment Any other topical treatment that could affect plaque psoriasis within 2 weeks prior to treatment assignment Current diagnosis of guttate, erythrodermic, exfoliative, pustular or unstable psoriasis Patients with any of the following conditions present on any skin area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds Disorders of calcium metabolism Renal insufficiency, hepatic disorders or severe heart disease Cushing's disease or Addison's disease Known or suspected hypersensitivity to any component(s) of the investigational medicinal product (IMP) Current participation in any other interventional clinical trial Previously screened in this trial Participation in another clinical trial within 4 weeks prior to treatment assignment Women who are pregnant, wishing to become pregnant or are breast-feeding Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 90100<br>The subjects will receive LEO 90100 foam once daily for 4 weeks. | Drug: LEO 90100<br>* Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).<br>|
| Active Comparator: Daivobet® ointment<br>The subjects will receive Daivobet® ointment once daily for 4 weeks. | Drug: Daivobet® ointment<br>* Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment of disease severity (PGA) score of 0 (clear) or 1 (almost clear) at Day 29, with at least a 2-point reduction from baseline | The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema. | From baseline to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A decrease in Modified Psoriasis Area and Severity Index of at least 75% (mPASI-75) from baseline to Day 29 | The extent of psoriatic involvement will be recorded for each of the areas (trunk [including the neck] and the limbs [such as arms and legs]; excluding any involvement on face, scalp, genitals and skin folds) using the following scale: 0=no involvement 1=< 10% 2=10%-29% 3=30%-49% 4=50%-69% 5=70%-89% 6=90%-100%. The severity of the psoriatic lesions in each of the areas will be recorded for each of the clinical signs of redness, thickness and scaliness. Each clinical sign is scored on a scale of 0-4, reflecting the average severity of all psoriatic lesions on the given body region. Higher score indicates more severity. The overall mPASI can range from 0 to 64.8. | From baseline to Day 29 | 
| A decrease in mPASI of at least 90% (mPASI-90) from baseline to Day 29 | The extent of psoriatic involvement will be recorded for each of the areas (trunk [including the neck] and the limbs [such as arms and legs]; excluding any involvement on face, scalp, genitals and skin folds) using the following scale: 0=no involvement 1=< 10% 2=10%-29% 3=30%-49% 4=50%-69% 5=70%-89% 6=90%-100%. The severity of the psoriatic lesions in each of the areas will be recorded for each of the clinical signs of redness, thickness and scaliness. Each clinical sign is scored on a scale of 0-4, reflecting the average severity of all psoriatic lesions on the given body region. Higher score indicates more severity. The overall mPASI can range from 0 to 64.8. | From baseline to Day 29 | 
| Number of subjects with treatment-emergent adverse events (TEAEs) |  | From baseline to Day 43 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable plaque psoriasis, Vitamin D analogue, Native Chinese subjects