A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.

Official Title
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A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris

Conditions
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Skin and Connective Tissue Diseases

Intervention / Treatment
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* Drug: LP0113 aerosol spray
* Drug: Aerosol spray vehicle
* Drug: LEO 90100 aerosol foam
* Drug: Betamethasone dipropionate aerosol spray
* Drug: Calcipotriol aerosol spray
* Drug: Daivobet® gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent has been obtained Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products. Age 18 years or above Outpatients Female subjects must be of either non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or, child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy. Exclusion Criteria: Female subjects who are breast feeding Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation: Etanercept - within 4 weeks prior to randomisation and during the trial Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial Ustekinumab - within 16 weeks prior to randomisation and during the trial Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer) Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial, Subjects using phototherapy within the following time periods prior to randomisation and during the trial: PUVA: 4 weeks UVB: 2 weeks Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial: Potent or very potent (WHO group III-IV) corticosteroids Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial: WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis) Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LP0113 aerosol spray<br>Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical | Drug: Aerosol spray vehicle<br> <br> Drug: LEO 90100 aerosol foam<br> <br> Drug: Betamethasone dipropionate aerosol spray<br> <br> Drug: Calcipotriol aerosol spray<br> <br> Drug: Daivobet® gel<br> <br> |
| Placebo Comparator: Aerosol spray vehicle<br>No active ingredient, topical | Drug: LP0113 aerosol spray<br> <br> Drug: LEO 90100 aerosol foam<br> <br> Drug: Betamethasone dipropionate aerosol spray<br> <br> Drug: Calcipotriol aerosol spray<br> <br> Drug: Daivobet® gel<br> <br> |
| Active Comparator: LEO 90100 aerosol foam<br>Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical | Drug: LP0113 aerosol spray<br> <br> Drug: Aerosol spray vehicle<br> <br> Drug: Betamethasone dipropionate aerosol spray<br> <br> Drug: Calcipotriol aerosol spray<br> <br> Drug: Daivobet® gel<br> <br> |
| Active Comparator: Betamethasone dipropionate aerosol spray<br>Betamethasone (as dipropionate) 0.5 mg/g, topical | Drug: LP0113 aerosol spray<br> <br> Drug: Aerosol spray vehicle<br> <br> Drug: LEO 90100 aerosol foam<br> <br> Drug: Calcipotriol aerosol spray<br> <br> Drug: Daivobet® gel<br> <br> |
| Active Comparator: Calcipotriol aerosol spray<br>Calcipotriol (as monohydrate) 50 mcg/g, topical | Drug: LP0113 aerosol spray<br> <br> Drug: Aerosol spray vehicle<br> <br> Drug: LEO 90100 aerosol foam<br> <br> Drug: Betamethasone dipropionate aerosol spray<br> <br> Drug: Daivobet® gel<br> <br> |
| Active Comparator: Daivobet® gel<br>Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical | Drug: LP0113 aerosol spray<br> <br> Drug: Aerosol spray vehicle<br> <br> Drug: LEO 90100 aerosol foam<br> <br> Drug: Betamethasone dipropionate aerosol spray<br> <br> Drug: Calcipotriol aerosol spray<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration) |  | End of treatment compared to baseline - 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in single clinical sign score: erythema, scaling, infiltration |  | End of treatment and individual visits compared to baseline - 4 weeks | 
| Absolute Change in Total Clinical Score (TCS) |  | Individual visits compared to baseline - 4 weeks | 
| Absolute change in total skin thickness and echo-poor band thickness |  | End of treatment compared to baseline - 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis