LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Psoriasis Vulgaris

Treatments: Drug: Gel vehicle; Drug: Aerosol foam vehicle; Drug: LEO 90100 aerosol foam; Drug: Calcipotriol BDP gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02132936

LP0053-1003

Details and patient eligibility

About

The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or above
• Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
• A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs
• A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs.

Exclusion criteria

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

• 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
  • adalimumab, infliximab - within 8 weeks prior to randomisation
  • ustekinumab - within 16 weeks prior to randomisation
  • other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)

• Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to randomisation)

• Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.

• Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation

• Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation

• Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation

• Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation

• Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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504 participants in 4 patient groups, including a placebo group

LEO 90100

Experimental group

Description:

LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks

Treatment:

Drug: LEO 90100 aerosol foam

Aerosol foam vehicle

Placebo Comparator group

Description:

Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks

Treatment:

Drug: Aerosol foam vehicle

Calcipotriol BDP gel

Active Comparator group

Description:

Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks

Treatment:

Drug: Calcipotriol BDP gel

Gel vehicle

Placebo Comparator group

Description:

Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks

Treatment:

Drug: Gel vehicle