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

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Skin and Connective Tissue Diseases

Treatments: Drug: Daivobet® gel; Drug: Betamethasone dipropionate aerosol spray; Drug: LP0113 aerosol spray; Drug: LEO 90100 aerosol foam; Drug: Calcipotriol aerosol spray; Drug: Aerosol spray vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02416258

2014-004759-30 (EudraCT Number)

LP0113-1123

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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50 participants in 6 patient groups, including a placebo group

LP0113 aerosol spray

Active Comparator group

Description:

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

Treatment:

Drug: Calcipotriol aerosol spray

Drug: LEO 90100 aerosol foam

Drug: Aerosol spray vehicle

Drug: Betamethasone dipropionate aerosol spray

Drug: Daivobet® gel

Aerosol spray vehicle

Placebo Comparator group

Description:

No active ingredient, topical

Treatment:

Drug: Calcipotriol aerosol spray

Drug: LEO 90100 aerosol foam

Drug: LP0113 aerosol spray

Drug: Betamethasone dipropionate aerosol spray

Drug: Daivobet® gel

LEO 90100 aerosol foam

Active Comparator group

Description:

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

Treatment:

Drug: Calcipotriol aerosol spray

Drug: Aerosol spray vehicle

Drug: LP0113 aerosol spray

Drug: Betamethasone dipropionate aerosol spray

Drug: Daivobet® gel

Betamethasone dipropionate aerosol spray

Active Comparator group

Description:

Betamethasone (as dipropionate) 0.5 mg/g, topical

Treatment:

Drug: Calcipotriol aerosol spray

Drug: LEO 90100 aerosol foam

Drug: Aerosol spray vehicle

Drug: LP0113 aerosol spray

Drug: Daivobet® gel

Calcipotriol aerosol spray

Active Comparator group

Description:

Calcipotriol (as monohydrate) 50 mcg/g, topical

Treatment:

Drug: LEO 90100 aerosol foam

Drug: Aerosol spray vehicle

Drug: LP0113 aerosol spray

Drug: Betamethasone dipropionate aerosol spray

Drug: Daivobet® gel

Daivobet® gel

Active Comparator group

Description:

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

Treatment:

Drug: Calcipotriol aerosol spray

Drug: LEO 90100 aerosol foam

Drug: Aerosol spray vehicle

Drug: LP0113 aerosol spray

Drug: Betamethasone dipropionate aerosol spray