LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Psoriasis Vulgaris

Treatments: Drug: Calcipotriene; Drug: Calcipotriol plus betamethasone; Drug: Betamethasone-17,21-dipropionate; Drug: Topical suspension vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01188928

LEO 80185-G23

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).

Enrollment: 1,152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent obtained prior to any trial related activities (including any washout period).
• Aged 18 years or above
• Either sex
• Any race or ethnicity
• Attending a hospital outpatient clinic or the private practice of a board certified dermatologist.
• Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week.
• An investigator's global assessment of disease severity (IGA) of mild or moderate on the body (trunk and/or limbs) at Day 0 (Visit 1).
• A minimum modified Psoriasis Area and Severity Index (PASI) score for extent of 2 in at least one body region (i.e. psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
• Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).
• Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner. The patients must have used the contraceptive method continually for at least 1 month prior to the pregnancy test, and must continue using the contraceptive method for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).
• Able to communicate with the investigator and understand and comply with the requirements of the study.

Exclusion criteria

• 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, alefacept, infliximab - within 2 months prior to randomisation
  • ustekinumab - within 4 months prior to randomisation
  • experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to randomisation

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

• PUVA or Grenz ray therapy within 4 weeks prior to randomisation.

• UVB therapy within 2 weeks prior to randomisation.

• Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to randomisation.

• Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin D analogues within 2 weeks prior to randomisation.

• Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.

• Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors) during the study.

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

• Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds.

• Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

• Known or suspected severe renal insufficiency or severe hepatic disorders.

• Known or suspected hypersensitivity to component(s) of the investigational products.

• Current participation in any other interventional clinical study.

• Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation or longer, if the class of substance required a longer washout as defined above (e.g. biological treatments).

• Planned excessive exposure to the sun during the study that may affect the psoriasis vulgaris.

• Previously randomised in this study.

• Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or are breast-feeding. Females of child-bearing potential wishing to become pregnant during the study, or not using an adequate method of contraception during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,152 participants in 4 patient groups, including a placebo group

LEO 80185

Experimental group

Description:

Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension

Treatment:

Drug: Calcipotriol plus betamethasone

Betamethasone

Active Comparator group

Description:

Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle

Treatment:

Drug: Betamethasone-17,21-dipropionate

Calcipotriol

Active Comparator group

Description:

Calcipotriol 50 mcg/g in the topical suspension vehicle

Treatment:

Drug: Calcipotriene

Topical suspension vehicle

Placebo Comparator group

Description:

The topical suspension vehicle alone

Treatment:

Drug: Topical suspension vehicle