Chronic stable plaque psoriasis. MedDRA version: 17.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Calcipotriol-Betamethasone Sandoz
Product Code: Calcipotriol-Betamethasone Sandoz
Pharmaceutical Form: Ointment
INN or Proposed INN: CALCIPOTRIOL MONOHYDRATE
CAS Number: 112965-21-6
Cur
Sponsors
Lek Pharmaceuticals d.d.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1] Male or female patients =18 years of age. [2] Clinical diagnosis of chronic stable (at least 6 months) plaque psoriasis amenable to topical treatment and involving arms and/or legs and/or trunk (but excluding face, scalp, genitals and intertriginous areas). [3] Psoriasis affecting less than 30% of the body surface area (BSA). [4] A modified PASI score of =5 to =15 at baseline (Visit 2). [5] Female patients of childbearing potential must have a negative pregnancy test prior to randomisation and must agree to use an appropriate method of contraception during the study. [6] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled visits, and compliance with protocol requirements as evidenced by providing signed written informed consent. [7] An albumin-corrected serum calcium level below the upper reference range limit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 411 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 411
Exclusion criteria
Exclusion criteria: - History of hypersensitivity or intolerance to any active substance or any of the excipients of the study medication - History of hypersensitivity to Adrenocorticotropic hormone (ACTH), Synacthen® or Synacthen® Depot - Current diagnosis of unstable forms of psoriasis in the area(s) to be treated with study medication, including guttate, erythrodermic, exfoliative, or pustular psoriasis - Other inflammatory skin disease in the area(s) to be treated with study medication that may confound the evaluation of plaque psoriasis - Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the area(s) to be treated with study medication which could interfere with efficacy evaluation - History of psoriasis unresponsive to topical treatments - Viral lesions of the skin - Fungal or bacterial skin infections - Parasitic infections - Skin manifestations in relation to tuberculosis or syphilis - Perioral dermatitis - Atrophic skin, striae atrophicae - Fragility of skin veins - Ichthyosis - Acne vulgaris, acne rosacea, rosacea - Dermal ulcers, wounds - Perianal and genital pruritus - Allergic disorders or susceptibility for allergic reactions - Active infectious diseases - Peptic ulcer - Refractory heart failure - Any of the following conditions, whether known or suspected: endocrine disorders, Cushing’s syndrome, primary adrenocortical insufficiency, diabetes mellitus - Current or past history or signs/symptoms suggestive of a clinically significant abnormality in calcium homeostasis with hypercalcaemia, vitamin D toxicity, severe renal impairment (CRCL 3 times the upper limit of normal) - Use of topical anti-psoriatic therapy within 2 weeks prior to baseline (Visit 2) and during the study - Use of systemic corticosteroids within 3 months prior to baseline (Visit 2) and during the study - Use of other systemic anti-psoriatic therapy, systemic antibiotics, or systemic anti-inflammatory agents within 1 month prior to baseline (Visit 2) and during the study - Use of immunosuppressive drugs or oral retinoids within 2 months prior to baseline (Visit 2) and during the study - Chemotherapy or radiation therapy within 3 months prior to baseline (Visit 2) and during the study - Use of systemic anti-psoriatic biologic therapy within 6 months prior to baseline (Visit 2) and during the study - Psoralen + UVA (PUVA) therapy or UVB therapy within 1 month prior to baseline (Visit 2) and during the study - Use of calcium supplements during the study - More than 400 IU/day of vitamin D or vitamin D analogues during the study - Initiation of or changes in non-anti-psoriatic concomitant medication(s) that could affect psoriasis during the study - Initiation of or changes to concomitant medication that could affect calcium metabolism during the study - Change in sleep pattern within 1 month prior to baseline (Visit 2) and during the study - Initiation of or changes in oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 1 month prior to baseline (Visit 2) and during the study - Use of CYP P450 3A4 inducers within 1 month prior to baseline (Visit 2) and during the study - Use of systemic CYP P450 3A4 inhibitors (e.g. ketoconazole, itraconazole, metronidazole) within 1 month prior to baseline (Visit 2) and during the study - Use of topical CYP P450 3A4 inhibitors (e.g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that topical treatment with the generic calcipotriol-betamethasone ointment formulation is therapeutically equivalent to the originator product Daivobet® ointment in the treatment of chronic stable plaque psoriasis as determined by the percentage reduction in modified Psoriasis Area and Severity Index (PASI).;Secondary Objective: - to demonstrate that topical treatment with the generic calcipotriol-betamethasone ointment formulation is superior to vehicle (company’s ointment formulation) in the treatment of chronic stable plaque psoriasis as determined by the percentage reduction in modified Psoriasis Area and Severity Index (PASI). - to assess the efficacy of the generic calcipotriol-betamethasone ointment formulation in comparison to the originator product Daivobet® and vehicle (company’s ointment formulation) in the treatment of chronic stable plaque psoriasis in terms of improvement in: - Investigator's Psoriasis Global Assessment (IPGA) score; - Body Surface Area (BSA) affected by psoriasis; - Patient’s Psoriasis Global Assessment (PPGA) score. - to assess the safety and local tolerance of the generic calcipotriol-betamethasone ointment formulation in comparison to the originator product Daivobet® and vehicle (company’s ointment formulation).;Primary end point(s): Mean percent change from baseline in modified PASI score at the end of week 4.;Timepoint(s) of evaluation of this end point: After week 4 of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean percent change from baseline in modified PASI score at the end of week 1 and week 2. - Proportion of patients with a reduction in modified PASI score of >75% between baseline and end of week 4 (responder). - Proportion of patients with a reduction in modified PASI score of >50% between baseline and end of week 4. - Mean percent change from baseline in IPGA at the end of week 1, week 2, and week 4. - Mean percent change from baseline in PPGA at the end of week 1, week 2, and week 4. - Proportion of patients with controlled disease (defined as "clear" or "almost clear") in IPGA at the end of week 4. - Proportion of patients with controlled disease (defined as "clear" or "almost clear") in PPGA at the end of week 4. - Mean percent change from baseline in BSA measurement at the end of week 1, week 2, and week 4.;Timepoint(s) of evaluation of this end point: After completion of study and closure of data base. | — |
Countries
Bulgaria, Poland
Contacts
Public ContactNina Habjanic
Lek Pharmaceuticals d.d.
Outcome results
None listed