mild to moderate plaque-type psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Calcipotriol 50 µg/g_Betamethasone 0.5 mg/g
Pharmaceutical Form: Gel
INN or Proposed INN: Calcipotriol monohydrate
CAS Number: 112965-21-6
Other descriptive name: CALCIPOTRIOL MONOHYDRAT
Sponsors
HELM AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent, personally signed and dated by the subject, is obtained prior to any trial-related activities 2. Male or female subjects 18 years of age or older 3. Clinical diagnosis of stable plaque psoriasis of at least 6 months duration (stable meaning neither spontaneously improving nor rapidly deteriorating plaque psoriasis) 4. Subjects with mild to moderate chronic plaque psoriasis (Psoriasis vulgaris) defined by: • up to 20% BSA affected with plaques (corresponding to a total area of approximately 4000 cm2) • PASI =5.0 to =15.0 • category “mild”, “moderate” or “moderate to severe” on IGA scoring at the screening and baseline visits and who are suitable for topical treatment 5. Female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices [IUDs], sexual abstinence in accordance to the preferred life style or vasectomized partner during the 8-week treatment period *Note: Providing that partner is the sole sexual partner of the female trial participant and has received medical assessment of the surgical success. 6. Ability to understand and comply with study procedures and restrictions. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women 2. Clinically relevant history or presence of any disease or any chronic medical condition which is not well controlled (e.g., disorders of calcium metabolism, hypertension, diabetes, etc.) or surgical history which may interfere with the conduct of the trial in the opinion of the investigator 3. Other active skin diseases (e.g., urticaria, atopic dermatitis, etc.), skin infections (bacterial, fungal, parasitic or viral) or skin conditions that might interfere in the opinion of the investigator with treatment and evaluation of psoriasis 4. Acute psoriasis guttata, psoriasis punctata as well as erythrodermic, exfoliative and pustular psoriasis 5. Findings determined in physical examination including vital signs, or clinical laboratory safety tests which are not deemed eligible in the opinion of the investigator 6. Calcium test at V1 (screening) exceeding the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone) 7. History of an allergic reaction or significant sensitivity to constituents of IMP 8. Contraindications according to summary of product characteristics of the originator gel (Daivobet® gel): Viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds in the areas to be treated 9. Use of topical therapies for the treatment of psoriasis including but not limited to: corticosteroids, vitamin D analogs, retinoids, urea, salicylic acid, coal tar and anthralin during the study or having discontinued less than 2 weeks prior to randomisation 10. Phototherapy for the treatment of psoriasis including but not limited to: UV-A, UV-B, sunbaths less than 4 weeks, and PUVA less than 8 weeks prior to randomisation 11. Systemic therapies for the treatment of psoriasis including but not limited to: cyclosporine, retinoids, methotrexate, tacrolimus, azathioprine, salazosulfapyridine, apremilast and glucocorticoids less than 4 weeks prior to randomisation 12. Use of biologic agents for the treatment of psoriasis as follows: Anti-tumor necrosis factor (TNF) drugs: Adalimumab, infliximab, brodalumab, ixekizumab, etanercept: 8 weeks guselkumab, certolizumab pegol, golimumab: 12 weeks Other biologics: Ustekinumab, alefacept, secukinumab: 24 weeks Rituximab: 12 months 13. Treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which are known to provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium) within 8 weeks before first treatment and/or during the trial. Beta-blockers or angiotensin converting enzyme (ACE) inhibitors are allowed if on a stable dose for 3 months before study medication initiation 14. Use of another investigational agent or participation in the treatment phase of a clinical trial within the last 4 weeks prior to first dose or 5 half-life periods 15. Taking of oral vitamin D supplement, except when the subject has been on a stable dose (up to 2,000 international unit [IU] per day allowed) for at least 56 days (8 weeks) before the day of randomisation and plan to continue the dose for the duration of the trial 16. Taking of medicines that affect calcium metabolism (e.g. any oral prescription Vitamin D derivative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that topical treatment with the generic calcipotriol- betamethasone gel is therapeutically equivalent to the originator Daivobet® gel in the treatment of chronic stable, mild to moderate plaque-type psoriasis as determined by the percentage reduction in psoriasis area and severity index (PASI).;Secondary Objective: To demonstrate the superiority of the generic gel to its vehicle;Primary end point(s): Mean % change from baseline in PASI (psoriasis area and severity index) at Week 4/Day 29;Timepoint(s) of evaluation of this end point: Week 4/Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvement (1 or more points change on a 6 point scale) in IGA (investigator’s global assessment) at Week 4/Day 29 - Mean % change from baseline in mPASI (modified psoriasis area and severity index, excluding head and neck) at Week 4/Day 29 and Week 8/Day 56 (will be calculated using values from PASI evaluation) - Mean % change from baseline in PSSI (psoriasis scalp severity index) at Week 4/Day 29 (will be assessed using the same component scoring criteria and the extent (%) as for PASI evaluation);Timepoint(s) of evaluation of this end point: Week 4/Day 29 and Week 8/Day 56 | — |
Countries
Germany
Contacts
Public ContactMedical Affairs Manager
Helm AG
Outcome results
None listed