Male and female patients, 18 to 70 years of age, with a diagnosis of chronic plaque psoriasis. MedDRA version: 9.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Product Name: LAS37779
Product Code: LAS37779
Pharmaceutical Form: Cream
Current Sponsor code: LAS 37779
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration numbe
Sponsors
Laboratorios Almirall, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible to be enrolled as subjects in this study: 1. are male or female, 18 to 70 years of age; 2. if female of childbearing potential, use of a highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomy of the partner. In addition these female patients will have to have a negative pregnancy test at screening and agrees to submit to a pregnancy test at the end of study; 3. have clinical diagnosis of chronic plaque psoriasis, characterized at screening visit by: • an Investigator’s Global Assessment of Disease Severity (IGA static) score of 2 (=mild) or 3 (=moderate). • two target lesions, one located in the elbow or knee and the other on trunk or limbs of similar size (minimum size of 2 cm in diameter) and severity with score of at least 2 (=moderate) for induration and 2 (=moderate) for erythema. • at least 2% but no more than 20% of body surface area (BSA) affected by the disease • have lesions in at least two anatomical regions (trunk, legs or arms) 4. are free of any systemic and dermatologic disorders, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events; 5. may read, understand and provide signed informed consent; 6. are willing to follow the study procedures for treatment application and dosing regimen and complete the study. 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: Patients may not be enrolled as subjects in this study who: 1. are females who are pregnant, plan to become pregnant during the study, or are nursing a child; 2. have inverse or palmoplantar psoriasis; acute guttate, erythrodermic, exfoliative or pustular psoriasis; atopic dermatitis, seborrheic dermatitis; or any inflammatory skin disease other than the primary diagnosis of chronic plaque psoriasis; 3. have markedly improving or worsening psoriasis during the wash-out period (e.g. = 1 point in IGA static) or before study entry. 4. have an Investigator’s Global Assessment of Disease Severity (IGA static) score of 4 (=severe) or 5 (=very severe) and/or are eligible for systemic or ultraviolet light therapy at the investigator’s criteria; 5. have lesions with very severe (= 4) scaling 6. are known to be non-responders to topical treatments; 7. are known to be immuno-compromised, to have an auto-immune disorder, or to have a history of non-cured malignancy; 8. have active Hepatitis B or C, or Acquired Immunodeficiency Syndrome (AIDS); 9. have a history of opportunistic infections, including skin infections within 3 months prior to the Baseline Visit; 10. have any unstable concomitant disease or any significant disease, or any gross physical impairment, which may, in the opinion of the investigator, interfere with the performance of the study, or with the interpretation of study outcomes, or place the subject at undue risk; 11. have a clinically significant laboratory test abnormality at the Screening Visit; 12. have QTcB >430 msec (males) or >450 msec (females) or clinically significant ECG abnormalities at the Screening Visit as determined by a general physician or cardiologist; 13. have not undergone a washout period of 2 weeks for topical corticosteroids, retinoids, calcipotriol, coal tar, anthralin, salicylic acid, or any other topical treatment indicated for psoriasis by the time of Baseline Visit; 14. have not undergone a washout period of 4 weeks for any systemic treatment indicated for psoriasis (including corticosteroids and retinoids), any immunosuppressive or cytostatic agent (including methotrexate and cyclosporin), and prolonged sun exposure or ultraviolet light therapy (UVB, PUVA) by the time of Baseline Visit; 15. are using drugs that may worsen psoriasis, such as lithium, beta-adrenergic antagonists, antimalarials and ACE-inhibitors (patients in stable doses without interruption for at least 2 months throughout the study can be included); 16. have received biologics for treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis or any other immune-related disease within 3 months (6 months for alefacept) by the time of Baseline Visit. 17. intend to use other concomitant therapies during the study for the treatment of their psoriasis (emollient creams without specific pharmacologically active components are permitted no more than once per day; keratolytic or tar shampoos for the scalp are allowed) or plan prolonged sun exposure during the study; 18. are using or intend to use any other medication or therapy (radiation, cytostatic, immunosuppressive) which, in the opinion of the investigator, may interfere with the performance of the study, or with the interpretation of study outcomes, or place the subject at undue risk; 19. have a known sensitivity to any constituents of any of the study drugs; 20. have a history of drug abuse or continuous alcohol consumption; 21. have received any investigational treatment(s) w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, safety, and tolerability of LAS37779 1% cream applied twice daily for 8 weeks, compared to 8 weeks of twice daily applications of LAS37779 vehicle cream.;Secondary Objective: • To assess the relative efficacy, safety, and tolerability of LAS37779 1% cream applied twice daily for 8 weeks to calcipotriol 0.005% cream applied twice daily. • To investigate the systemic drug levels of LAS37779 and its main metabolites after single and multiple cutaneous applications of LAS37779 1% cream in psoriasis patients. • To evaluate the cosmetic acceptability of study creams in patients. ;Primary end point(s): Primary efficacy end-point: Change from baseline in the average Total Sign Score (TSS) of two target lesions to the end of treatment (Visit 6 - Day 56). | — |
Countries
Germany
Outcome results
None listed