psoriasis vulgaris MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Sponsors
Avontec GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male, aged between 18 and 75 years - subjects must habe a diagnosis of mild to moderate plaque-type psoriasis (PASI = 2 symmetrical psoriasis lesions on the extremities each of at least 12 cm2 - Written informed consent 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: ? Significant skin diseases (other than plaque-type psoriasis), especially any condition (including atopy and related disorders) or treatment that may interfere with the skin barrier function and/or may have an influence on the immune response ? Significant medical condition or treatment that may have an influence on the immune response (e.g. auto immune diseases) ? Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis ? Screening laboratory values >= Grade 1 (according to WHO Toxicity Criteria by Grade) ? Administration of any biologic within 3 months prior to study entry ? Administration of any other systemic anti-psoriatic drug (such as systemic corticosteroids, ciclosporin, MTX, fumaric acid esters) within 30 days prior to study entry ? Phototherapy (e.g. UVB, PUVA) within 14 days prior to study entry ? Administration of any topical anti-psoriatic drug within 14 days prior to study entry ? Known adverse reactions of any severity or hypersensitivity to any ingredient of 2% AVT-02 UE ointment ? History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases (e.g. multiple sclerosis) ? Blood donation and loss of more than 400 ml 8 weeks prior to inclusion into study ? HIV infection (has to be excluded by laboratory test prior to randomization) ? Other active infectious diseases ? Alcohol abuse (has to be excluded by laboratory test prior to randomization) ? Major surgery 4 weeks prior to inclusion into study ? Vaccination with 6 days prior to enrolment and during the study ? Excessive UV-exposure 4-weeks prior to enrolment and during the conduct of the study ? Subjects with partner of child-bearing potential should use barrier contraception e.g. condoms. The partners of subjects should also use barrier methods of contraception such as condoms, diaphragm, or the cervical cap. ? Subjects who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with the conduct of the trial ? Participation in any other clinical trial within 4 weeks prior or during this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy and safety of two different dosage regimens of 2% AVT-02 UE ointment in subjects with psoriasis vulgaris compared to placebo as assessed by SOS of marker plaques and safety data during a 4 weeks treatment. The primary objectives will be evaluated by an intra-individual comparison within each treatment arm. The treatment arms will be compared in a separate exploratory analysis ;Secondary Objective: The secondary objective is to evaluate the efficacy and tolerability as assessed by PASI, PGA, physician’s and subject’s assessment of tolerability, laboratory parameter, AEs and photo documentation (selected site only) as well as (for a subset of subjects) by immune histological markers in skin biopsies. The secondary objectives will be evaluated by an intra-individual comparison within each treatment arm. The treatment arms will be compared in a separate exploratory analysis. ;Primary end point(s): The primary efficacy endpoint is the SOS50 response rate at week 4 (SOS50 is defined as the proportion of marker plaques in which a >= 50% improvement in SOS from baseline to week 4). | — |
Countries
Germany
Outcome results
None listed