Chronic psoriasis vulgaris
Conditions
Interventions
Product Name: AVX001 0.75%
Pharmaceutical Form: Ointment
Other descriptive name: AVX001
Concentration unit: % percent
Concentration type
Sponsors
Avexxin AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a subject in this trial: • men and women aged 18 or older; • subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) with up to three plaque areas sufficient for six treatment fields; • the target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions; • treatment fields should have a comparable psoriatic infiltrate thickness of at least 200 µm; • the physical examination of the skin must be without disease findings other than psoriasis vulgaris unless the investigator considers a finding to be irrelevant to the outcome of the clinical trial; • female volunteers must either be surgically sterile or female volunteers of childbearing potential (hysterectomy or tubal ligation) or agree to use a reliable method of contraception for at least one month prior to Screening visit 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 or vasectomized partner; • male volunteers must either be vasectomized or agree to use condoms during the trial and for 30 days following the treatment phase; • willing and able to follow all the study procedures and complete the whole study; • written informed consent obtained. 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 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Subjects are to be excluded from the trial when one or more of the following conditions are met: • other skin disease noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial; • subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica or pustular psoriasis; • any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid and except for treatment on the face, ears and scalp) in the 4 weeks before first treatment and/or during the trial; • systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate, apremilast in the three months before first treatment and during the trial; • systemic treatment with biological treatments: rituximab within 12 months, ustekinumab, alefacept or secukinumab within six months or adalimumab, infliximab, brodalumab, ixekizumab, guselkumab, golimumab, certolizumab pegol and etanercept within three months before first treatment and during the trial; • UV A or B-therapy within four weeks and PUVA-therapy within eight weeks before first treatment and during the trial; • treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium, beta-blockers or ACE inhibitors unless on a stable dose for 3 months before study medication initiation; • known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products; • known allergic reactions, irritations or sensitivity to the comparator’s active ingredient and/or components; • contraindications according to summary of product characteristics of the active comparators; • evidence of drug or alcohol abuse; • positive pregnancy test or nursing; • blood pressure (BP) >160 mmHg systolic or >90 mmHg diastolic at screening; • history or symptoms of a clinically significant illness in the four weeks before first treatment and during the trial that in the opinion of the investigator may place the subject at risk by trial participation or influence the outcome of the trial; • participation in the treatment phase of another clinical trial within the last four weeks prior to first treatment in this clinical trial; • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent; • close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of sponsor; • subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline and Day 12;Secondary Objective: Not applicable;Primary end point(s): Change from baseline in psoriatic infiltrate thickness on Day 12 (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography) ;Main Objective: Evaluation of antipsoriatic efficacy and safety of AVX001 in topical formulations compared to topically applied comparator formulations and vehicle | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change from baseline in psoriatic infiltrate thickness on Day 8 (assessed by measurement of the thickness of the EPB of the inflammatory infiltrate using 22-MHz sonography) 2) AUC of change from baseline in thickness of the EPB of the inflammatory infiltrate 3) Evaluation of the antipsoriatic efficacy by clinical assessment using a 5-point score ; Timepoint(s) of evaluation of this end point: 1) Day 8 2) Baseline and Day 12 3)Baseline and Day 12 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Manager
bioskin GmbH
Outcome results
None listed