Psoriasis vulgaris MedDRA version: 18.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: AVX001 ointment
Product Code: AVX001
Pharmaceutical Form: Ointment
INN or Proposed INN: Not assigned
Current Sponsor code: AVX001
Concentration unit: % percent
Concentration type: range
Sponsors
Avexxin AS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Stable plaque psoriasis vulgaris 2. Caucasian male patients aged 18 years or more 3. Plaque psoriasis present relatively symmetrically on arms and/or trunk, with disease severity of at least 1 of each of the signs erythema, infiltration and scaliness. 4. Furthermore, a test area within the area present with an index plaque minimum of 3 cm in diameter and with at least 2 of the signs erythema, infiltration and scaliness, in each side. 5. Following the receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out. 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Use of systemic anti-psoriatic agents (including Methotrexate and biological treatments, whether marketed or not) or drugs with a potential effect on plaque psoriasis within 1 month prior to randomisation. 2. Topical therapy with grade I-III glucocorticoids and/or calcipotriol on the targeted plaques within 1 month prior to randomisation 3. PUVA therapy within 28 days and UVB within 14 days prior to randomisation 4. Planned initiation of or changes in dose of concomitant medication that could affect plaque psoriasis during the study (e.g. beta-blockers, antimalarial drugs, lithium) 5. Known or suspected hypersensitivity to components in the investigational drug. 6. Previous exposure to AVX001 7. Current participation in another interventional clinical trial. 8. Significant concurrent, uncontrolled medical condition including, but not limited to, cardiac, infectious, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease as assessed by the investigator 9. Known or suspected hepatitis B or hepatitis C 10. Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening) 11. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency, psychological disorder or other conditions)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate cutaneous tolerability of a newly formulated ointment containing AVX001 in the doses of 3% and 5% with a fall-back dose of 2% comparing to placebo, topically applied at symmetrically affected areas in patients with mild to moderate plaque psoriasis, in a four-week period, with two weeks follow up;Secondary Objective: • Evaluation of safety profile by recording of adverse events (AEs), clinical laboratory values, and vital signs; • To assess efficacy as the impact on the modified Psoriasis Area and Severity Index – modified PASI • Assessing the change in the severity of the disease using Physicians Global Assessment (PGA) score • To assess the efficacy dose responses of AVX001 • To assess a possible systemic accumulation of the drug • To assess Patient Reported Psoriasis-related Pruritus ;Primary end point(s): At end of follow-up period, the rate of patients having experienced local skin reaction adverse events (LSRAE) grade 3 and 4 throughout the study will be calculated at the individual doses and across all doses.;Timepoint(s) of evaluation of this end point: End of follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Ratio of patients experiencing at least 50% improvement of the modified PASI score at end of treatment. 2. Ratio of patients experiencing local skin reaction adverse events (LSRAE) grade 1 and 2 3. Change in PGA score ;Timepoint(s) of evaluation of this end point: End of treatment or end of follow up | — |
Countries
Denmark
Contacts
Public ContactJoris Wilms
KLIFO A/S
Outcome results
None listed