A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Dose-escalation, Single Centre Study to Assess the Safety and Efficacy of AVX001 when Administered Topically Once Daily in Patients with mild to moderate plaque psoriasis vulgaris in doses of 3% and 5% ointment

Phase 1

• Conditions: Psoriasis vulgaris; MedDRA version: 18.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-004467-20-DK
• Lead Sponsor: Avexxin AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-10
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 26

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified