EO 32731 for the Treatment of Moderate to Severe Psoriasis VulgarisA phase 2a proof of concept study comparing an oral tablet formulation of LEO 32731 with a corresponding placebo tablet in patients with moderate to severe psoriasis vulgaris A multi-centre, prospective, randomized, double-blind, 2-arm, placebo-controlled, parallel-group study with 16 weeks twice times daily oral treatment - LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

EO Pharma A/S0 个研究点目标入组 36 人2016年2月10日

概览

暂无简介。

注册库

who.int

开始日期

2016年2月10日

结束日期

2017年7月6日

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

EO Pharma A/S

•Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis (max. of 4 joints with active arthritis ) for at least 6 months prior to Screening Visit 2 (SV2\).
•Have moderate to severe psoriasis vulgaris at SV2 and Visit 1 as defined by:
•a. Psoriasis Area and Severity Index (PASI) \> 10 and
•b. Covering \> 10% of the body surface area (BSA) and
•c. Disease severity of moderate or worse (PGA \= 3\) according to the Physician´s Global Assessment of disease severity (PGA).
•Candidates of systemic anti\-psoriatic treatment and/or phototherapy.
•Female subjects must be of non\-childbearing potential, i.e. post\-menopausal for at least 1 year, or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or have undergone tubal litigation)
•Male subjects with pregnant partner or with partners of childbearing potential must be willing to use a condom until end of trial, including the 2 weeks follow up period.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•Subjects with therapy resistant psoriasis defined as: Two or more treatment failures due to inadequate efficacy within the past 5 years of the following treatment classes (systemic therapies) administered in adequate dose and duration according to the label or guidelines (local/national). Subjects who stopped systemic treatment for reasons not related to lack of efficacy should not be excluded
•a. Oral systemic therapies including but not limited to methotrexate, cyclosporine, retinoids, corticosteroids, apremilast and fumaric acid
•b. Biological therapies including but not limited to etanercept, secukinumab, adalimumab, infliximab and ustekinumab
•c. Light therapy (PUVA and UVB).
•Previously exposed to apremilast.
•Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1:
•a. Etanercept – 4 weeks
•b. Adalimumab, certolizumab and infliximab – 2 months
•c. Ustekinumab and secukinumab – 4 months.
•Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants, methotrexate, cyclosporine or fumaric acid) within 4 weeks or 5 half\-lives (whichever is longer) prior to Visit 1\.