SMR-3612
Research type
Research Study
Full title
An Open Label, Multi-Centre, 24 Week, Exploratory Study to Assess the Efficacy and Safety of Skilarence® (Dimethyl Fumarate) in Patients with Moderate Plaque Psoriasis
IRAS ID
255707
Contact name
Richard Warren
Contact email
Sponsor organisation
Almirall Ltd
Eudract number
2018-004010-18
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Summary of Research
This is a multi-national (UK, Ireland, Norway and Denmark), open label, multi-centre (24 sites), exploratory study to assess the safety and efficacy of Skilarence® in patients with moderate plaque psoriasis.
Dermatologists are already using Skilarence® as a treatment choice in patients with moderate plaque psoriasis. This study has been designed to support this use by increasing information on the dosing regimen and to provide additional information on the safety and efficacy of Skilarence® in this moderate group. Therefore the primary objective of this study is to assess the efficacy and safety of Skilarence® (Dimethyl Fumarate) in patients with moderate plaque psoriasis.
Eligible patients will be selected according to the trial inclusion and exclusion criteria, and must be able to stop using their current oral or topical treatments for psoriasis and start using Skilarence®.
A screening period (up to 4 weeks) will be followed by treatment of oral Skilarence®, with visits every 4 weeks up to 16 weeks and a final visit at 24 weeks. Blood and urine samples will be collected and analysed as part of the safety assessment along with checking patient’s general health.
It is expected that the patient's participation in the trial will last up to 28 weeks, with the option to continue with treatment with Skilarence® at the end of the trial for up to 2 years.
A total of 150 consenting patients will be included in the main study and will be treated with Skilarence®.
A research sub-study is also proposed where 100 consenting patients prescribed Skilarence® in the main study will have an additional three blood samples collected. A sub-cohort of these consenting patients (10-20) will also have four skin biopsies collected. The main aim of the sub-study is to determine the molecular and cellular phenotype of moderate psoriasis patients in response to treatment with Skilarence®.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0115
Date of REC Opinion
22 May 2019
REC opinion
Further Information Favourable Opinion