M-14745-41
Research type
Research Study
Full title
An open-label, randomised, Phase IV study, to assess the efficacy and safety of tildrakizumab in patients with moderate-to-severe chronic plaque psoriasis who are non-responders to dimethyl fumarate therapy.
IRAS ID
262107
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Almirall, S.A.
Eudract number
2019-000817-35
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
Psoriasis is a chronic relapsing/remitting, inflammatory skin disease. Plaque psoriasis (psoriasis vulgaris) is the most common type of psoriasis, characterised by sharply demarcated erythematous and scaly lesions/plaques with a silvery appearance. Psoriasis is associated with an increased risk of developing serious clinical conditions such as inflammatory arthritis (psoriatic arthritis), and cardiovascular and other non-communicable diseases. Likewise, psoriasis causes great physical, emotional and social burden that lead to impairment in health-related quality of life of people with psoriasis.\nClinical experience shows that people with psoriasis differ widely with individual disease expressions and personal perceptions of disease burden and treatment success. Treatments used to control psoriasis also differ with regard to efficacy, degree of toxicity, treatment effort, and cost. Regarding disease severity, for mild psoriasis the first-line treatment is topical agents, either monotherapy or combination therapy. Phototherapy is considered as second-line treatment in mild psoriasis and first-line treatment in moderate-to-severe disease. The first-line treatment in moderate-to-severe psoriasis also include systemic drugs, both non-biologic and biologic.\nThis clinical trial involves two chronic plaque psoriasis treatments, Dimethyl Fumarate (DMF) and tildrakizumab, a monoclonal antibody against IL-23p19 subcutaneously (SC) administered.\nBoth DMF and tildrakizumab are efficacious and well tolerated in the treatment of patients with moderate-to-severe chronic plaque psoriasis. Both have been approved in the EU as systemic treatments for adult patients with moderate-to-severe plaque psoriasis in need of systemic therapy. There is no data available on the efficacy, safety and tolerability of tildrakizumab in patients who are non-responders to DMF.\nThis is a multicentre, randomised, parallel group, open label phase IV clinical study in patients with moderate-to-severe chronic plaque psoriasis. The main aim of the study is to evaluate the efficacy, safety and tolerability of tildrakizumab in patients who are non-responder to DMF at week 16. \nOverall, approximately 250 patients will be enrolled across 33 study centres in Europe; in at least Germany, Netherlands and United Kingdom (UK). \n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0158
Date of REC Opinion
26 Jul 2019
REC opinion
Further Information Favourable Opinion