L40.0
Conditions
Interventions
Group 1: Pharmacological control: group 1
(TAU-treatment as usual) 300mg secukinumab (as in clinical routine, with weekly s.c. injections over 5 weeks (weeks 0-4), followed by three monthly injections (weeks 8, 12 and 16).
Group 2: Partial re
acquisition phase lasting 2 weeks with two injections of 300mg secukinumab (weeks 0-1), followed by an experimental phase with alternating injections of placebo and 150mg secukinumab (weeks 2-4, 8, 12
acquisition phase lasting 2 weeks with two injections of 300mg secukinumab (weeks 0-1), followed by an experimental phase with injections of 75mg secukinumab (weeks 2-4, 8, 12 and 16).
Sponsors
Universitätsklinikum Essen (AöR) Allgemeine Poliklinik, Klinik für Dermatologie, Venerologie und Allergologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patient has had a diagnosis of chronic plaque psoriasis with a Psoriasis Area and Severity Index (PASI) >10 - Patient is a candidate for systemic therapy - Women of childbearing potential: no pregnancy; negative serum pregnancy test before entering the study, agreement to use a highly effective method of contraception
Exclusion criteria
Exclusion criteria: - Forms of psoriasis other than chronic plaque psoriasis - Pregnancy or breast feeding - Insufficient ability to communicate in or understand German, dementia or (functional) analphabetism - Lacking capacity to consent to study participation - Existing contraindication to therapy with secukinumab according to the summary of product characteristics (like history of hypersensitivity to secukinumab or its excipients, chronic infections, like untreated (latent) tuberculosis, administration of live vaccines <6 weeks before therapy onset) - Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol - History of, respectively active, inflammatory bowel disease (IBD) - Ongoing use of systemic anti-psoriatic treatments (concomitant topical treatment is allowed) - Previous exposure to secukinumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Symptoms of itch (assessment via visual analogue scale VAS) - Reduction in quality of life due to the skin disease (assessment via the Dermatology Life Quality Index (DLQI)) Measurement takes place at each visit, the comparison from week 0 to week 20 represents the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Severity of psoriasis (assessment via the Psoriasis Area and Severity Index (PASI)). Measurement takes place at each visit, the comparison from week 0 to week 20 represents the primary endpoint. - The supplementary table "study outcomes" provides an overview of additional secondary outcomes, that are collected within the framework of the collaborative research center this project is a part of (SFB TRR 289). | — |
Countries
Germany
Contacts
Public ContactWiebke Sondermann
Universitätsklinikum Essen (AöR) Allgemeine Poliklinik, Klinik für Dermatologie, Venerologie und Allergologie
Outcome results
None listed