Influence of psychological factors on the response to therapy with Secukinumab in psoriasis patients on the subjective and objective level - PSOPSYCH

niversitätsklinikum Essen (AöR)Allgemeine Poliklinik, PsoriasisKlinik für Dermatologie, Venerologie und Allergologie0 sites120 target enrollmentJune 9, 2020

ConditionsL40.0 Psoriasis vulgaris

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: L40.0
Sponsor: niversitätsklinikum Essen (AöR)Allgemeine Poliklinik, PsoriasisKlinik für Dermatologie, Venerologie und Allergologie
Enrollment: 120
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 9, 2020

End Date

November 14, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversitätsklinikum Essen (AöR)Allgemeine Poliklinik, PsoriasisKlinik für Dermatologie, Venerologie und Allergologie

Eligibility Criteria

Inclusion Criteria

•(1\) subject has had diagnosis of moderate\-to\-severe chronic plaque psoriasis for at least 6 months; (2\) Psoriasis Area and Severity Index (PASI) \>12 and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater; (3\) patient is a candidate for systemic therapy (this is defined as a patient having moderate\-to\-severe chronic plaque psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy); (4\) women must not be pregnant and if of childbearing potential, must have a negative serum pregnancy test before entering the study; (5\) women of childbearing potential must agree to use a highly effective method of contraception throughout the therapy.

Exclusion Criteria

•(1\) age \<18 years; (2\) forms of psoriasis other than chronic plaque (e.g, pustular, erythrodermic, guttate or drug\-induced) psoriasis; (3\) existing contraindication to therapy with secukinumab according to the summary of product characteristics like history of hypersensitivity to secukinumab or its excipients or to drugs of similar chemical classes or clinically relevant (chronic or acute) infections, e.g. untreated (latent) tuberculosis or HIV infection; (4\) significant medical problems, which in the opinion of the investigator, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving therapy with secukinumab; (5\) history of, respectively active, inflammatory bowel disease (IBD); (6\) administration of live vaccines \<6 weeks before first injection of secukinumab; (7\) 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; (8\) previous exposure to secukinumab; (9\) ongoing use of systemic anti\-psoriatic treatments (concomitant topical treatment is allowed); (10\) history or evidence of ongoing alcohol or drug abuse, within the last six months before start of the study; (11\) subject is lacking capacity to consent.