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

Phase 3

• Conditions: L40.0; Psoriasis vulgaris

• Registration Number: DRKS00022104
• Lead Sponsor: niversitätsklinikum Essen (AöR)Allgemeine Poliklinik, PsoriasisKlinik für Dermatologie, Venerologie und Allergologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-09
• Study Completion: 2023-11-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Impairment of quality of life caused by the skin disease as measured with the DLQI<br>- Pruritus and skin pain as measured with the Numeric Rating Scale (NRS) and the Visual Analogue Scale (VAS). The assessments will be performed at each visit. The difference between week 0 and 16 is the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
- Severity of skin lesions as measured with the PASI (Psoriasis Area and Severity Index). The assessments will be performed at each visit. The difference between week 0 and 16 is the secondary endpoint.