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NCT07900659

Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden

Sponsor: Clin4all

View on ClinicalTrials.gov

Summary

Psoriasis is a chronic inflammatory disease that affects 125 million people around the world with major repercussions on physical and emotional quality of life of patients. Many studies confirmed the association between psoriasis and comorbidities as cardio vascular diseases, gastroinstestinal, kidney diseases, cancers, infections or mood disorders. Psoriasis, specially, when it is severe, is associated with highest mortality and a disease burden linked to comorbidities. Understanding this disease burden associated to psoriasis is crucial for an optimal medical care. Tildrakizumab is indicated in treatment of moderate-to-severe plaque psoriasis in adults who need a systemic treatment, also, in case of failure, intolerance or contraindication to a systemic treatment, including Methotrexate. The aim of TILFLEX study is to evaluate the efficacy, safety and flexibility of Tildrakizumab in patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight \> 90Kg. The main objective is to evaluate the efficacy of Tildrakizumab 200mg at week (W)28.

Official title: Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden - TILFLEX Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2025-02-18

Completion Date

2027-04

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

OTHER

Psoriasis clinical assessment

Global evaluation of psoriasis and specific evaluation by areas if applicable

OTHER

Assessment of comorbidities

Medical history of patient and assessment of comorbidities at each visit

OTHER

Quality of life evaluation

DLQI questionnaire at each visit

OTHER

Well-being evaluation

Evaluation by questionnaire WHO-5 (french version) at each visit

OTHER

Treatment compliance

Assessment by a self-adminitreted questionnaire at W28, W52, W76

OTHER

Physical activity assessment

Self-administreted questionnaire at W0 and W76

Locations (1)

Service de Dermatologie - CHU Toulouse-Hôpital Larrey

Toulouse, France