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Active Not Recruiting NCT07900659

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

Conditions: Psoriasis, Moderate to Severe Psoriasis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: Clin4all

Location: Service de Dermatologie - CHU Toulouse-Hôpital Larrey Toulouse

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.

Eligibility Criteria

Inclusion Criteria: 1. Patient with a diagnosis of moderate to severe chronic plaque psoriasis documented in the medical record, defined by: PASI ≥ 10 And/or body surface area (BS) affected ≥ 10% And/or DLQI ≥ 10 2. Disease diagnosis \> 6 months (regardless of severity at diagnosis) 3. Body weight ≥ 90kg and/or a high burden of disease (assessed by physician) 4. Indication for treatment with an IL-23 inhibitor. Tildrakizumab 200mg must be the selected anti-IL-23 therapy prior to enrolling the patient in the study. 5. Patient 18 years of age or older at the inclusion visit 6. French social security affiliation/entitlement Exclusion Criteria: 1. Patient unable to comply with study requirements (complete study questionnaires) 2. Patient who, in the opinion of the investigator, should not participate in the study. This opinion should be documented in the patient's record. 3. Patient included in an interventional clinical trial at inclusion. Except in exceptional cases, concurrent participation in an interventional clinical trial will not be possible during the course of the study and must be discussed in advance with the Sponsor. 4. Vulnerable patient or patient under court protection 5. Patients with known hypersensitivity to IL-23 inhibitors 6. Patients with active HIV, HBV or HCV infection at the time of inclusion 7. Patient with a history of untreated latent tuberculosis or active tuberculosis at inclusion 8. Patient with any other serious active infection\* present at inclusion that contraindicates anti-IL23 use. 9. Pregnant or lactating patients at baseline. Patients of childbearing potential will be informed of the need to use effective contraception during treatment\*\*.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07900659). StuddyBuddy aggregates publicly available trial information.