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

NCT07900659 · tracked via the Priya Life Science France tracker

Sponsor

Clin4all

Phase

Observational

Started

2025-02-18

Last updated

2026-10-28

Condition(s) studied

PsoriasisModerate to Severe Psoriasis

Investigational drug(s) / intervention(s)

Psoriasis clinical assessmentAssessment of comorbiditiesQuality of life evaluationWell-being evaluationTreatment compliancePhysical activity assessment

Psoriasis clinical assessment: Global evaluation of psoriasis and specific evaluation by areas if applicable

Assessment of comorbidities: Medical history of patient and assessment of comorbidities at each visit

Quality of life evaluation: DLQI questionnaire at each visit

Well-being evaluation: Evaluation by questionnaire WHO-5 (french version) at each visit

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

Physical activity assessment: Self-administreted questionnaire at W0 and W76

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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\*\*.

Primary outcome measure(s)

Specific response to Tildrakizumab at Week28 (W28) — Week 28
The response will be assessed by PASI absolute (Psoriasis Area and Severity Index), score from 0 to 72

Trial sites (1)

Facility	City	Region	Status
Service de Dermatologie - CHU Toulouse-Hôpital Larrey	Toulouse	France

Other trials for the same condition

Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis Active, not recruiting

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments Recruiting

Assessment of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis Recruiting

Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases Recruiting

Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation? Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07900659 on ClinicalTrials.gov ↗ ← All trials in France