NCT07900659Active, not recruiting
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden - TILFLEX Study
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 150 (actual)
- First submitted
- 19 Sept 2025
- Start date
- Feb 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Clin4all
- Diseases
- Psoriasis
- NCT number
- NCT07900659
What you commit to
- Study type: Observational
- Participants enrolled: 150
- From Feb 2025 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with known hypersensitivity to IL-23 inhibitors
- Patients with active HIV, HBV or HCV infection at the time of inclusion
- Patient with a history of untreated latent tuberculosis or active tuberculosis at inclusion
- Patient with any other serious active infection\* present at inclusion that contraindicates anti-IL23 use.
Other
- Patient unable to comply with study requirements (complete study questionnaires)
- Patient who, in the opinion of the investigator, should not participate in the study. This opinion should be documented in the patient's record.
- Vulnerable patient or patient under court protection
- Pregnant or lactating patients at baseline. Patients of childbearing potential will be informed of the need to use effective contraception during treatment\*\*.
Who the study is looking for
- 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
- Disease diagnosis \> 6 months (regardless of severity at diagnosis)
- Body weight ≥ 90kg and/or a high burden of disease (assessed by physician)
- 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.
- Patient 18 years of age or older at the inclusion visit
- French social security affiliation/entitlement
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Dermatologie - CHU Toulouse-Hôpital Larrey Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.