NCT07900659|Active Not Recruiting
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
TILFLEX
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TILFLEX
Sponsor study identifier
Secondary identifiers
OTHER · Id-RCB
observational
150
1 country
1
Study Start
February 18, 2025
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 18, 2025
Actual (reported)September 19, 2025
Actual (reported)October 28, 2026
Actual (reported)April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Specific response to Tildrakizumab at Week28 (W28)
The response will be assessed by PASI absolute (Psoriasis Area and Severity Index), score from 0 to 72
Week 28
Evaluate the maintenance of efficacy of Tildrakizumab
Week 52 and week 76
Impact of treatment on perceived quality of life
Week 0, Week 28, Week 52 and Week 76
Impact of treatment on well-being
Week 0, Week 28, Week 52 and Week 76
To study the safety of Tildrakizumab
Week 28, Week 52 and Week 76
To study and describe contributing elements to disease burden in real-life.
Week 0, Week 28, Week 52 and Week 76
Profile's participants
Week 28, Week 52 and Week 76
Cohort of patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight \> 90Kg.
Global evaluation of psoriasis and specific evaluation by areas if applicable
Medical history of patient and assessment of comorbidities at each visit
Patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight \> 90Kg
Service de Dermatologie - CHU Toulouse-Hôpital Larrey
Toulouse, 31059, France
150 participants (actual enrollment reported by the registry).
First Submitted
September 19, 2025
First Posted
October 28, 2026
Study Start
February 18, 2025
Actual (reported)A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)
DLQI questionnaire at each visit
Evaluation by questionnaire WHO-5 (french version) at each visit
Assessment by a self-adminitreted questionnaire at W28, W52, W76
Contact the study team to confirm eligibility.
Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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