PsoriasisTILFLEXNCT07900659
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
An observational study of Psoriasis and Moderate to Severe Psoriasis, run by Clin4all at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Moderate to Severe Psoriasis
- What is being tested?
- Psoriasis clinical assessment, Assessment of comorbidities and Quality of life evaluation
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight > 90Kg
Who may be able to join
- 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
Who cannot join
- 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.
- 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.
- Vulnerable patient or patient under court protection
- Patients with known hypersensitivity to IL-23 inhibitors
- Patients with active HIV, HBV or HCV infection at the time of inclusion
Show all 9Show fewer
- 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.
- Pregnant or lactating patients at baseline. Patients of childbearing potential will be informed of the need to use effective contraception during treatment**.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Dermatologie - CHU Toulouse-Hôpital Larrey
Toulouse, 31059
About this study
Official title: Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden - TILFLEX Study
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.
Read more
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.
Read the detailed description
Psoriasis is a common chronic inflammatory disease affecting between 2% and 4% of the French population and around 125 million people worldwide 1-3. Psoriasis has a significant impact on physical and emotional quality of life, comparable to that caused by other serious diseases. Epidemiological data, together with basic scientific research into the natural history and biology of psoriasis, have led to the recognition of this disease as a pathology with significant repercussions on health, going beyond skin involvement alone.
Severe psoriasis is associated with an increased risk of mortality, with cardiovascular causes being the most common. Indeed, these patients have an elevated risk of cardiovascular death (HR 1.57; CI95% 1.26-1.96) compared to a population of patients without psoriasis. Further studies are needed to determine whether the increased mortality rate or excess mortality is due to psoriasis itself, treatments, behaviours or other factors.
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 200mg has already shown its long-term efficacy in treatment of psoriasis and safety in clinical trials such as ReSurface 1 and ReSurface 2 and retrospective studies in patients with a high disease burden or body weight ≥ 90 kg. Further prospectives investigations in real-life are required to confirm the efficacy of Tildrakizumab 200mg in patients with psoriasis and high disearse burden (comorbidities, difficult-to-treat locations, severe form of psoriasis, treatment failure…).
- Conditions
- Psoriasis, Moderate to Severe Psoriasis
- Being tested
- Psoriasis clinical assessment, Assessment of comorbidities, Quality of life evaluation, Well-being evaluation, Treatment compliance
- Keywords
- Psoriasis, Comorbidities, Tildrakizumab, Burden disease
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psoriasis clinical assessmentOther
Global evaluation of psoriasis and specific evaluation by areas if applicable
Assessment of comorbiditiesOther
Medical history of patient and assessment of comorbidities at each visit
Quality of life evaluationOther
DLQI questionnaire at each visit
Well-being evaluationOther
Evaluation by questionnaire WHO-5 (french version) at each visit
Treatment complianceOther
Assessment by a self-adminitreted questionnaire at W28, W52, W76
Physical activity assessmentOther
Self-administreted questionnaire at W0 and W76
| Study group | Role | What they receive |
|---|---|---|
| Single group | Cohort of patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight > 90Kg. Receives: Other: Psoriasis clinical assessment; Other: Assessment of comorbidities; Other: Quality of life evaluation; Other: Well-being evaluation; Other: Treatment compliance; Other: Physical activity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 28
Secondary outcomes (4)
Evaluate the maintenance of efficacy of Tildrakizumab
Maintenance of treatment response will be assessed by PASI (Psoriasis Area and Severity Index) absolute at Week 52 and Week 76 according to Tildrakizumab dose (200mg or 100mg).
Measured: Week 52 and week 76
Impact of treatment on perceived quality of life
Changes in the DLQI (Dermatology Life Quality Index) score. Description of each dimension of the DLQI (Dermatology Life Quality Index) score.
The total score ranges from 0 to 30, and each of the 10 questions is scored on a 4 point Likert scale
Measured: Week 0, Week 28, Week 52 and Week 76
Impact of treatment on well-being
Changes in the well-being score assessed by the WHO-5 Well-Being Index, a short, self-reported questionnaire that measures current mental well-being over the past two weeks. Total sum of the 5 items, ranging from 0 (worst quality of life) to 25 (best quality of life).
Measured: Week 0, Week 28, Week 52 and Week 76
To study the safety of Tildrakizumab
Describe the nature and frequency of adverse events throughout follow-up.
Measured: Week 28, Week 52 and Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start18 Feb 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clin4all
- Sponsor type
- Research network
- Collaborators
- Almirall, SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900659
- Sponsor's protocol ID
- 2024-A01344-43
- Other IDs
- 2024-A01344-43
- Acronym
- TILFLEX
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden - TILFLEX Study
- ClinicalTrials.gov ID
- NCT07900659
- Acronym / sponsor ID
- TILFLEX / 2024-A01344-43
- Conditions
- Psoriasis, Moderate to Severe Psoriasis
- Keywords
- Psoriasis, Comorbidities, Tildrakizumab, Burden disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Clin4allResearch network
- Collaborators
- Almirall, SAS
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Psoriasis is a common chronic inflammatory disease affecting between 2% and 4% of the French population and around 125 million people worldwide 1-3. Psoriasis has a significant impact on physical and emotional quality of life, comparable to that caused by other serious diseases. Epidemiological data, together with basic scientific research into the natural history and biology of psoriasis, have led to the recognition of this disease as a pathology with significant repercussions on health, going beyond skin involvement alone.
Severe psoriasis is associated with an increased risk of mortality, with cardiovascular causes being the most common. Indeed, these patients have an elevated risk of cardiovascular death (HR 1.57; CI95% 1.26-1.96) compared to a population of patients without psoriasis. Further studies are needed to determine whether the increased mortality rate or excess mortality is due to psoriasis itself, treatments, behaviours or other factors.
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 200mg has already shown its long-term efficacy in treatment of psoriasis and safety in clinical trials such as ReSurface 1 and ReSurface 2 and retrospective studies in patients with a high disease burden or body weight ≥ 90 kg. Further prospectives investigations in real-life are required to confirm the efficacy of Tildrakizumab 200mg in patients with psoriasis and high disearse burden (comorbidities, difficult-to-treat locations, severe form of psoriasis, treatment failure…).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Other: Psoriasis clinical assessment, Other: Assessment of comorbidities, Other: Quality of life evaluation, Other: Well-being evaluation, Other: Treatment compliance, Other: Physical activity assessmentCohort of patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight > 90Kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight > 90Kg
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- 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.
- Vulnerable patient or patient under court protection
- Patients with known hypersensitivity to IL-23 inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psoriasis clinical assessmentGlobal evaluation of psoriasis and specific evaluation by areas if applicable | Other | Single group |
| Assessment of comorbiditiesMedical history of patient and assessment of comorbidities at each visit | Other | Single group |
| Quality of life evaluationDLQI questionnaire at each visit | Other | Single group |
| Well-being evaluationEvaluation by questionnaire WHO-5 (french version) at each visit | Other | Single group |
| Treatment complianceAssessment by a self-adminitreted questionnaire at W28, W52, W76 | Other | Single group |
| Physical activity assessmentSelf-administreted questionnaire at W0 and W76 | Other | Single group |
Primary outcome
Specific response to Tildrakizumab at Week28 (W28)
Time frame: Week 28
The response will be assessed by PASI absolute (Psoriasis Area and Severity Index), score from 0 to 72
4 secondary outcomes
Evaluate the maintenance of efficacy of Tildrakizumab
Time frame: Week 52 and week 76
Impact of treatment on perceived quality of life
Time frame: Week 0, Week 28, Week 52 and Week 76
Impact of treatment on well-being
Time frame: Week 0, Week 28, Week 52 and Week 76
To study the safety of Tildrakizumab
Time frame: Week 28, Week 52 and Week 76
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Moderate to Severe Psoriasis, run by Clin4all at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific response to Tildrakizumab at Week28 (W28) (time frame: Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.