An observational study in Psoriasis and Moderate to Severe Psoriasis, sponsored by Clin4all. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Clin4all · Observational
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.
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…).
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 150 is below the median of 199 across 407 observational studies indexed under Psoriasis.
Browse Psoriasis studies →Clin4all is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight > 90Kg
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort of patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight \> 90Kg.
Other: Psoriasis clinical assessment · Other: Assessment of comorbidities · Other: Quality of life evaluation · Other: Well-being evaluation · Other: Treatment compliance · Other: Physical activity assessment
Global evaluation of psoriasis and specific evaluation by areas if applicable
Medical history of patient and assessment of comorbidities at each visit
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
Self-administreted questionnaire at W0 and W76
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
Time frame: Week 28
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).
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: Week 28, Week 52 and Week 76
To study and describe contributing elements to disease burden in real-life.
Assessment of comobidities.
Time frame: Week 0, Week 28, Week 52 and Week 76
Profile's participants
Identify participants profiles according to rapidity of response to treatment, its maintenance throughout follow-up and contributing elements to disease burden identified
Time frame: Week 28, Week 52 and Week 76
Started Feb 2025 (actual). Primary completion is estimated for Apr 2027, 26 months after the start.
Of 92 non-industry observational studies under Psoriasis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 119. This study's planned 26 months is below that.
Counting every sponsor, half of 173 studies reached it within 37 months; a quarter within 23 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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