Psoriasis PalmarisZODIPSONCT05938361
Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis
An observational study of Psoriasis Palmaris and Psoriasis Genital, run by Clin4all at 1 site in France.
Trial summary
Psoriasis is a chronic inflammatory disease that affects between 2% and 4% of the French population.Some specific localizations are more difficult to manage, such as the scalp, nails, genital region and palmoplantar localizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Palmaris, Psoriasis Genital, Psoriasis of Scalp
- What is being tested?
- Psoriasis clinical assessments, Quality of life evaluation and Satisfaction assessment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 6 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 a diagnosis of moderate to severe chronic plaque psoriasis with specific difficult-to-treat locations.
Who may be able to join
- Patient with a diagnosis of moderate to severe chronic plaque psoriasis documented in the medical record,
- Disease diagnosis > 6 months (regardless of severity at diagnosis)
- Involvement of at least one of the following areas: nails, scalp, genital, palmoplantar (non-pustular)
- Indication for treatment by IL-23 inhibitor. Tildrakizumab must be the selected IL-23 inhibitor therapy prior to enrolling the patient in the study. Patients who have previously received previous treatment by IL-23 inhibitors may be included.
- Patient 18 years of age or older at the inclusion visit
- French social security beneficiary
Who cannot join
- Patient unable to comply with study requirements (i.e.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.
- Vulnerable patient or patient under court protection
- Patients with known hypersensitivity to IL-23 inhibitors
- Patients with HIV or active 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 IL23 inhibitors use.
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis - ZODIPSO Study
Psoriasis is a chronic inflammatory disease that affects between 2% and 4% of the French population.Some specific localizations are more difficult to manage, such as the scalp, nails, genital region and palmoplantar localizations.
Tildrakizumab, an anti-interleukin-23 (IL-23) monoclonal antibody, has demonstrated efficacy and safety in the treatment of patients with moderate to severe psoriasis.
Read more
Real-life data on the efficacy of Tildrakizumab in unselected patients with these difficult-to-treat locations are still limited.
The aim of the ZODIPSO study is to evaluate the efficacy and safety of Tildrakizumab in patients presented difficult to treat locations in psoriasis : nail, scalp, genital and palmoplantar.
The main objective is to assess the overall response and the specific response to Tildrakizumab at these specific areas up to W52.
Read the detailed description
Psoriasis is a chronic inflammatory disease that affects between 2% and 4% of the French population. Some specific localizations are more difficult to manage, such as the scalp, nails, genital region and palmoplantar localizations. They are reported at least once during the course of psoriatic disease in more than 80%, 50%, 60%, 12% of patients, respectively.
Despite recent progress in the management of the disease, these localizations remain a challenge for psoriasis patients because of their impact on quality of life and the difficulty of treating them.
Tildrakizumab, an anti-interleukin-23 (IL-23) monoclonal antibody, has already demonstrated efficacy and safety in the treatment of patients with moderate to severe psoriasis in two international multicenter randomized clinical trials : reSURFACE 1 and reSURFACE 2. However, real-life data on the efficacy of Tildrakizumab in unselected patients with these difficult-to-treat locations are still limited.
- Conditions
- Psoriasis Palmaris, Psoriasis Genital, Psoriasis of Scalp, Psoriasis Plantaris, Psoriasis Nail
- Being tested
- Psoriasis clinical assessments, Quality of life evaluation, Satisfaction assessment, Pruritus evaluation
- Keywords
- Psoriasis, tildrakizumab, difficult-to-treat areas
- 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 assessmentsOther
Global evaluation of psoriasis and specific evaluation by areas
Quality of life evaluationOther
DLQI questionnaire at each visit
Satisfaction assessmentOther
Visual analogic scale at W16, W28, W52
Pruritus evaluationOther
Visual analogic scale at each visit
| Study group | Role | What they receive |
|---|---|---|
| Single group | Cohort of patients with difficult-to-treat psoariasis locations on the nail, scalp, genital and/or palmoplantar area. Receives: Other: Psoriasis clinical assessments; Other: Quality of life evaluation; Other: Satisfaction assessment; Other: Pruritus evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific response to Tildrakizumab at W28
Percentage of response based on specific assessment on target area (75% improvement of the specific score compared to Baseline visit)
Measured: Week 28
Secondary outcomes (6)
Overall response to Tildrakizumab
Percentage of response based on global assessment compared to Baseline visit
Measured: Each visit (Week16-Week 28-Week 52)
Specific response to Tildrakizumab
Percentage of response based on specific assessment by area compared to Baseline Visit
Measured: Week 16, week 28 and week 52
Adverse events
Describe adverse events throughout follow-up
Measured: From baseline visit to Week 52
Evaluation of pruritus under treatment
Variation in visual analogic scale (VAS) value
Measured: Each visit (Baseline,Week 16, Week 28, Week 52)
Evaluation of quality of life under treatement
Dermatology Life Quality Index (DLQI) score compared to Baseline Visit
Measured: Each visit (Baseline, Week16, Week 28, Week 52)
Evaluation of satisfaction under treatement
Variation in visual analogic scale (VAS) value
Measured: Each follow-up visit (Week 16, Week 28, Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Nov 2024
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis PalmarisStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clin4all
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ines ZARAA, MD, Principal investigator, Saint Joseph hospital Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938361
- Sponsor's protocol ID
- 2022-A02735-38
- Acronym
- ZODIPSO
- Status last verified
- Oct 2026
- First submitted
- 30 May 2023
- 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 of Tildrakizumab in Difficult-to-treat Areas in Psoriasis - ZODIPSO Study
- ClinicalTrials.gov ID
- NCT05938361
- Acronym / sponsor ID
- ZODIPSO / 2022-A02735-38
- Conditions
- Psoriasis Palmaris, Psoriasis Genital, Psoriasis of Scalp, Psoriasis Plantaris, Psoriasis Nail
- Keywords
- Psoriasis, tildrakizumab, difficult-to-treat areas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Clin4allResearch network
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 10 Jul 2023 (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 between 2% and 4% of the French population.Some specific localizations are more difficult to manage, such as the scalp, nails, genital region and palmoplantar localizations.
Tildrakizumab, an anti-interleukin-23 (IL-23) monoclonal antibody, has demonstrated efficacy and safety in the treatment of patients with moderate to severe psoriasis.
Real-life data on the efficacy of Tildrakizumab in unselected patients with these difficult-to-treat locations are still limited.
The aim of the ZODIPSO study is to evaluate the efficacy and safety of Tildrakizumab in patients presented difficult to treat locations in psoriasis : nail, scalp, genital and palmoplantar.
The main objective is to assess the overall response and the specific response to Tildrakizumab at these specific areas up to W52.
Detailed description
Psoriasis is a chronic inflammatory disease that affects between 2% and 4% of the French population. Some specific localizations are more difficult to manage, such as the scalp, nails, genital region and palmoplantar localizations. They are reported at least once during the course of psoriatic disease in more than 80%, 50%, 60%, 12% of patients, respectively.
Despite recent progress in the management of the disease, these localizations remain a challenge for psoriasis patients because of their impact on quality of life and the difficulty of treating them.
Tildrakizumab, an anti-interleukin-23 (IL-23) monoclonal antibody, has already demonstrated efficacy and safety in the treatment of patients with moderate to severe psoriasis in two international multicenter randomized clinical trials : reSURFACE 1 and reSURFACE 2. However, real-life data on the efficacy of Tildrakizumab in unselected patients with these difficult-to-treat locations are still limited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Other: Psoriasis clinical assessments, Other: Quality of life evaluation, Other: Satisfaction assessment, Other: Pruritus evaluationCohort of patients with difficult-to-treat psoariasis locations on the nail, scalp, genital and/or palmoplantar area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of moderate to severe chronic plaque psoriasis with specific difficult-to-treat locations.
Key inclusion criteria (6 listed)
- Patient with a diagnosis of moderate to severe chronic plaque psoriasis documented in the medical record,
- Disease diagnosis > 6 months (regardless of severity at diagnosis)
- Involvement of at least one of the following areas: nails, scalp, genital, palmoplantar (non-pustular)
- Indication for treatment by IL-23 inhibitor. Tildrakizumab must be the selected IL-23 inhibitor therapy prior to enrolling the patient in the study. Patients who have previously received previous treatment by IL-23 inhibitors may be included.
- Patient 18 years of age or older at the inclusion visit
Key exclusion criteria (9 listed)
- Patient unable to comply with study requirements (i.e.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.
- 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 assessmentsGlobal evaluation of psoriasis and specific evaluation by areas | Other | Single group |
| Quality of life evaluationDLQI questionnaire at each visit | Other | Single group |
| Satisfaction assessmentVisual analogic scale at W16, W28, W52 | Other | Single group |
| Pruritus evaluationVisual analogic scale at each visit | Other | Single group |
Primary outcome
Specific response to Tildrakizumab at W28
Time frame: Week 28
Percentage of response based on specific assessment on target area (75% improvement of the specific score compared to Baseline visit)
6 secondary outcomes
Overall response to Tildrakizumab
Time frame: Each visit (Week16-Week 28-Week 52)
Specific response to Tildrakizumab
Time frame: Week 16, week 28 and week 52
Adverse events
Time frame: From baseline visit to Week 52
Evaluation of pruritus under treatment
Time frame: Each visit (Baseline,Week 16, Week 28, Week 52)
Evaluation of quality of life under treatement
Time frame: Each visit (Baseline, Week16, Week 28, Week 52)
Evaluation of satisfaction under treatement
Time frame: Each follow-up visit (Week 16, Week 28, Week 52)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Ines ZARAA, MD principal investigator
Saint Joseph hospital Paris
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 Palmaris and Psoriasis Genital, 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 6 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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.