Plaque PsoriasisPOSITIVENCT04823247
Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study
An observational study of Plaque Psoriasis, run by Almirall, S.A. at 1 site in Germany.
Trial summary
This is an ethics-approved, multi-national, multi-site Phase IV, 1-cohort prospective observational study. The main purpose of this study is to assess the effect of tildrakizumab on the overall wellbeing in patients with moderate-to-severe psoriasis using the 5-item World Health Organization Wellbeing Index (WHO-5)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Tildrakizumab
- How many people
- 782 participants
- Where
- 1 siteGermany
- Study dates
- 22 Nov 2021to 9 Jan 2025
- How long will I take part?
- 24 Months
- 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: The study population consists of patients with moderate-to-severe plaque psoriasis who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor treatment in real-world clinical practice.
Who may be able to join
- Patient with diagnosis of moderate-to-severe chronic plaque psoriasis documented in the medical chart.
- Patient who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-IL-23p19 selected therapy before including the patient in the study.
- Patient aged 18 years or older at the time of patient recruitment.
- Patient who have provided written informed consent (if required by country regulations).
Who cannot join
- Patients unable to comply with the requirements of the study (fulfilling of the study questionnaires) or who, in the opinion of the study physician, should not participate in the study.
- Patients included in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study
This is an ethics-approved, multi-national, multi-site Phase IV, 1-cohort prospective observational study. The main purpose of this study is to assess the effect of tildrakizumab on the overall wellbeing in patients with moderate-to-severe psoriasis using the 5-item World Health Organization Wellbeing Index (WHO-5) questionnaire.
- Conditions
- Plaque Psoriasis
- Being tested
- Tildrakizumab
- Keywords
- Moderate-to-severe plaque psoriasis, Psoriasis, Tildrakizumab, Prospective
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TildrakizumabDrug
Also called IL-23p19 inhibitor
As provided in real world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Tildrakizumab | Patients diagnosed with moderate-to-severe plaque psoriasis who require systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor in real-world clinical practice, following the routine clinical practice on each patient country, will be observed for 24 months. Receives: Drug: Tildrakizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
Measured: Baseline and Month 24
Secondary outcomes (12)
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
Measured: Baseline; 16 and 28 weeks; 12, 18 months after baseline visit
Change from Baseline in Physician's Satisfaction Questionnaire Score
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in FamilyPso Questionnaire Score
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Dermatology Life Quality Index-Relevant (DLQI-R) Score
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Treatment-related Patient Benefit Index 2.0 (PBI 2.0) Score
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) Score
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Skin Manifestations Distribution (Patient's Grid/Heat Map)
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in Numerical Rating Scale (NRS) Scores for Itch, Pain, Joint Pain and Fatigue
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in Psoriasis Area and Severity Index (PASI) Score
Measured: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics
Measured: From Baseline up to 24 months
Number of Patients With Treatment-emergent Adverse Events (TEAE)
Measured: From Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start22 Nov 2021
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- 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
- 782 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823247
- Sponsor's protocol ID
- M-14745-47
- Acronym
- POSITIVE
- Status last verified
- May 2025
- First submitted
- 24 Mar 2021
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mrowietz U, Sommer R, Reguiai Z, Gerdes S, Dauden E, Weger W, Maul JT, Naldi L, Ghislain PD, Laws PM, De Jong EMGJ, Mburu S, Koscielny V, Massana E, Sapena V, Domenech A, Kasujee I, Augustin M. Patient-Reported Well-Being in Value-Based Routine Care in Psoriatic Disease Using Tildrakizumab: 2-Year Data of the Phase IV POSITIVE Study. Psoriasis (Auckl). 2026 May 12;16:590189. doi: 10.2147/PTT.S590189. eCollection 2026.
PubMed 42146323Mrowietz U, Sommer R, Gerdes S, Reguiai Z, Weger W, Dauden E, Maul JT, Ghislain PD, Laws PM, Naldi L, De Jong E, Mburu S, Koscielny V, Massana E, Domenech A, Gaarn du Jardin K, Kasujee I, Augustin M. Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study. Psoriasis (Auckl). 2025 Jun 28;15:243-259. doi: 10.2147/PTT.S526748. eCollection 2025.
PubMed 40605963Augustin M, Sommer R, Dauden E, Laws P, de Jong E, Fabbrocini G, Naldi L, Navarini A, Lambert J, Reguiai Z, Gerdes S, Massana E, Obis T, Kasujee I, Mrowietz U. Patient-reported well-being in value-based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study). BMJ Open. 2023 Feb 15;13(2):e060536. doi: 10.1136/bmjopen-2021-060536.
PubMed 36792337
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study
- ClinicalTrials.gov ID
- NCT04823247
- Acronym / sponsor ID
- POSITIVE / M-14745-47
- Conditions
- Plaque Psoriasis
- Keywords
- Moderate-to-severe plaque psoriasis, Psoriasis, Tildrakizumab, Prospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 30 Mar 2021 (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.
This is an ethics-approved, multi-national, multi-site Phase IV, 1-cohort prospective observational study. The main purpose of this study is to assess the effect of tildrakizumab on the overall wellbeing in patients with moderate-to-severe psoriasis using the 5-item World Health Organization Wellbeing Index (WHO-5) questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tildrakizumab | – | Drug: TildrakizumabPatients diagnosed with moderate-to-severe plaque psoriasis who require systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor in real-world clinical practice, following the routine clinical practice on each patient country, will be observed for 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with moderate-to-severe plaque psoriasis who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor treatment in real-world clinical practice.
Key inclusion criteria (4 listed)
- Patient with diagnosis of moderate-to-severe chronic plaque psoriasis documented in the medical chart.
- Patient who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-IL-23p19 selected therapy before including the patient in the study.
- Patient aged 18 years or older at the time of patient recruitment.
- Patient who have provided written informed consent (if required by country regulations).
Key exclusion criteria (2 listed)
- Patients unable to comply with the requirements of the study (fulfilling of the study questionnaires) or who, in the opinion of the study physician, should not participate in the study.
- Patients included in a clinical trial.
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 |
|---|---|---|
| TildrakizumabAlso: IL-23p19 inhibitorAs provided in real world clinical practice. | Drug | Tildrakizumab |
Primary outcome
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
Time frame: Baseline and Month 24
12 secondary outcomes
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 months after baseline visit
Change from Baseline in Physician's Satisfaction Questionnaire Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in FamilyPso Questionnaire Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Dermatology Life Quality Index-Relevant (DLQI-R) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Treatment-related Patient Benefit Index 2.0 (PBI 2.0) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Skin Manifestations Distribution (Patient's Grid/Heat Map)
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in Numerical Rating Scale (NRS) Scores for Itch, Pain, Joint Pain and Fatigue
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics
Time frame: From Baseline up to 24 months
Number of Patients With Treatment-emergent Adverse Events (TEAE)
Time frame: From Baseline up to 24 months
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 11 May 2025.
- Derived from this study: PubMed 42146323Mrowietz U, Sommer R, Reguiai Z, Gerdes S, Dauden E, Weger W, Maul JT, Naldi L, Ghislain PD, Laws PM, De Jong EMGJ, Mburu S, Koscielny V, Massana E, Sapena V, Domenech A, Kasujee I, Augustin M. Patient-Reported Well-Being in Value-Based Routine Care in Psoriatic Disease Using Tildrakizumab: 2-Year Data of the Phase IV POSITIVE Study. Psoriasis (Auckl). 2026 May 12;16:590189. doi: 10.2147/PTT.S590189. eCollection 2026.
- Derived from this study: PubMed 40605963Mrowietz U, Sommer R, Gerdes S, Reguiai Z, Weger W, Dauden E, Maul JT, Ghislain PD, Laws PM, Naldi L, De Jong E, Mburu S, Koscielny V, Massana E, Domenech A, Gaarn du Jardin K, Kasujee I, Augustin M. Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study. Psoriasis (Auckl). 2025 Jun 28;15:243-259. doi: 10.2147/PTT.S526748. eCollection 2025.
- Derived from this study: PubMed 36792337Augustin M, Sommer R, Dauden E, Laws P, de Jong E, Fabbrocini G, Naldi L, Navarini A, Lambert J, Reguiai Z, Gerdes S, Massana E, Obis T, Kasujee I, Mrowietz U. Patient-reported well-being in value-based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study). BMJ Open. 2023 Feb 15;13(2):e060536. doi: 10.1136/bmjopen-2021-060536.
- Individual participant dataSharing planned: No
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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 Plaque Psoriasis, run by Almirall, S.A. at 1 site in Germany.
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 4 inclusion and 2 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 11 May 2025. 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 Germany. 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?
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score (time frame: Baseline and Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823247, which also lists 3 linked publications.
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 11 May 2025.