Pustular Psoriasis (PP)IRASPENNCT04359394
International Rare And Severe Psoriasis Expert Network
An observational study of Pustular Psoriasis (PP), run by University Hospital, Basel, Switzerland at 8 sites in 6 countries.
Trial summary
This registry is a prospective observational study in order to describe primarily the natural course of PP subtypes and to gain detailed information about their phenotype. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Pustular Psoriasis (PP)
- What is being tested?
- biological sampling, Phenotypic description and Photography
- How many people
- 180 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 22 Sep 2021to Dec 2030
- How long will I take part?
- 5 Years
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The project population encompasses all patients aged 6 months and over with active PP in the participating countries. Patients will be recruited by consecutive ongoing recruitment in the investigators' clinical practice during 5 years.
Who may be able to join
- Written informed consent of the patient or legal proxy in the registry
- Diagnosis of PP confirmed by a dermatologist in the participant. The type of PP can be any one of PPP, GPP/Acute Generalized Exanthematous Pustulosis (AGEP), ACH or a mixed phenotype, according to the judgment of the investigator
- GPP: Primary, sterile, macroscopically visible epidermal pustules on non-acral Skin with or without systemic Inflammation; with or without plaque psoriasis; either relapsing (>1 episode) or persistent (>3 months)
- PPP: Primary, persistent (>3 months), sterile, macroscopically visible epidermal pustules on palms and/or soles with or without plaque psoriasis
- ACH: Primary, persistent (>3 months), sterile, macroscopically visible epidermal pustules affecting the nail apparatus with or without plaque psoriasis
- At the timepoint of inclusion, the participant must have had active pustulation with either white, yellow or brown pustules within six month before baseline. Active postulation at baseline is not mandatory for inclusion.
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- Sufficient language skills (in the languages which the patient information and the consent form is available) for the informed consent to participate
- Patients of all ancestries and skin pigment type can be included
- Direct non-affected adult (>18 years old) relatives of the participant (up to two, namely mother, father, sibling) with the purpose to provide DNA for family trio sequencing analysis. The patient is not excluded from the study if no relatives are included.
Who cannot join
- Any medical or psychological condition in the treating physician's opinion which may prevent the patient in registry participation for the next 5 years
- Lack of informed consent for registry participation
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
Switzerland2 sites, 2 recruiting
- Recruiting
Dermatology, University Hospital Basel
Basel, 4031
Alexander Navarini, Prof. Dr. med. Dr. sc. nat., +41 61 328 60 80, alexander.navarini@usb.ch
Alexander Navarini, Prof. Dr. med.
- Recruiting
University Hospital Zürich
Zurich, 8058
Julia-Tatjana Maul, PD Dr. med., + 41 79 50 44197, Julia-Tatjana.Maul@usz.ch
Julia-Tatjana Maul, PD Dr. med.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Akdeniz University School of Medicine; Department of Dermatology and Venereology
Antalya, 07059
Erkan Alpsoy, MD, MPhil, +90-242-2496706, ealpsoy@akdeniz.edu.tr
Erkan Alpsoy, MD, MPhil
- Recruiting
Trakya University, Faculty of Medicine; Department of Dermatology and Venereology
Edirne
Sezgi Sarikaya Solak, Asst. Prof., +90 (284) 235 76 41, sezgisarikaya@gmail.com
Sezgi Sarikaya Solak, Asst. Prof.
Germany1 site, 1 recruiting
- Recruiting
Klinikum der Universität München
München, 80337
Lars E. French, Prof. Dr. med. Dr. sc. nat., +49 (0) 89 4400-56010, Lars.French@med.uni-muenchen.de
Lars E. French, Prof. Dr. med. Dr. sc. nat.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS
Rome, 00168
Andrea Chiricozzi, Dr. med., +39 06 30 15 42 11, andrea.chiricozzi2@policlinicogemelli.it
Andrea Chiricozzi, Dr. med.
Portugal1 site, 1 recruiting
- Recruiting
Universitário do Porto
Porto, 4150-117
Tiago Torres, MD PhD, +351 226097429, torres.tiago@outlook.com
Tiago Torres, MD PhD
Singapore1 site, 1 recruiting
- Recruiting
National Skin Centre
Singapore, 308205
Hazel Oon, Dr. med., +65 62 53 44 55, hazeloon@nsc.com.sg
Hazel Oon, Dr. med.
About this study
Official title: International Rare And Severe Psoriasis Expert Network (IRASPEN) - A Prospective Registry With Genotype-Phenotype Correlation
This registry is a prospective observational study in order to describe primarily the natural course of PP subtypes and to gain detailed information about their phenotype.
Read the detailed description
This project is to describe the natural course of disease in different subtypes of PP. The network builds on a static registry that was based on a one-time clinical characterization of PP patients in Europe (ERASPEN). The International Rare and Severe Psoriasis Expert Network (IRASPEN) already has multiple clinicians involved who have successfully characterized and included their patients in ERASPEN. IRASPEN addresses the question of temporal evolution of clinical features and is actually a non-interventional prospective registry that aims to describe the clinical course and responses to already established treatments of a large number of PP patients over a period of 5 years. The data collection with this registry will give insight on the natural course of PP disease revealing the burden of disease including frequency and severity of flares and the role of therapeutic interventions.
- Conditions
- Pustular Psoriasis (PP)
- Being tested
- biological sampling, Phenotypic description, Photography
- Keywords
- Palmoplantar Psoriasis (PPP), IRASPEN International Rare and Severe Psoriasis Expert Network, ERASPEN European Rare and Severe Psoriasis Expert Network, Psoriasis, Generalized pustular psoriasis (GPP), Acrodermatitis continua of Hallopeau (ACH), Interleukin 36 Receptor Antagonist Gene (IL36RN), Caspase Recruitment Domain-containing protein 14 (CARD14), Adaptor Related Protein Complex 1 Subunit Sigma 3 (AP1S3)
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplingOther
In order to investigate the level of molecular pathophysiology, blood and punch biopsies will be collected of each patient. In up to two relatives per patient, 30mL blood will be collected only once.
Phenotypic descriptionOther
Phenotypic characterization of the patient's clinical features
PhotographyOther
All affected areas will be photographed at each visit with 2-dimensional standardized photography
| Study group | Role | What they receive |
|---|---|---|
| PP patients | patients with active PP Receives: Other: biological sampling; Other: Phenotypic description; Other: Photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physician Global Assessment (PGA)
modified PGA (physician's assessment of psoriatic lesions) scoring the erythema, pustules, and scaling of all GPP or PPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final PGA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear.
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Secondary outcomes (11)
Change in Generalized Pustular Psoriasis (GPP) Area and Severity Index (GPPASI)
Measure of severity and area of psoriatic lesions in patients with psoriasis. It is a tool that provides a numeric scoring for a patient's overall GPP disease state,ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected by erythema, pustules and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions.
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) consists of 10 questions concerning patient's perception of the impact of skin diseases on different aspects of their health related QoL over the last week. The DLQI evaluates the impact of the patient's skin disease on daily activities, leisure, work and personal relationships. Each question is scored on a 4-point Likert scale.
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in EuroQol (EQ-5D)
The EuroQol is a generic questionnaire. It is a preference based health status and multi attribute utility scale that produces a single index score for each state of health. These score ranges from 0 to 1, where 1 is equivalent to full health and 0 equivalent to death
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH)
The Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH) consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS)[
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in psoriasis symptom scale (PSS)
The psoriasis symptom scale (PSS) is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives to be. The scale also includes a number of direct queries about current levels of experienced stress. Moreover, the questions are of a general nature and hence are relatively free of content specific to any sub-population group. The questions in the PSS ask about feelings and thoughts during the last month.
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Disease activity Visual analogue Scale (VAS)
The disease VAS is a unidimensional measure of disease intensity. The VAS is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not given. The disease intensity VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their current disease intensity.
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Pain Visual analogue Scale (VAS)
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The pain VAS is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not given. The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity.
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Number of flares in the last 2 years
Number of flares in the last 2 years
Measured: at Baseline
Number of flares since the last visit
Number of flares since the last visit
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Palmoplantar Pustulosis (PPP) Area and Severity Index (PPPASI)
investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 to 72. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation).
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Psoriasis Area and Severity Index (PASI)
The Psoriasis Area and Severity Index (PASI) is a composite variable used to assess the severity of Psoriasis. The PASI evaluates the area of psoriatic involvement in 4 main areas (head, trunk, upper and lower extremities) and the severity of the psoriatic lesions with respect to three target symptoms: erythema, infiltration and desquamation (actual percentages of area involvement) .
Measured: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start22 Sep 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pustular Psoriasis (PP)Studies 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
- 180 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Alexander Navarini, Prof. Dr. med. Dr. sc. nat., Principal investigator, Dermatologie, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359394
- Sponsor's protocol ID
- 2020-00425; sp18Navarini2
- Acronym
- IRASPEN
- Status last verified
- May 2024
- First submitted
- 21 Apr 2020
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Rare And Severe Psoriasis Expert Network (IRASPEN) - A Prospective Registry With Genotype-Phenotype Correlation
- ClinicalTrials.gov ID
- NCT04359394
- Acronym / sponsor ID
- IRASPEN / 2020-00425; sp18Navarini2
- Conditions
- Pustular Psoriasis (PP)
- Keywords
- Palmoplantar Psoriasis (PPP), IRASPEN International Rare and Severe Psoriasis Expert Network, ERASPEN European Rare and Severe Psoriasis Expert Network, Psoriasis, Generalized pustular psoriasis (GPP), Acrodermatitis continua of Hallopeau (ACH), Interleukin 36 Receptor Antagonist Gene (IL36RN), Caspase Recruitment Domain-containing protein 14 (CARD14)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 24 Apr 2020 (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 registry is a prospective observational study in order to describe primarily the natural course of PP subtypes and to gain detailed information about their phenotype.
Detailed description
This project is to describe the natural course of disease in different subtypes of PP. The network builds on a static registry that was based on a one-time clinical characterization of PP patients in Europe (ERASPEN). The International Rare and Severe Psoriasis Expert Network (IRASPEN) already has multiple clinicians involved who have successfully characterized and included their patients in ERASPEN. IRASPEN addresses the question of temporal evolution of clinical features and is actually a non-interventional prospective registry that aims to describe the clinical course and responses to already established treatments of a large number of PP patients over a period of 5 years. The data collection with this registry will give insight on the natural course of PP disease revealing the burden of disease including frequency and severity of flares and the role of therapeutic interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PP patients | – | Other: biological sampling, Other: Phenotypic description, Other: Photographypatients with active PP |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The project population encompasses all patients aged 6 months and over with active PP in the participating countries. Patients will be recruited by consecutive ongoing recruitment in the investigators' clinical practice during 5 years.
Key inclusion criteria (9 listed)
- Written informed consent of the patient or legal proxy in the registry
- Diagnosis of PP confirmed by a dermatologist in the participant. The type of PP can be any one of PPP, GPP/Acute Generalized Exanthematous Pustulosis (AGEP), ACH or a mixed phenotype, according to the judgment of the investigator
- GPP: Primary, sterile, macroscopically visible epidermal pustules on non-acral Skin with or without systemic Inflammation; with or without plaque psoriasis; either relapsing (>1 episode) or persistent (>3 months)
- PPP: Primary, persistent (>3 months), sterile, macroscopically visible epidermal pustules on palms and/or soles with or without plaque psoriasis
- ACH: Primary, persistent (>3 months), sterile, macroscopically visible epidermal pustules affecting the nail apparatus with or without plaque psoriasis
Key exclusion criteria (2 listed)
- Any medical or psychological condition in the treating physician's opinion which may prevent the patient in registry participation for the next 5 years
- Lack of informed consent for registry participation
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 |
|---|---|---|
| biological samplingIn order to investigate the level of molecular pathophysiology, blood and punch biopsies will be collected of each patient. In up to two relatives per patient, 30mL blood will be collected only once. | Other | PP patients |
| Phenotypic descriptionPhenotypic characterization of the patient's clinical features | Other | PP patients |
| PhotographyAll affected areas will be photographed at each visit with 2-dimensional standardized photography | Other | PP patients |
Primary outcome
Change in Physician Global Assessment (PGA)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
modified PGA (physician's assessment of psoriatic lesions) scoring the erythema, pustules, and scaling of all GPP or PPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final PGA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear.
11 secondary outcomes
Change in Generalized Pustular Psoriasis (GPP) Area and Severity Index (GPPASI)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Dermatology Life Quality Index (DLQI)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in EuroQol (EQ-5D)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in psoriasis symptom scale (PSS)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Disease activity Visual analogue Scale (VAS)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Pain Visual analogue Scale (VAS)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Number of flares in the last 2 years
Time frame: at Baseline
Number of flares since the last visit
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Palmoplantar Pustulosis (PPP) Area and Severity Index (PPPASI)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
Change in Psoriasis Area and Severity Index (PASI)
Time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260
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 9 May 2024.
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.
Alexander Navarini, Prof. Dr. med. Dr. sc. nat. principal investigator
Dermatologie, Universitätsspital Basel
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pustular Psoriasis (PP), run by University Hospital, Basel, Switzerland at 8 sites in 6 countries.
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 9 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: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland, Turkey (Türkiye), Germany, Italy, Portugal and 1 more country. 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?
Contact Alexander Navarini, Prof. Dr. med. Dr. sc. nat. (+41 61 328 60 80, alexander.navarini@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physician Global Assessment (PGA) (time frame: At Baseline, week 12, week 24, week 52, week 104, week 156, week 208, week 260). 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 9 May 2024.