International Rare And Severe Psoriasis Expert Network

NCT ID: NCT04359394

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-22

Study Completion Date

2030-12-31

Brief Summary

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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

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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

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Pustular Psoriasis (PP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PP patients

patients with active PP

biological sampling

Intervention Type OTHER

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 description

Intervention Type OTHER

Phenotypic characterization of the patient's clinical features

Photography

Intervention Type OTHER

All affected areas will be photographed at each visit with 2-dimensional standardized photography

Interventions

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biological sampling

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.

Intervention Type OTHER

Phenotypic description

Phenotypic characterization of the patient's clinical features

Intervention Type OTHER

Photography

All affected areas will be photographed at each visit with 2-dimensional standardized photography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Navarini, Prof. Dr. med. Dr. sc. nat.

Role: PRINCIPAL_INVESTIGATOR

Dermatologie, Universitätsspital Basel

Locations

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Klinikum der Universität München

München, , Germany

Site Status RECRUITING

Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS

Rome, , Italy

Site Status RECRUITING

Universitário do Porto

Porto, , Portugal

Site Status RECRUITING

National Skin Centre

Singapore, , Singapore

Site Status RECRUITING

Dermatology, University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

University Hospital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Akdeniz University School of Medicine; Department of Dermatology and Venereology

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Trakya University, Faculty of Medicine; Department of Dermatology and Venereology

Edirne, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Germany Italy Portugal Singapore Switzerland Turkey (Türkiye)

Central Contacts

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Alexander Navarini, Prof. Dr. med. Dr. sc. nat.

Role: CONTACT

+41 61 328 60 80

Facility Contacts

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Lars E. French, Prof. Dr. med. Dr. sc. nat.

Role: primary

+49 (0) 89 4400-56010

Andrea Chiricozzi, Dr. med.

Role: primary

+39 06 30 15 42 11

Tiago Torres, MD PhD

Role: primary

+351 226097429

Hazel Oon, Dr. med.

Role: primary

+65 62 53 44 55

Alexander Navarini, Prof. Dr. med. Dr. sc. nat.

Role: primary

+41 61 328 60 80

Julia-Tatjana Maul, PD Dr. med.

Role: primary

+ 41 79 50 44197

Erkan Alpsoy, MD, MPhil

Role: primary

+90-242-2496706

Sezgi Sarikaya Solak, Asst. Prof.

Role: primary

+90 (284) 235 76 41

Other Identifiers

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2020-00425; sp18Navarini2

Identifier Type: -

Identifier Source: org_study_id

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