An Observational Study to Validate the Cumulative Life Course Impairment (CLCI) Instrument (DermCLCI-p) in Adult Participants With Moderate to Severe Chronic Plaque Psoriasis (PsO)

NCT ID: NCT05959070

Last Updated: 2025-05-02

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

COMPLETED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-09

Study Completion Date

2025-03-21

Brief Summary

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The IMMagine study aims to validate the newly developed CLCI instrument (DermCLCI-p) in moderate to severe psoriasis (PsO) patients, who will be started on Risankizumb (RZB) treatment and will be enrolled into the validation study up to 28 weeks. The treatment decision for RZB must be made independent of this study enrollment.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Risankizumab

Participants will receive risankizumab as prescribed by their physician according to local label.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a dermatologist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment.
* Participants initiating RZB treatment for psoriasis as per local label. Physician's decision for treatment with risankizumab must have been reached prior to and independently of recruitment in the study.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Willingness and ability to comply with all study requirements.

Exclusion Criteria

\- Current or recent (within the last 30 days) participation in an interventional clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Universite Libre de Bruxelles - Hopital Erasme /ID# 252456

Anderlecht, Brussels Capital, Belgium

Site Status

Cliniques Universitaires UCL Saint-Luc /ID# 253234

Brussels, Brussels Capital, Belgium

Site Status

UZ Gent /ID# 252458

Ghent, Oost-Vlaanderen, Belgium

Site Status

Dermatologie Maldegem /ID# 252454

Maldegem, Oost-Vlaanderen, Belgium

Site Status

Universitair Ziekenhuis Leuven /ID# 252457

Leuven, Vlaams-Brabant, Belgium

Site Status

Wiseman Dermatology Research /ID# 255883

Winnipeg, Manitoba, Canada

Site Status

Dermatrials Research /ID# 253879

Hamilton, Ontario, Canada

Site Status

Lynde Institute for Dermatology /ID# 253876

Markham, Ontario, Canada

Site Status

JRB Research /ID# 253877

Ottawa, Ontario, Canada

Site Status

SKiN Centre for Dermatology /ID# 255882

Peterborough, Ontario, Canada

Site Status

Dre Angelique Gagne-Henley M.D. inc. /ID# 262591

Saint-Jérôme, Quebec, Canada

Site Status

Hautarztpraxis Mortazawi /ID# 255872

Remscheid, North Rhine-Westphalia, Germany

Site Status

Dermatologische Praxis Dr. med. Marvin Kuske /ID# 265688

Dresden, , Germany

Site Status

Universitaetsklinikum Hamburg-Eppendorf /ID# 254340

Hamburg, , Germany

Site Status

Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 255874

Heilbad Heiligenstadt, , Germany

Site Status

Praxis Dres. Wiemers/Wiemers /ID# 255873

Leipzig, , Germany

Site Status

Countries

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Belgium Canada Germany

Related Links

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Other Identifiers

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P23-435

Identifier Type: -

Identifier Source: org_study_id

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