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)

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universite Libre de Bruxelles - Hopital Erasme /ID# 252456, Anderlecht, Brussels Capital, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Validity of the Cumulative Life Course Impairment Instrument (DermCLCI-p)

Time frame: Baseline through Week 28

The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).
Reliability of the Cumulative Life Course Impairment Instrument (DermCLCI-p)

Time frame: Baseline through Week 28

The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).
Responsiveness of the Cumulative Life Course Impairment Instrument (DermCLCI-p)

Time frame: Baseline through Week 28

The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Multi-Country Prospective Real-World Study to Validate the CLCI Instrument (DermCLCI-p) in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (IMMagine)

Acronym: IMMagine

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Jul 25, 2023
Registry last updated: Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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