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) (IMMagine)

March 23, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Universite Libre de Bruxelles - Hopital Erasme /ID# 252456
      • Brussels, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires UCL Saint-Luc /ID# 253234
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 252458
      • Maldegem, Oost-Vlaanderen, Belgium, 9990
        • Dermatologie Maldegem /ID# 252454
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 252457
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research /ID# 255883
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research /ID# 253879
      • Markham, Ontario, Canada, L3P 1X2
        • Lynde Institute for Dermatology /ID# 253876
      • Ottawa, Ontario, Canada, K1H 7X3
        • JRB Research /ID# 253877
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKiN Centre for Dermatology /ID# 255882
    • Quebec
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Dre Angelique Gagne-Henley M.D. inc. /ID# 262591
  • Germany
      • Dresden, Germany, 01109
        • Dermatologische Praxis Dr. med. Marvin Kuske /ID# 265688
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf /ID# 254340
      • Heilbad Heiligenstadt, Germany, 37308
        • Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 255874
      • Leipzig, Germany, 04317
        • Praxis Dres. Wiemers/Wiemers /ID# 255873
    • North Rhine-Westphalia
      • Remscheid, North Rhine-Westphalia, Germany, 42897
        • Hautarztpraxis Mortazawi /ID# 255872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult moderate to severe Psoriasis participants treated with labeled dose of Risankizumab.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Risankizumab
Participants will receive risankizumab as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline through Week 28
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).
Baseline through Week 28
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).
Baseline through Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Actual)

March 21, 2025

Study Completion (Actual)

March 21, 2025

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P23-435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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