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)

NCT05959070 | Completed

• 1 other identifier: P23-435
• Study Type: observational
• Target: 154
• Locations: 3 countries
• Sites: 16

Brief Summary

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.

Conditions

Psoriasis

Keywords

Plaque Psoriasis; PsO; Psoriasis; Risankizumab; RZB

Outcome Measures

Primary Outcomes (3)

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

  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)

  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)

  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

Study Arms (1)

Risankizumab

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (16)

Universite Libre de Bruxelles - Hopital Erasme /ID# 252456

Anderlecht, Brussels Capital, 1070, Belgium

Location

Cliniques Universitaires UCL Saint-Luc /ID# 253234

Brussels, Brussels Capital, 1200, Belgium

Location

UZ Gent /ID# 252458

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Dermatologie Maldegem /ID# 252454

Maldegem, Oost-Vlaanderen, 9990, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 252457

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Wiseman Dermatology Research /ID# 255883

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Dermatrials Research /ID# 253879

Hamilton, Ontario, L8N 1Y2, Canada

Location

Lynde Institute for Dermatology /ID# 253876

Markham, Ontario, L3P 1X2, Canada

Location

JRB Research /ID# 253877

Ottawa, Ontario, K1H 7X3, Canada

Location

SKiN Centre for Dermatology /ID# 255882

Peterborough, Ontario, K9J 5K2, Canada

Location

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

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Hautarztpraxis Mortazawi /ID# 255872

Remscheid, North Rhine-Westphalia, 42897, Germany

Location

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

Dresden, 01109, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf /ID# 254340

Hamburg, 20246, Germany

Location

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

Heilbad Heiligenstadt, 37308, Germany

Location

Praxis Dres. Wiemers/Wiemers /ID# 255873

Leipzig, 04317, Germany

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: November 9, 2023
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CA (6); DE (5); BE (5)