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)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05959070
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Canada, Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

: Risankizumab

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Anderlecht, Bruxelles-Capitale, Belgium

Status

Recruiting

Address

Université Libre de Bruxelles - Hôpital Erasme /ID# 252456

Anderlecht, Bruxelles-Capitale, 1070

UCL Saint-Luc /ID# 253234, Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium

Status

Recruiting

Address

UCL Saint-Luc /ID# 253234

Woluwe-Saint-Lambert, Bruxelles-Capitale, 1200

UZ Gent /ID# 252458, Gent, Oost-Vlaanderen, Belgium

Status

Recruiting

Address

UZ Gent /ID# 252458

Gent, Oost-Vlaanderen, 9000

Dermatologie Maldegem /ID# 252454, Maldegem, Oost-Vlaanderen, Belgium

Status

Recruiting

Address

Dermatologie Maldegem /ID# 252454

Maldegem, Oost-Vlaanderen, 9990

Leuven, Vlaams-Brabant, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Leuven /ID# 252457

Leuven, Vlaams-Brabant, 3000

Wiseman Dermatology Research /ID# 255883, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Wiseman Dermatology Research /ID# 255883

Winnipeg, Manitoba, R3M 3Z4

Dermatrials Research /ID# 253879, Hamilton, Ontario, Canada

Status

Recruiting

Address

Dermatrials Research /ID# 253879

Hamilton, Ontario, L8N 1Y2

Lynderm Research Inc. /ID# 253876, Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research Inc. /ID# 253876

Markham, Ontario, L3P 1X3

JRB Research /ID# 253877, Ottawa, Ontario, Canada

Status

Recruiting

Address

JRB Research /ID# 253877

Ottawa, Ontario, K1H 7X3

SKiN Centre for Dermatology /ID# 255882, Peterborough, Ontario, Canada

Status

Recruiting

Address

SKiN Centre for Dermatology /ID# 255882

Peterborough, Ontario, K9J 5K2

Saint-Jerome, Quebec, Canada

Status

Recruiting

Address

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

Saint-Jerome, Quebec, J7Z 7E2

Hautarztpraxis Mortazawi /ID# 255872, Remscheid, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Hautarztpraxis Mortazawi /ID# 255872

Remscheid, Nordrhein-Westfalen, 42897

Dresden, Germany

Status

Recruiting

Address

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

Dresden, , 01109

Hamburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Hamburg-Eppendorf /ID# 254340

Hamburg, , 20246

Heilbad Heiligenstadt, Germany

Status

Recruiting

Address

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

Heilbad Heiligenstadt, , 37308

Praxis Dres. Wiemers/Wiemers /ID# 255873, Leipzig, Germany

Status

Recruiting

Address

Praxis Dres. Wiemers/Wiemers /ID# 255873

Leipzig, , 04317

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