PsoriasisIMMagineNCT05959070
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)
An observational study of Psoriasis, run by AbbVie at 16 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 154 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 9 Nov 2023to 21 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult moderate to severe Psoriasis participants treated with labeled dose of Risankizumab.
Who may be able to join
- 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.
Who cannot join
- Current or recent (within the last 30 days) participation in an interventional clinical trial.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Canada6 sites
Dermatrials Research /ID# 253879
Hamilton, Ontario, L8N 1Y2
Lynde Institute for Dermatology /ID# 253876
Markham, Ontario, L3P 1X2
JRB Research /ID# 253877
Ottawa, Ontario, K1H 7X3
SKiN Centre for Dermatology /ID# 255882
Peterborough, Ontario, K9J 5K2
Dre Angelique Gagne-Henley M.D. inc. /ID# 262591
Saint-Jérôme, Quebec, J7Z 7E2
Wiseman Dermatology Research /ID# 255883
Winnipeg, Manitoba, R3M 3Z4
Belgium5 sites
Universite Libre de Bruxelles - Hopital Erasme /ID# 252456
Anderlecht, Brussels Capital, 1070
Cliniques Universitaires UCL Saint-Luc /ID# 253234
Brussels, Brussels Capital, 1200
UZ Gent /ID# 252458
Ghent, Oost-Vlaanderen, 9000
Universitair Ziekenhuis Leuven /ID# 252457
Leuven, Vlaams-Brabant, 3000
Dermatologie Maldegem /ID# 252454
Maldegem, Oost-Vlaanderen, 9990
Germany5 sites
Dermatologische Praxis Dr. med. Marvin Kuske /ID# 265688
Dresden, 01109
Universitaetsklinikum Hamburg-Eppendorf /ID# 254340
Hamburg, 20246
Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 255874
Heilbad Heiligenstadt, 37308
Praxis Dres. Wiemers/Wiemers /ID# 255873
Leipzig, 04317
Hautarztpraxis Mortazawi /ID# 255872
Remscheid, North Rhine-Westphalia, 42897
About this study
Official title: 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.
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, PsO, Psoriasis, Risankizumab, RZB
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Participants will receive risankizumab as prescribed by their physician according to local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Baseline through Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start9 Nov 2023
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959070
- Sponsor's protocol ID
- P23-435
- Acronym
- IMMagine
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Country Prospective Real-World Study to Validate the CLCI Instrument (DermCLCI-p) in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (IMMagine)
- ClinicalTrials.gov ID
- NCT05959070
- Acronym / sponsor ID
- IMMagine / P23-435
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, PsO, Psoriasis, Risankizumab, RZB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risankizumab | – | –Participants will receive risankizumab as prescribed by their physician according to local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult moderate to severe Psoriasis participants treated with labeled dose of Risankizumab.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Current or recent (within the last 30 days) participation in an interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by AbbVie at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the Cumulative Life Course Impairment Instrument (DermCLCI-p) (time frame: Baseline through Week 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.