PsoriasisNCT04818385
Study to Assess the Change in Disease State When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Taiwan
An observational study of Psoriasis, run by AbbVie at 8 sites in Taiwan.
Trial summary
Psoriasis (PsO) is a chronic, disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques and is associated with high burden of illness that results in a negative impact on long-term health outcomes including quality of life (QoL). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 240 participants
- Where
- 8 sitesTaiwan
- Study dates
- 31 May 2021to 1 Aug 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with moderate to severe plaque psoriasis.
Who may be able to join
- Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist t at the time of recruitment.
- Initiating an approved biologic treatment for psoriasis as per regulatory and reimbursement policy in Taiwan. Physician's decision with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.
- Treatments prescribed in accordance to both the product monograph, regulatory and reimbursement policies in Taiwan.
Who cannot join
- Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in another PMOS or Registry is acceptable.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
National Taiwan University Hospital - Hsinchu branch /ID# 238432
Hsinchu, 30059
Hualien Tzu Chi Hospital /ID# 238431
Hualien City, 97002
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 230016
Kaohsiung City, 807
China Medical University Hospital /ID# 229961
Taichung, 40447
National Cheng Kung University Hospital /ID# 253776
Tainan, 704
Taipei Medical University Hospital /ID# 230018
Taipei, 11031
National Taiwan University Hospital /ID# 230017
Taipei City, Taipei, 100
Linkou Chang Gung Memorial Hospital /ID# 253775
Taoyuan City, 333
About this study
Official title: Prospective Observational Cohort Study of Patients With Moderate to Severe Chronic Plaque Psoriasis in Taiwan
Psoriasis (PsO) is a chronic, disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques and is associated with high burden of illness that results in a negative impact on long-term health outcomes including quality of life (QoL). The main objective of this study is to characterize the durability of response of risankizumab compared to other biologics measured by the Psoriasis Area and Severity Index (PASI) 90 response in adult participants with moderate to severe chronic plaque psoriasis who are either new or have used a biological treatment in the past.
Risankizumab is a drug approved for the treatment of moderate-to-severe plaque psoriasis. Participants who are prescribed risankizumab or other comparator drugs in the real world setting are enrolled in this study. Data from a total of approximately 240 participants; 160 using risankizumab and 80 using other biologics will be evaluated across Taiwan.
Read more
Participants will receive subcutaneous risankizumab injection or or other biologic as prescribed by their physician. Data from these participants will be collected for approximately 2 years.
There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Risankizumab, Skyrizi, Plaque Psoriasis
- 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 |
|---|---|---|
| Participants Receiving Risankizumab | Participants will receive risankizumab as prescribed by their physician. | |
| Participants Receiving All Other Biologics | Participants will receive all other biologics as prescribed by their physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Week 24
Secondary outcomes (18)
Time of First Treatment Change
Time of first treatment change is defined as any treatment change including discontinuation, dose escalation and dosing interval shortening.
Measured: Up to Week 108
The Percentage of Participants who Achieved PASI 75
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to Week 108
The Percentage of Participants who Achieved PASI 90
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to Week 108
The Percentage of Participants who Achieved PASI 100
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to Week 108
Percentage of Participants who Achieved Absolute PASI<=5
The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction.
Measured: Up to Week 108
Percentage of Participants who Achieved Absolute PASI<=3
The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction.
Measured: Up to Week 108
Percentage of Participants who Achieved Absolute PASI<=1
The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction.
Measured: Up to Week 108
The Percentage of Participants who Achieved Dermatology Life Quality Index (DLQI) 0/1
DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where the higher the score, the more the quality of life is impaired.
Measured: Up to Week 108
Time to Achieved PASI 75
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to Week 108
Time to Achieved PASI 100
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to Week 108
Time to Achieved PASI 90
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to Week 108
The Percentage of Participants who Achieved PASI 90 at 24 Weeks and Maintained the Response Without Changing the Indicated Dose or Dosing Interval
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to Week 108
Change from Baseline in PASI
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to Week 108
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis
BSA affected by psoriasis as assessed by the Investigator.
Measured: Up to Week 108
Change from Baseline in DLQI
DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where the higher the score, the more the quality of life is impaired.
Measured: Up to Week 108
Number of Participants with Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
Measured: Up to Week 108
Time to Reach Absolute PASI 10 After Withdraw from Latest Biologic Therapy
The absolute PASI is used to assess the benefit of psoriasis therapy, with a higher score indicating a greater percent reduction.
Measured: Up to 5 years Medical Chart Review Prior to Enrollment
Time to Reach Loss of PASI 50 After Withdraw from Latest Biologic Therapy
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
Measured: Up to 5 years Medical Chart Review Prior to Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start31 May 2021
- Primary completion1 Aug 2025
- Study completion1 Aug 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
- 240 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
- NCT04818385
- Sponsor's protocol ID
- P20-272
- Status last verified
- Sep 2025
- First submitted
- 24 Mar 2021
- Last updated
- 17 Sep 2025
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study of Patients With Moderate to Severe Chronic Plaque Psoriasis in Taiwan
- ClinicalTrials.gov ID
- NCT04818385
- Acronym / sponsor ID
- P20-272
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Risankizumab, Skyrizi, Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 26 Mar 2021 (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.
Psoriasis (PsO) is a chronic, disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques and is associated with high burden of illness that results in a negative impact on long-term health outcomes including quality of life (QoL). The main objective of this study is to characterize the durability of response of risankizumab compared to other biologics measured by the Psoriasis Area and Severity Index (PASI) 90 response in adult participants with moderate to severe chronic plaque psoriasis who are either new or have used a biological treatment in the past.
Risankizumab is a drug approved for the treatment of moderate-to-severe plaque psoriasis. Participants who are prescribed risankizumab or other comparator drugs in the real world setting are enrolled in this study. Data from a total of approximately 240 participants; 160 using risankizumab and 80 using other biologics will be evaluated across Taiwan.
Participants will receive subcutaneous risankizumab injection or or other biologic as prescribed by their physician. Data from these participants will be collected for approximately 2 years.
There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Risankizumab | – | –Participants will receive risankizumab as prescribed by their physician. |
| Participants Receiving All Other Biologics | – | –Participants will receive all other biologics as prescribed by their physician. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with moderate to severe plaque psoriasis.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist t at the time of recruitment.
- Initiating an approved biologic treatment for psoriasis as per regulatory and reimbursement policy in Taiwan. Physician's decision with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.
- Treatments prescribed in accordance to both the product monograph, regulatory and reimbursement policies in Taiwan.
Key exclusion criteria (1 listed)
- Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in another PMOS or Registry is acceptable.
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
The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90
Time frame: Week 24
The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.
18 secondary outcomes
Time of First Treatment Change
Time frame: Up to Week 108
The Percentage of Participants who Achieved PASI 75
Time frame: Up to Week 108
The Percentage of Participants who Achieved PASI 90
Time frame: Up to Week 108
The Percentage of Participants who Achieved PASI 100
Time frame: Up to Week 108
Percentage of Participants who Achieved Absolute PASI<=5
Time frame: Up to Week 108
Percentage of Participants who Achieved Absolute PASI<=3
Time frame: Up to Week 108
Percentage of Participants who Achieved Absolute PASI<=1
Time frame: Up to Week 108
The Percentage of Participants who Achieved Dermatology Life Quality Index (DLQI) 0/1
Time frame: Up to Week 108
Time to Achieved PASI 75
Time frame: Up to Week 108
Time to Achieved PASI 100
Time frame: Up to Week 108
Time to Achieved PASI 90
Time frame: Up to Week 108
The Percentage of Participants who Achieved PASI 90 at 24 Weeks and Maintained the Response Without Changing the Indicated Dose or Dosing Interval
Time frame: Up to Week 108
Change from Baseline in PASI
Time frame: Up to Week 108
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis
Time frame: Up to Week 108
Change from Baseline in DLQI
Time frame: Up to Week 108
Number of Participants with Adverse Events (AE)
Time frame: Up to Week 108
Time to Reach Absolute PASI 10 After Withdraw from Latest Biologic Therapy
Time frame: Up to 5 years Medical Chart Review Prior to Enrollment
Time to Reach Loss of PASI 50 After Withdraw from Latest Biologic Therapy
Time frame: Up to 5 years Medical Chart Review Prior to Enrollment
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 17 Sep 2025.
- Related InfoLink provided by the sponsor.
- 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
8 sites in 1 country: 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 8 sites in Taiwan.
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 3 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. 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?
The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90 (time frame: Week 24). 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 17 Sep 2025.