PsoriasisUNMASK2NCT04894890
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
An observational study of Psoriasis, run by Novartis Pharmaceuticals at 42 sites in China.
Trial summary
This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- secukinumab
- How many people
- 1,002 participants
- Where
- 42 sitesChina
- Study dates
- 26 Sep 2021to 15 Dec 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed diagnosis of moderate to severe plaque psoriasis initiating secukinumab will be eligible for this study.
Who may be able to join
- Aged ≥ 18 years;
- Diagnosis of clinically moderate to severe plaque-psoriasis;
- Initiating treatment with secukinumab during the identification period or within 30 days prior to the index date;
- Patient agrees to sign the informed consent
Who cannot join
- Participation in any dermatology or rheumatology clinical trial, concurrent or within the last 30 days of the secukinumab initiating date
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
China42 sites
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Beijing, 100191
Novartis Investigative Site
Changchun, Jilin, 130041
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Changsha, Hunan, 410011
Novartis Investigative Site
Chengdu, Sichuan, 610017
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400010
Novartis Investigative Site
Chongqing, 400011
Novartis Investigative Site
Guangdong, Guangzhou, 510091
Novartis Investigative Site
Guangzhou, Guangdong, 510000
Novartis Investigative Site
Haikou, Hainan, 571127
Novartis Investigative Site
Handan, Hebei, 056002
Novartis Investigative Site
Jinan, Shandong, 250021
Novartis Investigative Site
Jinan, Shandong, 250022
Novartis Investigative Site
Jinan, 250012
Novartis Investigative Site
Lanzhou, Gansu, 730030
Novartis Investigative Site
Nanjing, 210042
Novartis Investigative Site
Qingdo, Shandong, 266033
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200071
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200072
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200437
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanyang, 110005
Novartis Investigative Site
Shenzhen, Guangdong, 518020
Novartis Investigative Site
Shenzhen, Guangdong, 518116
Novartis Investigative Site
Suzhou, Jiangsu, 215006
Novartis Investigative Site
Taiyuan, Shanxi, 030001
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300192
Novartis Investigative Site
Tianjin, 300052
Novartis Investigative Site
Ürümqi, Xinjiang, 830000
Novartis Investigative Site
Ürümqi, Xinjiang, 830001
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Novartis Investigative Site
Wuhan, Hubei, 430030
Novartis Investigative Site
Wuhan, 430022
Novartis Investigative Site
Xi’an, Shanxi, 710061
Novartis Investigative Site
Xian, Shanxi, 710004
Novartis Investigative Site
Xicheng Direct, Beijing Municipality, 100044
Novartis Investigative Site
Xuzhou, Jiangsu, 221003
Novartis Investigative Site
Yinchuan, Ningxia, 100039
Novartis Investigative Site
Zhejiang, 315016
Novartis Investigative Site
Zhengzhou, Henan, 450003
About this study
This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab.
Read the detailed description
All patients will be followed up for 52 weeks no matter they adhere to secukinumab or they have shifted to other treatment plans. Data will be collected in conjunction with routine care visits, most likely happen at week 0, 4, 12, 16, 24, 36, 52. No extra study visits, examinations, laboratory tests or procedures will be mandated. If visits happen at other time points (not within the window period), then they will be counted as unscheduled visits.
- Conditions
- Psoriasis
- Being tested
- secukinumab
- Keywords
- psoriasis, China, secukinumab, real world study
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumabDrug
Also called Cosentyx
There is no treatment allocation. Patients administered secukinumab by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| secukinumab | Patients administered secukinumab by prescription Receives: Drug: secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
Measured: week 24
Secondary outcomes (21)
Percentage of patients experiencing a 75% reduction of PASI (PASI75)
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
Measured: week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients experiencing a 90% reduction of PASI (PASI90)
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
Measured: week 4, week12, week 16, week 36, week 52
Percentage of patients experiencing a 100% reduction of PASI (PASI100)
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
Measured: week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients with absolute PASI change ≤1, ≤2, ≤3,and ≤5
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0
Measured: week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients with Investigator Global Assessment Mod 2011 (IGA mod 2011) 0 or 1
The IGA mod 2011 rating scale for overall psoriatic disease can range from 0 to 4 (0: Clear, 1: almost clear, 2: mild, 3: moderate, 4: severe)
Measured: week 4, week12, week 16, week 24, week 36, week 52
Mean change of Investigator Global Assessment Mod 2011(IGA mod 2011)
The IGA mod 2011 rating scale for overall psoriatic disease can range from 0 to 4 (0: Clear, 1: almost clear, 2: mild, 3: moderate, 4: severe)
Measured: week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients achieved (Body Surface Area) BSA≤1%
The total BSA affected by plaque-type psoriasis will be estimated from the percentages of areas affected, including head, trunk, upper limbs and lower limbs.
The following calculations will be done: each reported percentage will be multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages will be added up to estimate the total BSA affected by psoriasis.
Measured: week 4, week12, week 16, week 24, week 36, week 52
Mean change in Dermatology life quality index (DLQI)
DLQI is a 10-item general dermatology disability index designed to assess HRQoL in adult patients with skin diseases such as eczema, psoriasis, acne and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment and work/school.
Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. Additionally, each subscale of the DLQI may be analyzed separately.
Measured: Baseline,week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients achieving DLQI 0 or 1 response
DLQI is a 10-item general dermatology disability index designed to assess HRQoL in adult patients with skin diseases such as eczema, psoriasis, acne and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment and work/school.
Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment. Additionally, each subscale of the DLQI may be analyzed separately.
Measured: week 4, week12, week 16, week 24, week 36, week 52
Incidence of AEs/SAEs
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant
Measured: 52 weeks
Incidence of treatment-related AEs on-treatment and post-discontinuation follow up
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: 52 weeks
Incidence of unexpected treatment related AEs/SAEs on-treatment and post-discontinuation follow up
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant
Measured: 52 weeks
Incidence of treatment-related SAEs on-treatment and post-discontinuation follow up
Serious adverse event (SAE) is defined as an AE which results in death or is life-threatening, persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant
Measured: 52 weeks
Incidence of AEs of special interest on-treatment and post discontinuation follow up
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: 52 weeks
Proportion of patients experiencing at least one AE
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: 52 weeks
Average number of AEs per patient
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: 52 weeks
Percentage of secukinumab discontinuation caused by AE
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: 52 weeks
Frequency distribution of patients by dosing pattern
Frequency distribution of patients by dosing pattern will be collected
Measured: 52 weeks
Frequency distribution of patients by secukinumab retention
Percentage of patients who are persistent secukinumab users or who discontinue secukinumab
Measured: Week 4, week 12, week 16, week 24, week 36 and week 52
Mean (SD) time to secukinumab discontinuation
Mean (SD) time to secukinumab discontinuation will be collected
Measured: Up to 52 weeks
Median (interquartile range) time to secukinumab discontinuation
Median (IQR) time to secukinumab discontinuation will be collected
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start26 Sep 2021
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
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 Novartis PharmaceuticalsThe 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
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894890
- Sponsor's protocol ID
- CAIN457ACN06
- Acronym
- UNMASK2
- Status last verified
- Mar 2024
- First submitted
- 18 May 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
- ClinicalTrials.gov ID
- NCT04894890
- Acronym / sponsor ID
- UNMASK2 / CAIN457ACN06
- Conditions
- Psoriasis
- Keywords
- psoriasis, China, secukinumab, real world study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 20 May 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.
This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab.
Detailed description
All patients will be followed up for 52 weeks no matter they adhere to secukinumab or they have shifted to other treatment plans. Data will be collected in conjunction with routine care visits, most likely happen at week 0, 4, 12, 16, 24, 36, 52. No extra study visits, examinations, laboratory tests or procedures will be mandated. If visits happen at other time points (not within the window period), then they will be counted as unscheduled visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| secukinumab | – | Drug: secukinumabPatients administered secukinumab by prescription |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed diagnosis of moderate to severe plaque psoriasis initiating secukinumab will be eligible for this study.
Key inclusion criteria (4 listed)
- Aged ≥ 18 years;
- Diagnosis of clinically moderate to severe plaque-psoriasis;
- Initiating treatment with secukinumab during the identification period or within 30 days prior to the index date;
- Patient agrees to sign the informed consent
Key exclusion criteria (1 listed)
- Participation in any dermatology or rheumatology clinical trial, concurrent or within the last 30 days of the secukinumab initiating date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secukinumabAlso: CosentyxThere is no treatment allocation. Patients administered secukinumab by prescription that have started before inclusion of the patient into the study will be enrolled. | Drug | secukinumab |
Primary outcome
Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score
Time frame: week 24
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
21 secondary outcomes
Percentage of patients experiencing a 75% reduction of PASI (PASI75)
Time frame: week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients experiencing a 90% reduction of PASI (PASI90)
Time frame: week 4, week12, week 16, week 36, week 52
Percentage of patients experiencing a 100% reduction of PASI (PASI100)
Time frame: week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients with absolute PASI change ≤1, ≤2, ≤3,and ≤5
Time frame: week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients with Investigator Global Assessment Mod 2011 (IGA mod 2011) 0 or 1
Time frame: week 4, week12, week 16, week 24, week 36, week 52
Mean change of Investigator Global Assessment Mod 2011(IGA mod 2011)
Time frame: week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients achieved (Body Surface Area) BSA≤1%
Time frame: week 4, week12, week 16, week 24, week 36, week 52
Mean change in Dermatology life quality index (DLQI)
Time frame: Baseline,week 4, week12, week 16, week 24, week 36, week 52
Percentage of patients achieving DLQI 0 or 1 response
Time frame: week 4, week12, week 16, week 24, week 36, week 52
Incidence of AEs/SAEs
Time frame: 52 weeks
Incidence of treatment-related AEs on-treatment and post-discontinuation follow up
Time frame: 52 weeks
Incidence of unexpected treatment related AEs/SAEs on-treatment and post-discontinuation follow up
Time frame: 52 weeks
Incidence of treatment-related SAEs on-treatment and post-discontinuation follow up
Time frame: 52 weeks
Incidence of AEs of special interest on-treatment and post discontinuation follow up
Time frame: 52 weeks
Proportion of patients experiencing at least one AE
Time frame: 52 weeks
Average number of AEs per patient
Time frame: 52 weeks
Percentage of secukinumab discontinuation caused by AE
Time frame: 52 weeks
Frequency distribution of patients by dosing pattern
Time frame: 52 weeks
Frequency distribution of patients by secukinumab retention
Time frame: Week 4, week 12, week 16, week 24, week 36 and week 52
Mean (SD) time to secukinumab discontinuation
Time frame: Up to 52 weeks
Median (interquartile range) time to secukinumab discontinuation
Time frame: 52 weeks
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 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
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Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
42 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 Novartis Pharmaceuticals at 42 sites in China.
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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in China. 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?
Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score (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 20 Mar 2024.