Moderate to Severe Chronic Plaque PsoriasisNCT05388916
A Real-world Study to Assess Safety and Effectiveness of Secukinumab in Pediatric Plaque Psoriasis Patients in China
An observational study of Moderate to Severe Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals at 7 sites in China.
Trial summary
This was a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx® for up to 52 weeks. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- What is being tested?
- Cosentyx
- How many people
- 42 participants
- Where
- 7 sitesChina
- Study dates
- 8 Sep 2022to 27 Feb 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Chinese pediatric patients aged between 6 to less than 18 years and diagnosed with moderate to severe plaque psoriasis.
Who may be able to join
- Patients meeting all of the following criteria are eligible for inclusion in this study:
- Written assent and informed consent must be obtained as per local regulations prior to any study procedures.
- Diagnosed with moderate to severe plaque psoriasis.
- Initiating treatment with Cosentyx® or having started Cosentyx® treatment within the last 4 weeks in routine clinical practice, and its prescription is independent of this study.
- Aged 6 to less than 18 years at the time they are prescribed Cosentyx®.
- Have valid PASI and IGA mod 2011 score at the time they are prescribed Cosentyx®.
Who cannot join
- Patients meeting any of the following criteria are not eligible for inclusion in this study:
- Patients previously treated with other biologics.
- Patients participating in other clinical trials or who previously participated in clinical trials within 30 days before Cosentyx® initiation or a period of 5 half-lives of the investigational drug, whichever is longer.
- Patients in conditions which in the judgment of the clinical investigator renders the patient unsuitable for the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Novartis Investigative Site
Beijing, 100069
Novartis Investigative Site
Guangzhou, Guangdong, 510091
Novartis Investigative Site
Hangzhou, Zhejiang, 310009
Novartis Investigative Site
Shenyang, Liaoning, 110004
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
Novartis Investigative Site
Xian, Shanxi, 710004
Novartis Investigative Site
Zhengzhou, Henan, 450018
About this study
Official title: A Real-world, Prospective, Multicenter Study to Assess the Safety and Effectiveness of Secukinumab (Cosentyx®) in Patients Aged 6 to Less Than 18 Years With Moderate to Severe Chronic Plaque Psoriasis in China
This was a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx® for up to 52 weeks.
Read the detailed description
Patients who were about to initiate Cosentyx® or had started Cosentyx® within the last 4 weeks and met the eligibility criteria were enrolled. Patients were followed via routine visits in real clinical practice up to 52 weeks. Data from medical records, including safety and effectiveness information of Cosentyx® (e.g., AE, SAE, physical examinations, laboratory tests, disease assessments, etc.) were collected at each visit. No additional study visits, examinations, laboratory tests or procedures were mandated throughout the study.
- Being tested
- Cosentyx
- Keywords
- chronic plaque psoriasis, China, NIS, Cosentyx, secukinumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosentyxOther
Prospective observational cohort study. There was treatment allocation.
| Study group | Role | What they receive |
|---|---|---|
| Cosentyx | Pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx Receives: Other: Cosentyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs/SAEs/AESIs type and frequency
Adverse events (AEs)/ Serious adverse events (SAEs)/Adverse events of special interest (AESIs).
Measured: 52 weeks
Secondary outcomes (6)
Percentage of patients who achieved PASI 75 response
Percentage of participants who achieve 75% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
Measured: Week 12
Percentage of patients who achieved IGA mod 2011 0 or 1 response
The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and is not compared with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Measured: Week 12
Percentage of patients who achieved PASI 90/100 response
Percentage of participants who achieve 90/100% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
Measured: Week 12
Percentage of patients who achieved PASI 75/90/100 response/IGA mod 2011 0 or 1 response over time
Percentage of participants who achieve 75/90/100% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis.
The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and is not compared with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Measured: Up to week 52
Absolute value change from baseline of PASI score over time
Psoriasis Area and Severity Index (PASI) score s a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
Measured: Up to week 52
Absolute value change from baseline of IGA mod 2011 score over time
The Investigator's Global Assessment (IGA) mod 2011 scale scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Measured: Up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start8 Sep 2022
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Plaque 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
- 42 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
- NCT05388916
- Sponsor's protocol ID
- CAIN457A2406
- Status last verified
- Dec 2025
- First submitted
- 19 May 2022
- Last updated
- 29 Dec 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world, Prospective, Multicenter Study to Assess the Safety and Effectiveness of Secukinumab (Cosentyx®) in Patients Aged 6 to Less Than 18 Years With Moderate to Severe Chronic Plaque Psoriasis in China
- ClinicalTrials.gov ID
- NCT05388916
- Acronym / sponsor ID
- CAIN457A2406
- Keywords
- chronic plaque psoriasis, China, NIS, Cosentyx, secukinumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 24 May 2022 (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 was a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx® for up to 52 weeks.
Detailed description
Patients who were about to initiate Cosentyx® or had started Cosentyx® within the last 4 weeks and met the eligibility criteria were enrolled. Patients were followed via routine visits in real clinical practice up to 52 weeks. Data from medical records, including safety and effectiveness information of Cosentyx® (e.g., AE, SAE, physical examinations, laboratory tests, disease assessments, etc.) were collected at each visit. No additional study visits, examinations, laboratory tests or procedures were mandated throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cosentyx | – | Other: CosentyxPediatric patients with moderate to severe plaque psoriasis treated with Cosentyx |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Chinese pediatric patients aged between 6 to less than 18 years and diagnosed with moderate to severe plaque psoriasis.
Key inclusion criteria (6 listed)
- Written assent and informed consent must be obtained as per local regulations prior to any study procedures.
- Diagnosed with moderate to severe plaque psoriasis.
- Initiating treatment with Cosentyx® or having started Cosentyx® treatment within the last 4 weeks in routine clinical practice, and its prescription is independent of this study.
- Aged 6 to less than 18 years at the time they are prescribed Cosentyx®.
- Have valid PASI and IGA mod 2011 score at the time they are prescribed Cosentyx®.
Key exclusion criteria (4 listed)
- Patients meeting any of the following criteria are not eligible for inclusion in this study:
- Patients previously treated with other biologics.
- Patients participating in other clinical trials or who previously participated in clinical trials within 30 days before Cosentyx® initiation or a period of 5 half-lives of the investigational drug, whichever is longer.
- Patients in conditions which in the judgment of the clinical investigator renders the patient unsuitable for the study.
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 |
|---|---|---|
| CosentyxProspective observational cohort study. There was treatment allocation. | Other | Cosentyx |
Primary outcome
AEs/SAEs/AESIs type and frequency
Time frame: 52 weeks
Adverse events (AEs)/ Serious adverse events (SAEs)/Adverse events of special interest (AESIs).
6 secondary outcomes
Percentage of patients who achieved PASI 75 response
Time frame: Week 12
Percentage of patients who achieved IGA mod 2011 0 or 1 response
Time frame: Week 12
Percentage of patients who achieved PASI 90/100 response
Time frame: Week 12
Percentage of patients who achieved PASI 75/90/100 response/IGA mod 2011 0 or 1 response over time
Time frame: Up to week 52
Absolute value change from baseline of PASI score over time
Time frame: Up to week 52
Absolute value change from baseline of IGA mod 2011 score over time
Time frame: Up to week 52
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 29 Dec 2025.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals at 7 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 6 inclusion and 4 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
AEs/SAEs/AESIs type and frequency (time frame: 52 weeks). 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 29 Dec 2025.