Clinical trial NCT05388916: A Real-world Study to Assess Safety and Effectiveness of Secukinumab in Pediatric Plaque Psoriasis Patients in China
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Keywords: chronic plaque psoriasis
China
NIS
Cosentyx
secukinumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese pediatric patients aged between 6 to less than 18 years and diagnosed with moderate to severe plaque psoriasis.

Brief summary: This is 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 are about to initiate Cosentyx® or have started Cosentyx® within the last 4 weeks and meet the eligibility criteria will be enrolled. Patients will be 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.) will be collected at each visit. No additional study visits, examinations, laboratory tests or procedures will be mandated throughout the study.

Eligibility criteria: Inclusion Criteria:

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®.

Exclusion Criteria:

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.

Primary outcomes:
measure: AEs/SAEs/AESIs type and frequency
timeFrame: 52 weeks
Secondary outcomes:
measure: Proportion of patients who achieved PASI 75 response
timeFrame: Week 12
measure: Proportion of patients who achieved IGA mod 2011 0 or 1 response
timeFrame: Week 12
measure: Proportion of patients who achieved PASI 90/100 response
timeFrame: Week 12
measure: Proportion of patients who achieved PASI 75/90/100 response/IGA mod 2011 0 or 1 response over time
timeFrame: Up to week 52
measure: Absolute value change from baseline of PASI score over time
timeFrame: Up to week 52
measure: Absolute value change from baseline of IGA mod 2011 score over time
timeFrame: Up to week 52
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Novartis Investigative Site
state: Guangzhou
city: Zhengzhou
country: China
facility: Novartis Investigative Site
state: Henan
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Xian
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: