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A Real-world Study to Assess Safety and Effectiveness of Secukinumab in Pediatric Plaque Psoriasis Patients in China

NCT ID: NCT05388916

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-08

Study Completion Date

2025-02-27

Brief Summary

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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

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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.

Conditions

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Moderate to Severe Chronic Plaque Psoriasis

Keywords

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chronic plaque psoriasis China NIS Cosentyx secukinumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cosentyx

Pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx

Cosentyx

Intervention Type OTHER

Prospective observational cohort study. There was treatment allocation.

Interventions

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Cosentyx

Prospective observational cohort study. There was treatment allocation.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Shijiazhuang, Hebei, China

Site Status

Novartis Investigative Site

Zhengzhou, Henan, China

Site Status

Novartis Investigative Site

Shenyang, Liaoning, China

Site Status

Novartis Investigative Site

Xian, Shanxi, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Countries

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China

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18397

Link to study results

Other Identifiers

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CAIN457A2406

Identifier Type: -

Identifier Source: org_study_id