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

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 Identifier: NCT05388916

Novartis Reference Number: CAIN457A2406

Last Update: Dec 21, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Moderate to Severe Chronic Plaque Psoriasis

Phase

Not Given

Overall status

Recruiting

Start date

Sep 08, 2022

Completion date

Apr 30, 2025

Gender

All

Age(s)

6 Years - 18 Years (Child, Adult)

Interventions

Other

Cosentyx

Prospective observational cohort study. There is no treatment allocation. Patients administered Cosentyx by prescription will be enrolled.

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.