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

NCT05388916 | Completed

• 1 other identifier: CAIN457A2406
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Keywords

chronic plaque psoriasis; China; NIS; Cosentyx; secukinumab

Outcome Measures

Primary Outcomes (1)

• AEs/SAEs/AESIs type and frequency

  Adverse events (AEs)/ Serious adverse events (SAEs)/Adverse events of special interest (AESIs).

  52 weeks

Secondary Outcomes (6)

• Percentage of patients who achieved PASI 75 response

  Week 12

• Percentage of patients who achieved IGA mod 2011 0 or 1 response

  Week 12

• Percentage of patients who achieved PASI 90/100 response

  Week 12

• Percentage of patients who achieved PASI 75/90/100 response/IGA mod 2011 0 or 1 response over time

  Up to week 52

• Absolute value change from baseline of PASI score over time

  Up to week 52

Study Arms (1)

Cosentyx

Pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx

Other: Cosentyx

Interventions

Cosentyx OTHER

Prospective observational cohort study. There was treatment allocation.

Cosentyx

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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®.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Novartis Investigative Site

Guangzhou, Guangdong, 510091, China

Location

Novartis Investigative Site

Shijiazhuang, Hebei, 050000, China

Location

Novartis Investigative Site

Zhengzhou, Henan, 450018, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110004, China

Location

Novartis Investigative Site

Xian, Shanxi, 710004, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310009, China

Location

Novartis Investigative Site

Beijing, 100069, China

Location

Related Links

• Link to study results

MeSH Terms

Interventions

secukinumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: September 8, 2022
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)