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

Moderate to Severe Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05388916
• Other study ID #: CAIN457A2406
• Status: Active, not recruiting
• Start date: September 8, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moderate to Severe Chronic Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Guangdong	Guangzhou
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Jinan
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shijiazhuang
China	Novartis Investigative Site	Xian	Shanxi
China	Novartis Investigative Site	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs/SAEs/AESIs type and frequency	Adverse events (AEs)/ Serious adverse events (SAEs)/Adverse events of special interest (AESIs) to be collected.	52 weeks
Secondary	Proportion 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).	Week 12
Secondary	Proportion 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.	Week 12
Secondary	Proportion 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).	Week 12
Secondary	Proportion 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.	Up to week 52
Secondary	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).	Up to week 52
Secondary	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.	Up to week 52