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Completed

NCT Number: NCT05388916

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

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.

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Key information

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Guangzhou, Guangdong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cosentyx

Other

Prospective observational cohort study. There was treatment allocation.

Primary outcomes

  1. AEs/SAEs/AESIs type and frequency

    Time frame: 52 weeks

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

Secondary outcomes

  1. Percentage of patients who achieved PASI 75 response

    Time frame: Week 12

    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).

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

    Time frame: Week 12

    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.

  3. Percentage of patients who achieved PASI 90/100 response

    Time frame: Week 12

    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).

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

    Time frame: Up to week 52

    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.

  5. Absolute value change from baseline of PASI score over time

    Time frame: Up to week 52

    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).

  6. Absolute value change from baseline of IGA mod 2011 score over time

    Time frame: Up to week 52

    The Investigator's Global Assessment (IGA) mod 2011 scale scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 24, 2022
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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