Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea

Regulatory Post-Marketing Surveillance to Assess Safety and Effectiveness in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea : a rPMS Study

Regulatory Post-Marketing Surveillance in hidradenitis suppurativa, pediatric plaque psoriasis and JIA treated with Cosentyx®(secukinumab) in Korea

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa; Juvenile Idiopathic Arthritis; Pediatric Plaque Psoriasis
• Intervention / Treatment: Drug: Secukinumab

Detailed Description

This post-marketing study is a multicenter, single-arm, prospective, observational study.

Cosentyx is prescribed within the scope of the approved indications for hidradenitis suppurativa, pediatric plaque psoriasis, enthesitis-related arthritis and juvenile psoriatic arthritis in the juvenile idiopathic arthritis category. The decision to treat patients with the drug will be made within current clinical practice and will be clearly distinguished from the decision to include patients in this investigation. No additional diagnostics or monitoring will be performed for this study beyond what is typically performed in clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 76

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 06973
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.

Description

Inclusion Criteria:

Hidradenitis suppurativa:

1. Adults 18 years of age and older with moderate to severe hidradenitis suppurativa who are or will be receiving Cosentyx within the scope of approved indication.
2. Patients who have agreed to participate in study (written informed consent)

Pediatric plaque psoriasis:

1. Patients with moderate to severe plaque psoriasis between the ages of 6 and 18 years who are receiving or will receive Cosentyx within the scope of approved indication.
2. Patients with patient or guardian consent to participate in study (written informed consent)

Juvenile idiopathic arthritis:

1. Enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category patients with enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category between the ages of 6 and 18 years and are receiving or will receive Cosentyx within the scope of approved indication.
2. Patients with patient or guardian consent to participate in study (written informed consent)

Exclusion Criteria:

1. Patients who are contraindicated according to national prescribing information
2. Patients participating in other interventional clinical trials

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Secukinumab - HS; Participants with Hidradenitis Supurativa who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.	Drug: Secukinumab; This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.; Other Names: Cosentyx
Secukinumab - Pediatric plaque psoriasis; Participants with pediatric plaque psoriasis who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.	Drug: Secukinumab; This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.; Other Names: Cosentyx
Secukinumab - JIA; Participants with juvenile idiopathic arthritis who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.	Drug: Secukinumab; This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.; Other Names: Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants having Adverse Events (AEs) and Serious Adverse Events (SAEs) within each indication	All AEs, regardless of severity or causality, will be collected from all participants enrolled in the study.	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of paticipants achieving 50% reduction in hidradenitis suppurativa clinical response (HiSCR50) - HS participants	The HiSCR is a validated assessment tool developed for patients with hidradenitis suppurativa. It is a dichotomized clinical response assessment that measures the status of three types of lesions: abscesses, inflammatory nodules, and draining fistulas. HiSCR50 is defined as participants who have at least a 50% reduction in abscess and nodule count compared to baseline and no increase in the number of abscesses or draining tunnels.	12 and 24 weeks
Proportion of participants achieving a severity of 0 or 1 on the hidradenitis supurativa-physician's global assessment (HS-PGA) - HS participants	The HS-PGA is a global assessment of patients with hidradenitis suppurativa based on four clinical assessments [number of abscesses, number of draining fistulas, number of inflammatory nodules, and presence/absence of non-inflammatory nodules] to determine severity on a six-point scale, scores range from 0-5 based on the number of HS lesions ranges from clear to very severe.	12 and 24 weeks
Proportion of participants with a 55% or greater reduction in international hidradenitis suppurativa severity scoring system (IHS4-55) - HS participants	The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. HS4-55 is defined as participants who have at least a 55% reduction in IHS4 score compared to baseline.	12 and 24 weeks
Proportion of participants with a ≥30% reduction in Hidradenitis suppurativa-related skin pain numerical rating scale (NRS) - HS participants	The HS-related skin pain NRS is a numeric rating scale in which patients rate their pain at the time of the worst skin pain in the past 24 hours. The numeric rating scale is a fine-grained numeric version of a visual analogue scale (VAS) in which respondents select a number (0-10) that best reflects the intensity of their pain, ranging from 0 (no skin pain) to 10 (most severe skin pain)	12 and 24 weeks
Proportion of participants with an Hidradenitis supurativa flare - HS participants	An HS flare is a new or substantial worsening of clinical signs or symptoms.	12 and 24 weeks
Proportion of participants by Hurley stage - HS participants	The Hurley stage is a grading system for classifying the severity of hidradenitis suppurativa. Stage I is defined as abscess formation (single or multiple), no sinus tracts or cicatrization/scarring, Stage II is defined as recurrent abscesses with sinus tracts and scarring, single or multiple separated lesions, and Stage III is defined as diffuse or almost diffuse involvement, or multiple interconnected sinus tracts and abscesses across the entire area.	12 and 24 weeks
Change from baseline in Psoriasis Area and Severity Index (PASI) - Pediatric plaque psoriasis participants	The PASI is a composite index that combines the area of involvement of psoriatic lesions with the severity of the lesions. The PASI calculates the extent of redness/erythema, scaling, and thickness/thickness of psoriatic lesions and assesses their severity with a corresponding score. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.	12 and 24 weeks
Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 - Pediatric plaque psoriasis participants	The IGA mod 2011 score is used to determine the severity psoriasis symptoms. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	12 and 24 weeks
Change from baseline in active joints by Tender Joint Count (TJC) - JIA participants	A joint is classified as "active" when there is swelling, pain on movement, tenderness/pain on movement, and limitation of motion. It is also possible to classify a joint as "active" if only edema is present. Using digital pressure, joints that feel tender or show pain when moved are considered tender joints, and their counts are totaled to determine the tender joint count (TJC).	12 and 24 weeks
Change from baseline in active joints by swollen joint count (SJC)- JIA participants	A joint is classified as "active" when there is swelling, pain on movement, tenderness/pain on movement, and limitation of motion. It is also possible to classify a joint as "active" if only edema is present. Swollen joint count SJC is determined by physical examination of joint counts that are classified as either swollen or not swollen.	12 and 24 weeks
Change from baseline in clinical juvenile arthritis disease activity score (cJADAS) - JIA participants	The JADAS is a tool for assessing disease activity in Juvenile idiopathic arthritis that is composed of four items: joint count (number of active joints as assessed by a physician), physician global assessment of disease activity (VAS 0-10), parent/patient global assessment (VAS 0-10), and serum inflammatory markers (erythrocyte sedimentation rate (ESR)), which are scored separately and summed to calculate a score. The clinical JADAS (cJADAS) used in this study excludes serum inflammatory markers and is calculated by summing all the scores (0-10) obtained from each item, and the score is calculated from a minimum of 0 to a maximum of 30.	12 and 24 weeks
Physician evaluation of participant symptoms	Treatment effect is evaluated by physician based on clinical judgement and/or laboratory test results and classified in four categories.; Improved: improvement or maintenance of symptoms*, as determined by the investigator.; Unchanged: No significant change from pre-initiation of the investigational drug is identified, which is not considered a maintenance effect*.; Worsening: Symptoms are worse than before started taking the investigational drug.; Unevaluable: Unable to evaluate due to lost to follow-up, etc. * Maintenance effect: When there is a significant risk of worsening of symptoms if the medication is discontinued, or when substitution with an existing medication continues to have an equivalent effect.	12 and 24 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Arthritis, Juvenile; Hidradenitis Suppurativa; secukinumab
• Other Study ID Numbers: CAIN457MKR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No