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

NCT07243782 | Recruiting

• 1 other identifier: CAIN457MKR01
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hidradenitis Suppurativa; Pediatric Plaque Psoriasis; Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Proportion of paticipants achieving 50% reduction in hidradenitis suppurativa clinical response (HiSCR50) - HS participants

  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

  12 and 24 weeks

• Proportion of participants with a 55% or greater reduction in international hidradenitis suppurativa severity scoring system (IHS4-55) - HS participants

  12 and 24 weeks

• Proportion of participants with a ≥30% reduction in Hidradenitis suppurativa-related skin pain numerical rating scale (NRS) - HS participants

  12 and 24 weeks

• Proportion of participants with an Hidradenitis supurativa flare - HS participants

  12 and 24 weeks

Study Arms (3)

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

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

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

Interventions

Secukinumab DRUG

This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Also known as: Cosentyx

Secukinumab - HS; Secukinumab - JIA; Secukinumab - Pediatric plaque psoriasis

Eligibility Criteria

• Age: 6 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Hidradenitis suppurativa:
• 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.
• Patients who have agreed to participate in study (written informed consent)
• Pediatric plaque psoriasis:
• 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.
• Patients with patient or guardian consent to participate in study (written informed consent)
• Juvenile idiopathic arthritis:
• 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.
• Patients with patient or guardian consent to participate in study (written informed consent)

You may not qualify if:

• Patients who are contraindicated according to national prescribing information
• Patients participating in other interventional clinical trials

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Seoul, Seoul, 06973, South Korea

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa; Arthritis, Juvenile

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)