Post-marketing surveillance of Cosentyx (secukinumab) for hidradenitis suppurativa, pediatric plaque psoriasis, and juvenile idiopathic arthritis 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

This study will see how Cosentyx (secukinumab) works and is tolerated in people in Korea with moderate-to-severe hidradenitis suppurativa, pediatric plaque psoriasis, or juvenile idiopathic arthritis who are being treated in routine care.

Quick facts

• Study type: Observational
• Enrollment: 76 (estimated)
• Ages: 6 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: secukinumab
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT07243782 on ClinicalTrials.gov

What this trial studies

This is a multicenter, single-arm, prospective observational post-marketing surveillance of patients in Korea treated with Cosentyx within approved indications. Treatment decisions are made by the treating physician as part of routine care and no additional diagnostics or monitoring beyond standard practice are required. The study enrolls adults (≥18) with moderate-to-severe hidradenitis suppurativa and children aged 6–18 with moderate-to-severe plaque psoriasis or enthesitis-related/juvenile psoriatic arthritis receiving Cosentyx. Data on safety, tolerability, and routine clinical outcomes will be collected during standard clinic visits.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with moderate-to-severe hidradenitis suppurativa or children aged 6–18 with moderate-to-severe plaque psoriasis or enthesitis-related/juvenile psoriatic arthritis who are receiving or will receive Cosentyx and can give consent.

Not a fit: Patients not receiving Cosentyx, outside the specified age ranges or diagnostic categories, or with contraindications to secukinumab are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could provide local real-world safety and tolerability data to help clinicians and regulators optimize Cosentyx use in Korean patients.

How similar studies have performed: Large randomized trials and post-marketing experience have demonstrated efficacy and an acceptable safety profile for secukinumab in these indications, but Korea-specific post-marketing data are limited.

Eligibility criteria

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

Where this trial is running

Seoul, Seoul

• Novartis Investigative Site — Seoul, Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Hidradenitis Suppurativa; Pediatric Plaque Psoriasis; Juvenile Idiopathic Arthritis