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Evaluating the effectiveness of secukinumab in children with psoriasis

Prospective Observational Study With Retrospective Part to Evaluate Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Moderate-to-severe Plaque Psoriasis

Observational Novartis · NCT06142357

This study is testing how well the medication secukinumab works for children aged 6 to 17 with moderate-to-severe psoriasis and if they can tolerate it over time.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages6 Years to 18 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionssecukinumab
Locations15 sites (Chelyabinsk and 14 other locations)
Trial IDNCT06142357 on ClinicalTrials.gov

What this trial studies

This observational study focuses on pediatric patients aged 6 to 17 years with moderate-to-severe plaque psoriasis who are prescribed secukinumab. It involves retrospective data collection at the time of patient inclusion, followed by prospective data collection during routine follow-up visits for up to 104 weeks. The study aims to assess the drug's survival, effectiveness, and tolerability in a real-world clinical setting. The data will be gathered from multiple healthcare facilities treating pediatric psoriasis patients.

Who should consider this trial

Good fit: Ideal candidates for this study are pediatric patients aged 6 to 17 years with a diagnosis of moderate-to-severe plaque psoriasis who have failed or are intolerant to prior treatments.

Not a fit: Patients with severe hypersensitivity to secukinumab or those with a history of chronic recurrent infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of secukinumab for treating psoriasis in children.

How similar studies have performed: Other studies have shown promising results with secukinumab in adult populations, but this specific approach in pediatric patients is less explored.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.
2. Age ≥6 to \<18 years old.
3. Established diagnosis of active moderate-to-severe plaque psoriasis defined as a PASI score ≥ 10, body surface area (BSA) involvement of ≥10% and PGA score ≥ 3 only or with concomitant psoriatic arthritis.
4. Failure or intolerance of prior psoriasis treatment.
5. Patient was prescribed with secukinumab within 4-16 weeks before inclusion.
6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct.

Exclusion Criteria:

1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
2. History of chronic recurrent infection.
3. Clinically significant infection exacerbation, including active tuberculosis.
4. Age \<6 years or ≥18 years.
5. Pregnancy and breastfeeding.
6. Patients participating in parallel in an interventional clinical trial.
7. Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab.
8. Patients within the safety follow-up phase of interventional study.
9. Active inflammatory bowel disease at inclusion.
10. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
11. Any medical or psychological condition in the investigator's opinion which may prevent the study participation.

Where this trial is running

Chelyabinsk and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate-to-severe Plaque PsoriasisSecukinumab,psoriasis,pediatric patients,NIS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.