Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis

NCT06142357 | Active Not Recruiting

• 1 other identifier: CAIN457LRU01
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 16

Brief Summary

Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.

Conditions

Moderate-to-severe Plaque Psoriasis

Keywords

Secukinumab,; psoriasis,; pediatric patients,; NIS

Outcome Measures

Primary Outcomes (1)

• Drug survival rate of secukinumab

  Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab (defined as ≥2 missed consecutive doses with drug discontinuation proved by investigator in eCRF).

  52 weeks

Secondary Outcomes (9)

• Secukinumab survival rates

  Week 24, week 52, and week 104 after the index date

• Time to treatment discontinuation due to ineffectiveness

  Week 12, week 24, week 52, week 104

• Proportion of patients achieving PASI 75 responses

  Baseline (study inclusion), week 24, week 52, and week 104 after the index date

• Proportion of patients achieving PASI 90 responses

  Baseline (study inclusion), week 24, week 52, and week 104 after the index date

• Proportion of patients achieving PASI 100 responses

  Baseline (study inclusion), week 24, week 52, and week 104 after the index date

Study Arms (1)

Secukinumab

Pediatric patients with moderate-to-severe plaque psoriasis receiving secukinumab.

Other: Secukinumab

Interventions

Secukinumab OTHER

There is no treatment allocation. Patients administered secukinumab by prescription will be enrolled

Also known as: Cosentyx

Secukinumab

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged ≥6 to \<18 years old with moderate-to-severe plaque psoriasis after failure/intolerance of frontline treatment in routine clinical practice.

You may qualify if:

• Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.
• Age ≥6 to \<18 years old.
• 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.
• Failure or intolerance of prior psoriasis treatment.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (16)

Novartis Investigative Site

Chelyabinsk, 454048, Russia

Location

Novartis Investigative Site

Grozny, 364022, Russia

Location

Novartis Investigative Site

Izhevsk, 426009, Russia

Location

Novartis Investigative Site

Kazan', 420012, Russia

Location

Novartis Investigative Site

Kemerovo, 650025, Russia

Location

Novartis Investigative Site

Moscow, 105007, Russia

Location

Novartis Investigative Site

Moscow, 117513, Russia

Location

Novartis Investigative Site

Moscow, 119296, Russia

Location

Novartis Investigative Site

Moscow, 119435, Russia

Location

Novartis Investigative Site

Mytishchi, 141009, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, 603950, Russia

Location

Novartis Investigative Site

Rostov-on-Don, 344022, Russia

Location

Novartis Investigative Site

Tolyatti, 445846, Russia

Location

Novartis Investigative Site

Tula, 300053, Russia

Location

Novartis Investigative Site

Ufa, 450000, Russia

Location

Novartis Investigative Site

Yakutsk, 677000, Russia

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 21, 2023
• Study Start: December 29, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (16)