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

NCT ID: NCT06142357

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-29

Study Completion Date

2027-08-31

Brief Summary

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

Detailed Description

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This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks Retrospective data collection is planned at patients' inclusion. Prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.

Conditions

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Moderate-to-severe Plaque Psoriasis

Keywords

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Secukinumab, psoriasis, pediatric patients, NIS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Secukinumab

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

Secukinumab

Intervention Type OTHER

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

Interventions

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Secukinumab

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

Intervention Type OTHER

Other Intervention Names

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Cosentyx

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Chelyabinsk, , Russia

Site Status

Novartis Investigative Site

Grozny, , Russia

Site Status

Novartis Investigative Site

Izhevsk, , Russia

Site Status

Novartis Investigative Site

Kazan', , Russia

Site Status

Novartis Investigative Site

Kemerovo, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Mytishchi, , Russia

Site Status

Novartis Investigative Site

Nizhny Novgorod, , Russia

Site Status

Novartis Investigative Site

Rostov-on-Don, , Russia

Site Status

Novartis Investigative Site

Tolyatti, , Russia

Site Status

Novartis Investigative Site

Tula, , Russia

Site Status

Novartis Investigative Site

Ufa, , Russia

Site Status

Novartis Investigative Site

Yakutsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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CAIN457LRU01

Identifier Type: -

Identifier Source: org_study_id