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

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rosacea

Rash

Skin Wounds

Treatment

Secukinumab

Clinical Study ID

NCT06142357
CAIN457LRU01
  • Ages 6-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent and legal representative's permission for studyparticipation 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 aPASI score ≥ 10, body surface area (BSA) involvement of ≥10% and PGA score ≥ 3 onlyor 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 accordingto the approved national label during routine clinical practice, regardless of thisnon-interventional study conduct.

Exclusion

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-interventionalstudy 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 mayprevent the study participation.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Secukinumab
Phase:
Study Start date:
December 29, 2023
Estimated Completion Date:
July 31, 2027

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Chelyabinsk, 454048
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Grozny, 364022
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Izhevsk, 426009
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kazan, 420012
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kemerovo, 650025
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Moscow, 105007
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Mytishchi, 141009
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Nizhniy Novgorod, 603950
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Nizhny Novgorod, 603066
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Rostov On Don, 344022
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Saint-Petersburg, 194100
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Tula, 300053
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Ufa, 450000
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Yakutsk, 677000
    Russian Federation

    Active - Recruiting

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