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NCT Number: NCT06142357

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Moderate-to-severe Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Chelyabinsk, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patient was prescribed with secukinumab within 4-16 weeks before inclusion.
  • 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

  • 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.
  • Active inflammatory bowel disease at inclusion.
  • 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.

Treatment and study plan

secukinumab

Other

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

Other names: Cosentyx

Primary outcomes

  1. Drug survival rate of secukinumab

    Time frame: 52 weeks

    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).

Secondary outcomes

  1. Secukinumab survival rates

    Time frame: Week 24, week 52, and week 104 after the index date

    Secukinumab survival rate is defined as proportion of patients who have not discontinued treatment due to reasons other than lack of efficacy.

  2. Time to treatment discontinuation due to ineffectiveness

    Time frame: Week 12, week 24, week 52, week 104

    Time from index date to treatment discontinuation due to ineffectiveness

  3. Proportion of patients achieving PASI 75 responses

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

    Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis.

    A PASI 75 represents an improvement in the PASI score of at least 75% as compared with baseline.

  4. Proportion of patients achieving PASI 90 responses

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

    Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis.

    A PASI 90 represents an improvement in the PASI score of at least 90% as compared with baseline.

  5. Proportion of patients achieving PASI 100 responses

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

    Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis.

    A PASI 100 response corresponds to complete clearing of psoriasis (PASI = 0).

  6. Proportion of patients achieving a physicians' global assessment (PGA) 0/1 response

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

    Proportion of patients achieving a physicians' global assessment 0/1 response: clear/almost clear skin

  7. Adverse events (AEs) of special interest

    Time frame: Week 12, week 24, week 52, week 104 after the index date

    Adverse events (AEs) of special interest:

    Inflammatory Bowel Disease, malignancy, tuberculosis, serious infections, candidiasis, acute injection site reaction, immunogenicity

  8. Proportion of patients discontinued secukinumab by reason

    Time frame: Week 12, week 24, week 52 and week 104

    Proportion of patients discontinued secukinumab by reason:

    • Lack of efficacy
    • Adverse events
    • Administrative reasons (no medication available in the hospital, etc.)
    • Lack of patient's adherence
    • Patient's or legal representative's wish
    • Other

  9. Drug survival rate

    Time frame: 104 weeks

    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).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: SPARROW

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2023
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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