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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate-to-severe Plaque Psoriasis
• Intervention / Treatment: Other: Secukinumab

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• Russia
  • Chelyabinsk, Russia, 454048
    • Novartis Investigative Site
  • Grozny, Russia, 364022
    • Novartis Investigative Site
  • Izhevsk, Russia, 426009
    • Novartis Investigative Site
  • Kazan', Russia, 420012
    • Novartis Investigative Site
  • Kemerovo, Russia, 650025
    • Novartis Investigative Site
  • Moscow, Russia, 105007
    • Novartis Investigative Site
  • Moscow, Russia, 117513
    • Novartis Investigative Site
  • Moscow, Russia, 119296
    • Novartis Investigative Site
  • Moscow, Russia, 119435
    • Novartis Investigative Site
  • Mytishchi, Russia, 141009
    • Novartis Investigative Site
  • Nizhny Novgorod, Russia, 603950
    • Novartis Investigative Site
  • Rostov-on-Don, Russia, 344022
    • Novartis Investigative Site
  • Tolyatti, Russia, 445846
    • Novartis Investigative Site
  • Tula, Russia, 300053
    • Novartis Investigative Site
  • Ufa, Russia, 450000
    • Novartis Investigative Site
  • Yakutsk, Russia, 677000
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Secukinumab; Pediatric patients with moderate-to-severe plaque psoriasis receiving secukinumab.	Other: Secukinumab; There is no treatment allocation. Patients administered secukinumab by prescription will be enrolled; Other Names: Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secukinumab survival rates	Secukinumab survival rate is defined as proportion of patients who have not discontinued treatment due to reasons other than lack of efficacy.	Week 24, week 52, and week 104 after the index date
Time to treatment discontinuation due to ineffectiveness	Time from index date to treatment discontinuation due to ineffectiveness	Week 12, week 24, week 52, week 104
Proportion of patients achieving PASI 75 responses	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.	Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Proportion of patients achieving PASI 90 responses	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.	Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Proportion of patients achieving PASI 100 responses	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).	Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Proportion of patients achieving a physicians' global assessment (PGA) 0/1 response	Proportion of patients achieving a physicians' global assessment 0/1 response: clear/almost clear skin	Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Adverse events (AEs) of special interest	Adverse events (AEs) of special interest: Inflammatory Bowel Disease, malignancy, tuberculosis, serious infections, candidiasis, acute injection site reaction, immunogenicity	Week 12, week 24, week 52, week 104 after the index date
Proportion of patients discontinued secukinumab by reason	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	Week 12, week 24, week 52 and week 104
Drug survival rate	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).	104 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: NIS; Secukinumab,; psoriasis,; pediatric patients,
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; secukinumab
• Other Study ID Numbers: CAIN457LRU01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO