Moderate-to-severe Plaque PsoriasisSPARROWNCT06142357
Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis
An observational study of Moderate-to-severe Plaque Psoriasis, run by Novartis Pharmaceuticals at 16 sites in Russia.
Trial summary
Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Moderate-to-severe Plaque Psoriasis
- What is being tested?
- Secukinumab
- How many people
- 199 participants
- Where
- 16 sitesRussia
- Study dates
- 29 Dec 2023to 31 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Russia16 sites
Novartis Investigative Site
Chelyabinsk, 454048
Novartis Investigative Site
Grozny, 364022
Novartis Investigative Site
Izhevsk, 426009
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Kemerovo, 650025
Novartis Investigative Site
Moscow, 105007
Novartis Investigative Site
Moscow, 117513
Novartis Investigative Site
Moscow, 119296
Novartis Investigative Site
Moscow, 119435
Novartis Investigative Site
Mytishchi, 141009
Novartis Investigative Site
Nizhny Novgorod, 603950
Novartis Investigative Site
Rostov-on-Don, 344022
Novartis Investigative Site
Tolyatti, 445846
Novartis Investigative Site
Tula, 300053
Novartis Investigative Site
Ufa, 450000
Novartis Investigative Site
Yakutsk, 677000
About this study
Official title: 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.
Read the 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.
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Being tested
- Secukinumab
- Keywords
- Secukinumab,, psoriasis,, pediatric patients,, NIS
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabOther
Also called Cosentyx
There is no treatment allocation. Patients administered secukinumab by prescription will be enrolled
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Pediatric patients with moderate-to-severe plaque psoriasis receiving secukinumab. Receives: Other: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 52 weeks
Secondary outcomes (9)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start29 Dec 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142357
- Sponsor's protocol ID
- CAIN457LRU01
- Acronym
- SPARROW
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Individual data sharing
- No