Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis

NCT ID: NCT03668613

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2023-09-12

Brief Summary

This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified by weight and disease severity.

Detailed Description

This was an open-label, parallel group, two-arm, multi-center, trial in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic, plaque psoriasis. The study consists of 3 periods: screening (up to 4 weeks), treatment (Week 208) and post-treatment follow-up (Week 224).

Approximately 80 subjects (at least 60 subjects with moderate psoriasis) were planned to be enrolled in about 40 centers worldwide and targeted to have at least 5 subjects in the < 25kg body weight, and at least 10 subjects in each of the other two weight groups (25-< 50 kg and ≥ 50 kg). Adolescents (12-< 18 years) and children (6-< 12 years) were included from the beginning of this study, since the DMC had approved already the enrollment of children (6-< 12 years) in the study CAIN457A2310 (NCT02471144). Subjects received the appropriate dose based on their body weight category.

For the statistical analysis for outcome measures 1 and 2, there was no 'within study' control arm. A historical placebo control was obtained using data from qualifying trials and used as the comparator for the primary and key secondary endpoint analysis. This was in line with the guidance from and discussions with Health Authorities including FDA and EMA (PDCO), which suggested reducing placebo exposure as well as overall clinical trial burden for the pediatric population and accepted an extrapolation approach (EMA 2012). Historical placebo data included in this study were based on clinical appropriateness and alignment of definitions (endpoints, clinical disease population and time point of assessment). Integrated in the analysis were placebo data from Novartis-reported secukinumab adult placebo-controlled studies (CAIN457A2302 (NCT01544595 and NCT01365455), CAIN457A2303 (NCT01544595 and NCT01358578), CAIN457A2308 (NCT01555125) and CAIN457A2309 (NCT01636687)) and pediatric placebo-controlled study CAIN457A2310. In addition, pediatric placebo-controlled study data from the literature on other biologics (e.g. etanercept, ustekinumab) were utilized (Paller et al 2008, Landells et al 2015).

If the subject moved into a higher or lower weight group at two consecutive visits with weight measurements during the maintenance (from Week 12 onwards as assessed at 4 weekly visits or during extension treatment period (as assessed at scheduled site visits), then the subject was dosed according to the new (higher or lower) weight group respectively.

Conditions

Moderate to Severe Chronic Plaque-type Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

secukinumab low dose

secukinumab low dose

Group Type: EXPERIMENTAL

secukinumab low dose

Intervention Type: DRUG

dose depends on the weight group

secukinumab high dose

secukinumab high dose

Group Type: EXPERIMENTAL

secukinumab high dose

Intervention Type: DRUG

dose depends on the weight group

Interventions

secukinumab low dose

dose depends on the weight group

Intervention Type: DRUG

secukinumab high dose

dose depends on the weight group

Intervention Type: DRUG

Other Intervention Names

AIN457; AIN457

Eligibility Criteria

Inclusion Criteria

1. Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.

2. Must be 6 to less than 18 years of age at the time of randomization

3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization.

4. Subject being regarded by the investigator to be a candidate for systemic therapy.

Exclusion Criteria

1. Forms of psoriasis other than chronic plaque-type active at randomization

2. Drug-induced psoriasis

3. Ongoing use of prohibited treatments

4. Female subjects of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 16 weeks after stopping study treatment

5. Pregnant or nursing (lactating) females

6. Subjects with total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL at screening

7. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

First OC Dermatology

Fountain Valley, California, United States

Private Practice

Jacksonville, Florida, United States

Novartis Investigative Site

Lebanon, New Hampshire, United States

Texas Derm and Laser Specialists .

San Antonio, Texas, United States

Novartis Investigative Site

Brussels, , Belgium

Novartis Investigative Site

Liège, , Belgium

Novartis Investigative Site

Hradec Králové, CZE, Czechia

Novartis Investigative Site

Prague, Prague 1, Czechia

Novartis Investigative Site

Tartu, , Estonia

Novartis Investigative Site

Dresden, , Germany

Novartis Investigative Site

Münster, , Germany

Novartis Investigative Site

Lima, , Peru

Novartis Investigative Site

Warsaw, Mazowian, Poland

Novartis Investigative Site

Rzeszów, , Poland

Novartis Investigative Site

Wroclaw, , Poland

Novartis Investigative Site

Kazan', , Russia

Novartis Investigative Site

Krasnodar, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Esplugues de Llobregat, Barcelona, Spain

Novartis Investigative Site

Sabadell, Barcelona, Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Valencia, , Spain

Countries

United States; Belgium; Czechia; Estonia; Germany; Peru; Poland; Russia; Spain

References

Kingo K, Papanastasiou P, Beissert S, Lazareva S, Villa AV, Bartonova J, Ballona R, Bansal A, Martin R, Fan H, O'Doherty C, Ravichandran S, Magnolo N. Long-Term Efficacy and Safety of Secukinumab in Children and Adolescents with Moderate-to-Severe Chronic Plaque Psoriasis: Four-Year Results of a Randomized, Phase III, Open-Label Trial. Paediatr Drugs. 2025 Aug 28. doi: 10.1007/s40272-025-00715-4. Online ahead of print.

Reference Type: DERIVED

PMID: 40874954 (View on PubMed)

Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.

Reference Type: DERIVED

PMID: 37341961 (View on PubMed)

Magnolo N, Kingo K, Laquer V, Browning J, Reich A, Szepietowski JC, Keefe D, Papanastasiou P, Bao W, Forrer P, Patekar M. Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study. Paediatr Drugs. 2022 Jul;24(4):377-387. doi: 10.1007/s40272-022-00507-0. Epub 2022 Jun 13.

Reference Type: DERIVED

PMID: 35698000 (View on PubMed)

Magnolo N, Kingo K, Laquer V, Browning J, Reich A, Szepietowski JC, Keefe D, Mazur R, Ghelani P, Forrer P, Wraith L, Patekar M. A phase 3 open-label, randomized multicenter study to evaluate efficacy and safety of secukinumab in pediatric patients with moderate to severe plaque psoriasis: 24-week results. J Am Acad Dermatol. 2022 Jan;86(1):122-130. doi: 10.1016/j.jaad.2021.08.066. Epub 2021 Sep 30.

Reference Type: DERIVED

PMID: 34555481 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2306

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

2017-004515-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457A2311

Identifier Type: -

Identifier Source: org_study_id