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

NCT03668613 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457A23112017-004515-39
• Study Type: interventional
• Target: 84
• Locations: 8 countries
• Sites: 22

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.

Conditions

Moderate to Severe Chronic Plaque-type Psoriasis

Keywords

pediatric; secukinumab; plaque psoriasis; AIN457A; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching

Outcome Measures

Primary Outcomes (2)

• Number and Percentage of Participants With PASI 75 Response

  Psoriasis Area and Severity Index (PASI):Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs and lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, Erythema,Thickening (plaque elevation, induration) \& Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head: 0.1, upper limbs: 0.2 body: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.

  Week 12

• Number and Percentage of Participants With IGA Mod 2011 0 or 1 Response

  Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease)

  Week 12

Secondary Outcomes (3)

• Number and Percentage of Participants With PASI 90 Response

  Week 12

• Secukinumab Concentration in Serum

  Baleine, Weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208

• Summary Table of Adverse Events

  Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks.

Study Arms (2)

secukinumab low dose

EXPERIMENTAL

secukinumab low dose

Drug: secukinumab low dose

secukinumab high dose

EXPERIMENTAL

secukinumab high dose

Drug: secukinumab high dose

Interventions

secukinumab low dose DRUG

dose depends on the weight group

Also known as: AIN457

secukinumab low dose

secukinumab high dose DRUG

dose depends on the weight group

Also known as: AIN457

secukinumab high dose

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.
• Must be 6 to less than 18 years of age at the time of randomization
• 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.
• Subject being regarded by the investigator to be a candidate for systemic therapy.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type active at randomization
• Drug-induced psoriasis
• Ongoing use of prohibited treatments
• 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
• Pregnant or nursing (lactating) females
• 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
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (23)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Private Practice

Jacksonville, Florida, 32256, United States

Location

Novartis Investigative Site

Lebanon, New Hampshire, 03756, United States

Location

Texas Derm and Laser Specialists .

San Antonio, Texas, 78218, United States

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Hradec Králové, CZE, 500 05, Czechia

Location

Novartis Investigative Site

Prague, Prague 1, 11000, Czechia

Location

Novartis Investigative Site

Tartu, 50406, Estonia

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Lima, 1, Peru

Location

Novartis Investigative Site

Warsaw, Mazowian, 02 495, Poland

Location

Novartis Investigative Site

Rzeszów, 35 055, Poland

Location

Novartis Investigative Site

Wroclaw, 50-566, Poland

Location

Novartis Investigative Site

Kazan', 420012, Russia

Location

Novartis Investigative Site

Krasnodar, 350020, Russia

Location

Novartis Investigative Site

Moscow, 119296, Russia

Location

Novartis Investigative Site

Saint Petersburg, 191123, Russia

Location

Novartis Investigative Site

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Valencia, 46026, Spain

Location

Related Publications (4)

• 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 Nov;27(6):749-759. doi: 10.1007/s40272-025-00715-4. Epub 2025 Aug 28.

  PMID: 40874954 DERIVED

• 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.

  PMID: 37341961 DERIVED

• 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.

  PMID: 35698000 DERIVED

• 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.

  PMID: 34555481 DERIVED

Related Links

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

MeSH Terms

Conditions

Skin Diseases; Recurrence; Plaque, Amyloid; Pruritus

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 12, 2018
• Study Start: August 29, 2018
• Primary Completion: September 19, 2019
• Study Completion: September 12, 2023
• Last Updated: May 16, 2025
• Results First Posted: July 23, 2021

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (4); CZ (2); PE (1); ES (4); DE (2); RU (4); BE (2); PL (3)