Study to assess the long-term safety, tolerability and efficacy the in pediatric patients of age 6 to less than 18 years, with moderate to severe chronic plaque psoriasis

A randomized, open-label, multicenter trial to assess the efficacy of subcutaneous secukinumab after twelve weeks of treatment, and to assess the long-term safety, tolerability and efficacy in subjects from 6 to less than 18 years of age with moderate to severe chronic plaque psoriasis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004515-39-BE

Enrollment

Registered

2018-06-06

Start date

2018-10-11

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

Interventions

Trade Name: Cosentyx Product Name: secukinumab Product Code: AIN457 (150 mg/1 mL) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022

Eligibility

Sex/Gender

All

Inclusion 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. History of plaque psoriasis for at least 3 months before randomization 5. Subject being regarded by the investigator to be a candidate for systemic therapy. Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects fulfilling any of the following 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 75 and IGA mod 2011 0/1 response (coprimary endpoints) at Week 12, compared to placebo (historical control).;Secondary Objective: To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 90 at Week 12, compared to placebo (historical control). To investigate the clinical safety and tolerability of secukinumab as assessed by growth, weight gain, vital signs, clinical laboratory variables, ECGs, and adverse event monitoring To evaluate the pharmacokinetics of the two secukinumab doses in subjects.;Primary end point(s): PASI 75 and IGA mod 2011 0 or 1 response;Timepoint(s) of evaluation of this end point: week 12	—

Measure

Time frame

Main Objective: To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 75 and IGA mod 2011 0/1 response (coprimary endpoints) at Week 12, compared to placebo (historical control).;Secondary Objective: To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 90 at Week 12, compared to placebo (historical control). To investigate the clinical safety and tolerability of secukinumab as assessed by growth, weight gain, vital signs, clinical laboratory variables, ECGs, and adverse event monitoring To evaluate the pharmacokinetics of the two secukinumab doses in subjects.;Primary end point(s): PASI 75 and IGA mod 2011 0 or 1 response;Timepoint(s) of evaluation of this end point: week 12

—

Secondary

Measure	Time frame
Secondary end point(s): 1. PASI 90 2. safety and tolerability 3. Pharmacokinetics ;Timepoint(s) of evaluation of this end point: 1. week 12 2. up to week 224 3. up to week 224	—

Countries

Argentina, Belgium, Czechia, Czech Republic, Estonia, Germany, Peru, Poland, Russian Federation, Spain, United States

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com+41 61 324 1111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026