STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PK OF SECUKINUMAB IN SUBJECTS 6 TO LESS THAN 18 YEARS OF AGE 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

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-031-18

Enrollment

Registered

2018-12-17

Start date

2024-11-01

Completion date

Unknown

Last updated

2024-03-12

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

Conditions

None listed

Interventions

Arm I Type of group

Low dose Group: sc secukinumab 75 mg (in

Arm II Type of group

High dose Group: sc secukinumab 75 mg (in

50 kg) injections will be administered at Randomization, Weeks 1, 2, 3, 4 and thereafter every 4 weeks during the entire treatment period of the study until Week 204.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Must be 6 to less than 18 years of age at the time of randomization. 2. 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 3. History of plaque psoriasis for at least 3 months before randomization

Exclusion criteria

Exclusion criteria: 1. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis), active at randomization. 2. Drug-induced psoriasis (ie new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium) 3. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor, 4. Subjects with an estimated Glomerular Filtration Rate (eGFR), estimated by the Schwartz equation, of < 60 mL/min/1.73 m2 at screening. Assessment may be repeated once, two or more days later, and if eGFR value  60, subject may be included at the discretion of the investigator.

Design outcomes

Primary

Measure	Time frame
Outcome name:Bayesian analysis Measure:Proportion of subjects who achieved PASI 75 and IGA mod 2011 0 or 1 r Timepoints:at Week 12 in each secukinumab treatment group (low dose and high dose).	—

Secondary

Measure	Time frame
Outcome name:Bayesian analysis Measure:Proportion of subjects who achieved PASI 90. Timepoints:at Week 12 in each secukinumab treatment group (low dose and high dose).	—

Countries

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

Contacts

Public ContactHedwig Schmidt

NOVARTIS BIOSCIENCES PERU S.A.

Hedwig.schmidt@novartis.com51 2006520

Outcome results