Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 10 July 2023
• Main ID: NCT02471144
• Date of registration: 04/05/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis
• Scientific title: A Randomized, Double-blind, Placebo- and Active Controlled Multicenter Trial to Demonstrate Efficacy of Subcutaneous Secukinumab Compared to Placebo and Etanercept (in a Single-blinded Arm) After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, and Long-term Efficacy in Subjects From 6 to Less Than 18 Years of Age With Severe Chronic Plaque Psoriasis
• Date of first enrolment: September 29, 2015
• Target sample size: 162
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02471144
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Belgium, Brazil, Canada, Colombia, Egypt, Estonia, France, Germany, Guatemala, Hungary, Israel, Italy, Japan, Latvia, Poland, Romania, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria:

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

- Plaque-type psoriasis history for at least 3 months.

Severe plaque-type psoriasis meeting all of the following three criteria:

- PASI score of 20 or greater,

- Investigator's Global Assessment (IGA) score of 4

- Total body surface area (BSA) affected of 10% or greater.

- Patient being regarded by the investigator to be a candidate for systemic therapy
because of:

1. inadequate control of symptoms with topical treatment, or

2. failure to respond to or tolerate previous systemic treatment and/or UV therapy

Exclusion criteria

- Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
pustular, erythrodermic, guttate) at randomization.

- Current drug-induced psoriasis.

- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.

- Underlying condition (including, but not limited to metabolic, hematologic, renal,
hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal)
which in the opinion of the investigator significantly immunocompromises the subject
and/or places the subject at unacceptable risk for receiving an immunomodulatory
therapy

- History of an ongoing, chronic or recurrent infectious disease, or evidence of
untreated tuberculosis.

- History of lymphoproliferative disease or history of malignancy of any organ system
within the past 5 years.

- Pregnant or nursing (lactating) women.

- Other protocol-defined inclusion/exclusion criteria may apply.



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Severe Plaque-type Psoriasis

Intervention(s)

Biological: Experimental : Secukinumab low dose

Biological: Experimental: Secukinumab high dose

Biological: Placebo Comparator: Secukinumab Placebo

Biological: Active Comparator: Etanercept

Primary Outcome(s)

Number and Percentage of Participants Achieving a 75% Improvement From Baseline in PASI Score at Week 12 [Time Frame: 12 weeks]

Number and Percentage of Participants Who Showed Investigator's Global Assessment (IGA) Mod 2011 Response of 0 or 1 at Week 12 [Time Frame: 12 Weeks]

Secondary Outcome(s)

Change From Baseline in Psoriasis Area & Severity Index (PASI) Score at Week 12 [Time Frame: Week 12]

Number and Percentage of Participants Achieving a Children's DLQI Score of 0 or 1 Over Time up to Week 52 (Maintenance) [Time Frame: Weeks 24, 36, 52]

Number and Percentage of Participants With Clinically Important Reduction in Disability as Evaluated by CHAQ Questionnaire Over Time at Week 12 [Time Frame: Week 12]

Number and Percentage of Participants Achieving a 50%, 75%, 90% or 100% Improvement From Baseline in PASI Score and IGA Mod 2011 Score of 0 or 1 Up to Week 52 (Maintenance) [Time Frame: Weeks 16, 20, 24, 36, 48 and 52]

Change From Baseline in Psoriasis Area & Severity Index (PASI) Scores at Week 52 [Time Frame: Week 52]

Number and Percentage of Participants With Clinically Important Reduction in Disability as Evaluated by CHAQ Questionnaire Over Time at Week 52 [Time Frame: Week 52]

Percentage Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Score Up to Week 52 (Maintenance) [Time Frame: Weeks 24, 36, 52]

Number and Percentage of Participants Achieving a 50%, 75%, 90% or 100% Improvement From Baseline in PASI Score and IGA Mod 2011 Score of 0 or 1 up to Week 12 (Induction) [Time Frame: Weeks 4, 8]

Number and Percentage of Participants Achieving a 90% Improvement From Baseline in PASI Score at Week 12 [Time Frame: 12 weeks]

Number and Percentage of Participants Achieving a Children's DLQI Score of 0 or 1 Over Time up to Week 12 (Induction) [Time Frame: Weeks 4, 8, 12]

Number and Percentage of Participants Achieving a 50%, 100% Improvement From Baseline in PASI Score at Week 12 [Time Frame: 12 weeks]

Percentage Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Score Up to Week 12 (Induction) [Time Frame: Weeks 4, 8, 12]

Percentage of Participants in IGA Mod 2011 Score Categories at Week 12 [Time Frame: Week 12]

Percentage of Participants in IGA Mod 2011 Score Categories at Week 52 [Time Frame: Week 52]

Secondary ID(s)

2014-005663-32

CAIN457A2310

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/08/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02471144