Study of efficacy and safety of secukinumab in pediatric patients with severe plaque psoriasis.

• Register: EUCTR
• Last refreshed on: 24 August 2021
• Main ID: EUCTR2014-005663-32-LV
• Date of registration: 12/06/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy and safety of secukinumab in pediatric patients 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: 06/08/2015
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005663-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no; Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belgium, Brazil, Colombia, Egypt, Estonia, France, Germany, Guatemala, Hungary, Israel, Italy, Japan, Latvia, Poland, Romania, Spain, United Kingdom

Contacts

• Name: Florent Hartmann
• Affiliation: Novartis Pharma Services AG

• Name: Florent Hartmann
• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion criteria

Inclusion criteria:
1) Must be 6 to less than 18 years of age at the time of randomization
2) 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.
3) Patients being regarded by the investigator to be a candidate for systemic therapy because of: 1) inadequate control of symptoms with topical treatment 2) failure to respond to or tolerate previous systemic treatment and/or UV therapy

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 160
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:
1) Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) active at randomization.
2) Current drug-induced psoriasis.
3) Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
4) 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 of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
5) History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
6) Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

Trade Name: Cosentyx
Product Name: secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Etanercept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 0.8-

Primary Outcome(s)

Main Objective: To demonstrate superior efficacy of secukinumab versus placebo at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who had inadequate control of symptoms with topical treatment or failure to respond to or tolerate previous systemic treatment and/or UV therapy

Primary end point(s): The percentage of Participants achieving a 75% Improvement from Baseline in PASI Score. The percentage of Participants who showed Investgator's Global Assessment (IGA) mod 2011 response of 0 or 1

Secondary Objective: To assess the long term safety and tolerability of secukinumab in this pediatric age group and will describe the efficacy and safety of secukinumab compared to etanercept.
To provide efficacy and safety data to support the extension of label of secukinumab to include children and adolescents (6 years to <18 years) with severe chronic plaque psoriasis.
Other protocol-defined secondary objectives may apply.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Secondary end point(s): 1. Percentage of Participants achieving a 90% Improvement from baseline in PASI score
2. Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score
3. Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in (PASI ) Score and an IGA mod 2011 score of 0 or 1
4. Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) score and IGA mod 2011 0 or 1 score
5. Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score.
6. Percentage of participants achieving a Childrens' DLQI score of 0 or 1
7. To evaluate the effects of treatment of secukinumab on disability at Week 12 and over time up to Week 52 by use of the Childhood Health Assessment Questionnaire (CHAQ©) for subjects with history of psoriatic arthritis.
8. Patients' safety. Clinical safety and tolerability as assessed by growth, weight gain, tolerability of s.c. injections, vital signs, clinical laboratory variables, ECGs, and adverse events monitoring
Other protocol-defined endpoints may apply.

Timepoint(s) of evaluation of this end point: 1. 12 weeks
2. 12 weeks
3. Weeks 1, 2, 3, 4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32,36, 40, 44, 48
and 52
4. Baseline, week 1, 2, 3 ,4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32, 36,
40, 44, 48, and Week 52
5. Baseline, Weeks 4, 8, 12, 24, 36, 52
6. Baseline, Weeks 4, 8, 12, 24, 36, 52
7. Baseline, Weeks 4, 8, 12, 24, 36, 52
8. from screening to Week 252

Secondary ID(s)

CAIN457A2310

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 06/07/2015
Contact: