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

Phase 1

Conditions: Plaque Psoriasis
MedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2017-004515-39-PL

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 84

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br>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 <br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. PASI 90<br>2. safety and tolerability <br>3. Pharmacokinetics <br>;Timepoint(s) of evaluation of this end point: 1. week 12<br>2. up to week 224<br>3. up to week 224

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