Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis
Status: | Recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 6 - 17 |
Updated: | 3/29/2019 |
Start Date: | August 29, 2018 |
End Date: | September 15, 2023 |
Contact: | Novartis Pharmaceuticals |
Email: | novartis.email@novartis.com |
Phone: | 1-888-669-6682 |
A Randomized, Open-label, Multicenter Trial to Assess the Efficacy of Subcutaneous Secukinumab after12 Weeks of Treatment, and to Assess the Long-term Safety, Tolerability, Efficacy in Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
This is an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged
6 years to less than 18 years, at randomization, with moderate to severe chronic plaque
psoriasis. Approximately 80 subjects (at least 60 subjects with moderate severity) will be
enrolled. subjects will be stratified by weight. It is expected that subjects will be
enrolled in about 40 centers worldwide.
6 years to less than 18 years, at randomization, with moderate to severe chronic plaque
psoriasis. Approximately 80 subjects (at least 60 subjects with moderate severity) will be
enrolled. subjects will be stratified by weight. It is expected that subjects will be
enrolled in about 40 centers worldwide.
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. Subject being regarded by the investigator to be a candidate for systemic therapy.
Exclusion 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
We found this trial at
8
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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