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-CZ
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-25
• Last Update Posted: 9 October 2023

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