Study of efficacy and safety of secukinumab in pediatric patients with severe 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: EUCTR2014-005663-32-EE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-07
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified