This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Phase 1

• Conditions: Moderate to Severe Plaque-type Psoriasis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2009-014368-20-GB
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-31
• Study Completion: 2014-01-03
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months; Are candidates for phototherapy or systemic treatment of psoriasis; Have screening laboratory test results within the study parameters
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
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

Currently have nonplaque forms of psoriasis; Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab; Received conventional systemic therapies or phototherapy within the last 4 weeks; Received biologic therapies within the last 3 months

Study & Design

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