This is a study of the safety and efficiacy of ustekinumab (CNTO1275) in adolescent patients with moderate to severe psoriasis.
- Conditions
- Moderate to Severe Plaque-type PsoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2009-014368-20-Outside-EU/EEA
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 150
Adolescent subjects = 12 to < 18 years of age who 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
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 or 5 times the halflife of the agent (whichever is longer).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of adolescent subjects = 12 to < 18 years of age with moderate to severe chronic plaque psoriasis.;Primary end point(s): Proportion of patients who achieve a Physician's Global Assessment (PGA) score of cleared or minimal disease;Timepoint(s) of evaluation of this end point: week 12;Secondary Objective: The secondary objectives of this study are to:<br><br>1. Evaluate the impact of ustekinumab on physical, social, emotional, and academic functioning as well as dermatologic symptom impact on health-related quality of life in adolescent subjects with moderate to severe chronic plaque psoriasis.<br><br>2. Evaluate the pharmacokinetics and immunogenicity of ustekinumab in adolescent subjects with moderate to severe chronic plaque psoriasis.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: week 12;Secondary end point(s): Proportion of patients that achieve Psoriasis Area and Severity Index (PASI) 75 response<br><br>Change from baseline in Children's Dermatology Life Quality Index<br>(CDLQI)<br><br>The proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) 90 response