This is a study of the safety and efficiacy of ustekinumab (CNTO1275) in adolescent patients with moderate to severe psoriasis.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2009-014368-20-DE
• Date of registration: 05/03/2010
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: This is a study of the safety and efficiacy of ustekinumab (CNTO1275) in adolescent patients with moderate to severe psoriasis.
• Scientific title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis - CADMUS
• Date of first enrolment: 06/01/2011
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014368-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4

Countries of recruitment

Belgium, Canada, France, Germany, Hungary, Portugal, Sweden, United Kingdom

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International N.V.

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International N.V.

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Moderate to Severe Plaque-type Psoriasis
MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Intervention(s)

Trade Name: STELARA
Pharmaceutical Form: Solution for injection
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Proportion of patients who achieve a Physician's Global Assessment (PGA) score of cleared or minimal disease

Secondary Objective: The secondary objectives of this study are to:

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.

2. Evaluate the pharmacokinetics and immunogenicity of ustekinumab in adolescent subjects with moderate to severe chronic plaque psoriasis.

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.

Timepoint(s) of evaluation of this end point: week 12

Secondary Outcome(s)

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

Change from baseline in Children's Dermatology Life Quality Index
(CDLQI)

The proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) 90 response

Secondary ID(s)

CNTO1275PSO3006

Source(s) of Monetary Support

Janssen Research & Development