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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014368-20-DE

Enrollment

150

Registered

2010-03-05

Start date

2011-01-06

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;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.;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	—

Measure

Time frame

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.;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.;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

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: week 12	—

Countries

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

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International N.V.

clinicaltrialsEU@its.jnj.com+3171524 2166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026