A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Other: Placebo; Drug: Ustekinumab - Half-Standard Dosage; Drug: Ustekinumab - Standard Dosage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090427

2009-014368-20 (EudraCT Number)

CADMUS (Other Identifier)

CNTO1275PSO3006 (Other Identifier)

CR017053

Details and patient eligibility

About

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

Full description

This is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a Treatment period. In treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week 12 and participants receiving placebo at Week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40. Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared or minimal disease. Participants' safety will be monitored throughout the study.

Enrollment: 110 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 3 patient groups

Ustekinumab Half-standard Dosage

Experimental group

Description:

Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.

Treatment:

Other: Placebo

Drug: Ustekinumab - Half-Standard Dosage

Ustekinumab Standard Dosage

Experimental group

Description:

Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.

Treatment:

Other: Placebo

Drug: Ustekinumab - Standard Dosage

Placebo

Experimental group

Description:

Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40.

Treatment:

Other: Placebo