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

Janssen (J&J Innovative Medicine) logo

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

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

Trial contacts and locations

50

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Data sourced from clinicaltrials.gov

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