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

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Ustekinumab - Half-Standard Dosage (Drug); Ustekinumab - Standard Dosage (Drug); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

Summary

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

Clinical Details

Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12

Secondary outcome:

The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups

The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups

The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12

The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12

The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12

The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1

Detailed 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.

Eligibility

Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): Both.

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

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

Locations and Contacts

Brussel, Belgium

Gent, Belgium

Liege, Belgium

Quebec, Canada

Bordeaux, France

Nantes, France

Nice, France

St Etienne, France

Toulouse Cedex 9, France

Berlin, Germany

Dresden, Germany

Erlangen, Germany

Essen, Germany

Hamburg, Germany

Kiel, Germany

Mainz, Germany

Budapest N/A, Hungary

Debrecen, Hungary

Szeged, Hungary

Braga, Portugal

Lisboa, Portugal

Porto, Portugal

Vila Nova De Gaia, Portugal

Ekaterinburg, Russian Federation

Korolev, Russian Federation

Krasnodar, Russian Federation

Moscow, Russian Federation

Rostov-On-Don, Russian Federation

Saratov, Russian Federation

Linköping, Sweden

Stockholm, Sweden

Dnipropetrovsk, Ukraine

Ivano-Frankivsk, Ukraine

Khmelnitskiy, Ukraine

Kiev, Ukraine

Simferopol, Ukraine

Uzhgorod, Ukraine

Zaporozhye, Ukraine

Cardiff, United Kingdom

London, United Kingdom

York, United Kingdom

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Moncton, New Brunswick, Canada

St. John'S, Newfoundland and Labrador, Canada

Halifax, Nova Scotia, Canada

Kitchener, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Additional Information

Starting date: May 2010
Last updated: January 16, 2015

Page last updated: August 23, 2015

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