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A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01484587
First received: September 2, 2011
Last updated: September 1, 2017
Last verified: September 2017
September 2, 2011
September 1, 2017
August 22, 2011
April 11, 2013   (Final data collection date for primary outcome measure)
  • The number and type of adverse events [ Time Frame: Up to 24 weeks ]
  • Change in clinical laboratory values [ Time Frame: Up to 24 weeks ]
  • Electrocardiogram [ Time Frame: Up to 24 weeks ]
  • Changes or abnormalities in body systems [ Time Frame: Up to 24 weeks ]
  • Axillary temperature [ Time Frame: Up to 24 weeks ]
  • Pulse rate [ Time Frame: Up to 24 weeks ]
  • Blood pressure [ Time Frame: Up to 24 weeks ]
Same as current
Complete list of historical versions of study NCT01484587 on ClinicalTrials.gov Archive Site
  • Blood levels of CNTO 1959 [ Time Frame: Up to 24 weeks ]
  • Antibodies to CNTO 1959 [ Time Frame: Up to 24 weeks ]
  • Psoriasis Area and Severity Index (PASI) [ Time Frame: Up to 24 weeks ]
    The PASI produces a numeric score that can range from 0 (no involvement) to 72 (90% to 100% involvement).
  • Physician's Global Assessment (PGA) [ Time Frame: Up to 24 weeks ]
    Assessment of the patient's psoriasis status according to the following categories: induration, erythema, and scaling
Same as current
Not Provided
Not Provided
 
A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis
A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 Following a Single Subcutaneous Administration in Japanese Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a single subcutaneous (SC, under the skin) dose administered to Japanese participants with moderate to severe plaque psoriasis.
This is a randomized (participants are assigned to treatment groups by chance), double-blind (participants and study personnel know what study agents are given), placebo-controlled (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), single-dose study. The study will include 24 participants: 4 groups of at least 6 participants each. If it is decided that additional data are needed to define the safety and tolerability of CNTO 1959, an additional group may be enrolled. A given dose level may be repeated in newly enrolled participants, or a lower or intermediate dose may be administered based on preliminary data. The total duration of participation will be approximately 30 weeks, which includes a screening period of up to 6 weeks before the administration of study agent. Participant safety will be monitored. Ascending doses of 10, 30, 100, and 300 mg dose of CNTO 1959 and placebo will be administered as single SC injections; however, 2 SC injections may be required for the 300 mg dose level. Dosing will be performed for 24 weeks.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Psoriasis
  • Drug: CNTO 1959
    CNTO 1959: type=range, unit=mg, number=10, 30, 100, 300, form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks
  • Drug: Placebo
    Placebo: form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks
  • Experimental: 001
    Intervention: Drug: CNTO 1959
  • Placebo Comparator: 002
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 11, 2013
April 11, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of plaque-type psoriasis at least 6 months prior to screening (participants with concurrent psoriatic arthritis may be enrolled)
  • Having plaque-type psoriasis covering at least 10% of total body surface area (BSA) at baseline
  • Has a Psoriasis Area and Severity Index (PASI) score of 12 or greater at baseline
  • Is a candidate for systemic phototherapy or systemic treatment of psoriasis (either new to treatment or having had previous treatment)
  • Has at least 2 plaques suitable for repeat biopsy (Only participants who consent separately to participate in this assessment. Refusal to give consent for this component does not exclude an individual from participation in the clinical study).

Exclusion Criteria:

  • Currently has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular)
  • Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  • Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g., secondary infection occurred on bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers
  • Has a history of latent, or active or opportunistic systemic infection with pathogens including, but not limited to, Klebsiella pneumoniae, Cryptococcus neoformans, Candida albicans, Toxoplasma gondii, and Pneumocystis jiroveci prior to screening
  • Has or has had a serious infection (e.g., sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to screening
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01484587
CR018646
CNTO1959PSO1002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
Not Provided
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP