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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01484587
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : September 5, 2017
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: CNTO 1959 Drug: Placebo Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 22, 2011
Actual Primary Completion Date : April 11, 2013
Actual Study Completion Date : April 11, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 001 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

Placebo Comparator: 002 Drug: Placebo
Placebo: form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks

Primary Outcome Measures :
  1. The number and type of adverse events [ Time Frame: Up to 24 weeks ]
  2. Change in clinical laboratory values [ Time Frame: Up to 24 weeks ]
  3. Electrocardiogram [ Time Frame: Up to 24 weeks ]
  4. Changes or abnormalities in body systems [ Time Frame: Up to 24 weeks ]
  5. Axillary temperature [ Time Frame: Up to 24 weeks ]
  6. Pulse rate [ Time Frame: Up to 24 weeks ]
  7. Blood pressure [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Blood levels of CNTO 1959 [ Time Frame: Up to 24 weeks ]
  2. Antibodies to CNTO 1959 [ Time Frame: Up to 24 weeks ]
  3. 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).

  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01484587

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Sapporo, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

Additional Information:
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Responsible Party: Janssen Pharmaceutical K.K. Identifier: NCT01484587     History of Changes
Other Study ID Numbers: CR018646
CNTO1959PSO1002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Pharmaceutical K.K.:
Moderate to Severe Plaque-Type Psoriasis
Plaque-type psoriasis
CNTO 1959
Japanese participants

Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases