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: March 15, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Psoriasis
Drug: CNTO 1959
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • The number and type of adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Change in clinical laboratory values [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Electrocardiogram [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Changes or abnormalities in body systems [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Axillary temperature [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Pulse rate [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood levels of CNTO 1959 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Antibodies to CNTO 1959 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index (PASI) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessment of the patient's psoriasis status according to the following categories: induration, erythema, and scaling


Enrollment: 24
Study Start Date: August 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484587

Locations
Japan
Sapporo, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01484587     History of Changes
Other Study ID Numbers: CR018646, CNTO1959PSO1002
Study First Received: September 2, 2011
Last Updated: March 15, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014