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 is currently recruiting participants.
Verified April 2013 by Janssen Pharmaceutical K.K.
Sponsor:
Janssen Pharmaceutical K.K.
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01484587
First received: September 2, 2011
Last updated: April 12, 2013
Last verified: April 2013
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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
| Estimated Enrollment: | 32 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484587
Contacts
| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Locations
| Japan | |
| Recruiting | |
| 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
Additional 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: | April 12, 2013 |
| 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 May 16, 2013