Clinical trial NCT01484587: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Moderate to Severe Plaque-Type Psoriasis
Psoriasis
Plaque-type psoriasis
CNTO 1959
Japanese participants
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: The number and type of adverse events
timeFrame: Up to 24 weeks
measure: Change in clinical laboratory values
timeFrame: Up to 24 weeks
measure: Electrocardiogram
timeFrame: Up to 24 weeks
measure: Changes or abnormalities in body systems
timeFrame: Up to 24 weeks
measure: Axillary temperature
timeFrame: Up to 24 weeks
measure: Pulse rate
timeFrame: Up to 24 weeks
measure: Blood pressure
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Blood levels of CNTO 1959
timeFrame: Up to 24 weeks
measure: Antibodies to CNTO 1959
timeFrame: Up to 24 weeks
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Up to 24 weeks
measure: Physician's Global Assessment (PGA)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Sapporo
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: