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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484587
• Other study ID #: CR018646
• Secondary ID: CNTO1959PSO1002
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2011
• Last updated: September 1, 2017
• Start date: August 22, 2011
• Est. completion date: April 11, 2013

Study information

• Verified date: September 2017
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 11, 2013
• Est. primary completion date: April 11, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and type of adverse events		Up to 24 weeks
Primary	Change in clinical laboratory values		Up to 24 weeks
Primary	Electrocardiogram		Up to 24 weeks
Primary	Changes or abnormalities in body systems		Up to 24 weeks
Primary	Axillary temperature		Up to 24 weeks
Primary	Pulse rate		Up to 24 weeks
Primary	Blood pressure		Up to 24 weeks
Secondary	Blood levels of CNTO 1959		Up to 24 weeks
Secondary	Antibodies to CNTO 1959		Up to 24 weeks
Secondary	Psoriasis Area and Severity Index (PASI)	The PASI produces a numeric score that can range from 0 (no involvement) to 72 (90% to 100% involvement).	Up to 24 weeks
Secondary	Physician's Global Assessment (PGA)	Assessment of the patient's psoriasis status according to the following categories: induration, erythema, and scaling	Up to 24 weeks

External Links

•   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